Dignitana AB DigniCap System

DEN150010 · Dignitana AB · PMC · Dec 8, 2015 · General, Plastic Surgery

Device Facts

• Record ID: DEN150010
• Device Name: Dignitana AB DigniCap System
• Applicant: Dignitana AB
• Product Code: PMC · General, Plastic Surgery
• Decision Date: Dec 8, 2015
• Decision: DENG
• Submission Type: Direct
• Regulation: 21 CFR 878.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DigniCap™ Scalp Cooling System is indicated to reduce the likelihood of chemotherapy induced alopecia in women with breast cancer.

Device Story

DigniCap Scalp Cooling System; prescription device; reduces frequency/severity of chemotherapy-induced alopecia. System utilizes scalp cooling cap; regulates scalp temperature during chemotherapy administration. Cooling reduces blood flow to scalp; decreases uptake of chemotherapeutic agents in hair follicles. Operated in clinical setting; monitors temperature control; ensures patient safety. Provides benefit by mitigating hair loss; improves patient quality of life during treatment. Risks include thermal tissue damage, scalp pain, headache, chills, and potential risk of scalp metastases.

Clinical Evidence

Two clinical studies (feasibility N=20; pivotal N=101 treatment, N=16 control). Pivotal study: non-randomized, multi-center, concurrent controlled. Primary endpoint: Dean score ≤2 (≤50% hair loss) 4 weeks post-chemotherapy. Results: 66.3% treatment success vs 0% control (p < 0.001). Adverse events: headache (65%), chills (80%), scalp pain (95%). No serious device-related adverse events; no scalp metastasis reported in study follow-up.

Technological Characteristics

System includes refrigerated tank, liquid coolant (monopropylene glycol), silicone cap, and neoprene insulation. Temperature control: -8 ± 1 ℃ coolant; scalp temperature maintained at 3-5 ℃. Sensors: 3 thermometers in cap. Connectivity: DigniStick™ for data/updates. Electrical safety: IEC 60601-1:2005. EMC: IEC 60601-1-2:2007. Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization/irritation).

Indications for Use

Indicated for women with breast cancer to reduce the likelihood of chemotherapy-induced alopecia.

Regulatory Classification

Identification

A scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia is a prescription device intended to reduce the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used.

Special Controls

*Classification* —Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device meets all design specifications and performance requirements, and that the device performs as intended under anticipated conditions of use. This information must include testing to demonstrate accuracy of the temperature control mechanism. (2) Performance testing must demonstrate the electromagnetic compatibility and electrical safety of the device. (3) Software verification, validation, and hazard analysis must be performed. (4) The patient contacting components of the device must be demonstrated to be biocompatible. Material names must be provided. (5) Labeling must include the following: (i) A statement describing the potential risk of developing scalp metastasis. (ii) Information on the patient population and chemotherapeutic agents/regimen for which the device has been demonstrated to be effective. (iii) A summary of the non-clinical and/or clinical testing pertinent to use of the device. (iv) A summary of the device technical parameters, including temperature cooling range and duration of cooling. (v) A summary of the device- and procedure-related adverse events pertinent to use of the device. (vi) Information on how the device operates and the typical course of treatment. (6) Patient labeling must be provided and must include: (i) Relevant contraindications, warnings, precautions, and adverse effects/complications. (ii) Information on how the device operates and the typical course of treatment. (iii) Information on the patient population for which there is clinical evidence of effectiveness. (iv) The potential risks and benefits associated with use of the device. (v) Postoperative care instructions. (vi) A statement describing the potential risk of developing scalp metastasis.

Submission Summary (Full Text)

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#### DE NOVO CLASSIFICATION REQUEST FOR DIGNICAP™ SCALP COOLING SYSTEM

#### REGULATORY INFORMATION

FDA identifies this generic type of device as:

Scalp cooling system to reduce the likelihood of chemotherapy induced alopecia: A scalp cooling system is intended to reduce the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used.

NEW REGULATION NUMBER: 878.4360

CLASSIFICATION: II

PRODUCT CODE: PMC

#### BACKGROUND

DEVICE NAME: DIGNICAP™ SCALP COOLING SYSTEM

SUBMISSION NUMBER: DEN150010

DATE OF DE NOVO: MARCH 6, 2015

CONTACT: DIGNITANA AB C/O GLEN D. PARK, PHARMD TARGET HEALTH, INC. 261 MADISON AVENUE, 24TH FLOOR NEW YORK, NEW YORK 10016

#### REQUESTER'S RECOMMENDED CLASSIFICATION: II

#### INDICATIONS FOR USE

The DigniCap™ Scalp Cooling System is indicated to reduce the likelihood of chemotherapy induced alopecia in women with breast cancer.

#### LIMITATIONS

The sale, distribution, and use of DigniCap™ Scalp Cooling System are restricted to prescription use in accordance with 21 CFR 801.109.

Limitations on device use are also achieved through the following statements included in the instructions for use:

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### Contraindications:

"Contraindications are cold sensitivity, cold agglutinin disease, cryoglobulinemia and crvofibrinogenemia."

"Scalp cooling is contraindicated if chemotherapy is given with a curative intent in patients with hematological malignancies."

### Precautions / Warnings:

"Long-term effects of scalp-cooling and scalp metastasis have not been fully studied"

"Use of scalp cooling with taxanes plus anthracyclines when used together or in sequence has not been shown to be successful in preventing chemotherapeutic drug induced alopecia."

"Attention: Clinical studies have produced variable success rates in patient reduction of chemotherapy induced alopecia with scalp cooling since the outcome is dependent on several factors including chemotherapy regimen, dose, duration of drug infusion, chemotherapy drug metabolism, and concomitant comorbidities."

"Breast cancer patients treated with taxanes plus anthracyclines, when used together or in sequence, have not been shown to respond to scalp cooling for reducing chemotherapeutic drug induced alopecia. Dignicap® Scalp Cooling System should not be used in these patients."

PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.

## DEVICE DESCRIPTION

The Dignitana DigmiCap™ Scalp Cooling System consists of a computer controlled system that includes a refrigerated tank containing the cooling agent that is maintained at -8 ± 1 ℃. The liquid coolant circulates from the cooling unit to and through the channels of the cap and back to the cooling unit. The scalp temperature is monitored by three separate thermometers. Deviations from the pre-set temperature are automatically adjusted by the system (scalp temperature can be controlled with an accuracy of ±2.0℃).

The DigniCap™ Scalp Cooling System components include the following:

Digni C3 system - Is a refrigerator unit with an integral control system operated via a touch screen monitor and is capable of controlling two separate cooling caps independently of each other. Scalp cooling is performed in conjunction with a silicon inner cap (DigniCap™), an outer neoprene cap (DigniTherm™), and the liquid coolant (DigniCool™).

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DigniCap™ - A soft, tight-fitting silicon cap which has two separate cooling circuits, one for the front of the head and one for the back of the head plus a third sensor for overall safety control.

DigniCool™ - The liquid coolant monopropylene glycol (MPG5).

DigniTherm™ - The outer neoprene cap that insulates and keeps the inner cap in place. To improve cooling and ensure proper fitting, this cap is covers the DigniCap™ and includes a chin strap which is used to hold the cap in place. This neoprene cover cap, called the DigniTherm™, comes in different sizes and is colored coded to match the corresponding correct silicone Cooling Cap. In addition to acting as a means of maintaining cooling cap placement, this outer cap also provides insulation which improves cooling efficiency

DIGNISTICK™ – A component used to save data from a treatment or for troubleshooting when inserted in the slot. It can also be used to update software.

DIGNICARD™ – A key card which has to be inserted in order to start a treatment.

Image /page/2/Picture/5 description: The image shows a medical device and four cooling caps. The medical device is a cooling machine on wheels with a screen and a red helmet-like attachment. The four cooling caps are different colors: yellow, green, blue, and red. The caps are designed to be worn on the head and have straps to secure them in place.

Figure 1: DigniTherm™ and corresponding DigniCap™

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#### SUMMARY OF NONCLINICAL/BENCH STUDIES

#### BIOCOMPATIBILITY/MATERIALS

The only portion the system that comes into patient contact is the silicon DigniCap™. The DigniCap™ is a surface device that is in contact with the skin for a limited duration (<24h). The different color caps were subjected to cytotoxicity according to ISO 10993-5 and skin sensitization and irritation testing according to ISO 10993-10.

For cytotoxicity testing, the elution method was used with MRC-5 cells as the test article. All of the eluates from the DigniCap™ plus the negative control were found to be noncytotoxic.

Skin sensitization was tested using the mouse lymph node assay. For skin sensitization, extracts from each cap and cap color were applied to the dorsal surface of mice according to the ISO 10993-10 and compared to vehicle and positive control. Based on the test results none of the caps or cap colors was considered a potential skin sensitization material.

Skin irritation was tested using the rabbit model. Extracts of the cap and cap color material was placed on the rabbit under occlusion using polar and non-polar extracts. Based on the test results neither the polar or non-polar extract showed irritation effects thus the DigniCap™ material was determined not to be a skin irritant.

#### SHELF LIFE/STERILITY

This device is provided non-sterile which is appropriate for this patient population, as the cooling caps are used for cooling the scalp in a non-sterile environment. Cap cleaning between patient use involves cleaning using soap or alcohol and details to accomplish cleaning are provided in the labeling.

The manual provides instructions to the user to conduct a visual inspection of the DigniCap™. The cap should be inspected for any wear, tear, and leaks. If the DigniCap™ is damaged, it should be replaced.

Packaging and shipping testing of the device was conducted based on the ASTM standard D 4169-08 "Standard Practice for Performance Testing of Shipping Containers and Systems". This testing consists of placing the package into -25 ℃ conditions for 16 hours followed by 8 hours acclimation to room temperature and then placing the packaging into 50 ℃ conditions for 16 hours and then again returned to room temperature for 8 hours. Transportation testing includes simulated handling incidences such as being dropped from a forklift, damage from being moved by a crane, being dropped on a corner or dropped on a flat surface, being vibrated and receiving impacts from other items that may occurring in storage facilities. This testing demonstrated that the packaging was acceptable in terms of ensuring that the device can be shipped without damage using the proposed container system.

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### ELECTROMAGNETIC COMPATIBILITY (EMC) AND ELECTRICAL SAFETY

EMC testing was performed per the relevant requirements of IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests. Based on successful completion of the testing, the Dignitana DigniCap™ Scalp Cooling System is deemed compliant to the relevant requirements of IEC 60601-1-2:2007.

Electrical safety testing was performed per the relevant requirements of IEC 60601-1:2005, General safety standard: safety requirements for medical electrical systems. The Dignitana DigniCap™ Scalp Cooling System device passed all relevant portions of the testing and demonstrated the electrical safety for the Dignitana DigniCap™ Cooling System. Based on compliance with this standard, the Dignitana DigmiCap™ Cooling System can be considered to have established a reasonable assurance of electrical safety.

#### SOFTWARE

The DigniC3 system is comprised of a cooling subsystem, software, logic by electronics, and a user interface through a touch screen.

The software controls the cooling diverted to the patient by controlling the valves. This control is accomplished by sending a command on the communication BUS. An adaptation function handles the timing of the valves. The software control can be overridden by a hardware watchdog monitoring the lower bound of the temperature.

All of the elements of software information corresponding to moderate level of concern device as outlined in FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005) were provided. Adequate documentation describing the software development program was provided. Verification and validation (V&V) testing was conducted to address the potential hazards with satisfactory results. In addition, the software development procedures provide the foundation that the software will operate in a manner as described in the specifications. The software documentation is in sufficient detail to provide reasonable assurance that the software performs as intended and all software-related risks have been adequately mitigated.

#### PERFORMANCE TESTING - BENCH

Two separate verification studies were conducted to confirm that the temperature control mechanisms and safety features of the cooling system and cooling caps plus the software programing ensured proper circulating cooling temperatures in the cap. For the first study. dummy heads were developed to replicate the size of a human head. (b) (4)

| | | | | | | | A series of different test scenarios were conducted related to cap cooling depending on target cooling temperature. The specific temperatures tested were based on the recommended treatment settings in the User Manual, 3 °C and 5 °C. The 5 °C

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temperature is described as the default temperature and was used for most subjects and the 3 °C temperature is specifically identified for use with thick hair. The following test scenarios were evaluated:

- One cap connected to the system
- Two caps connected to system with both caps cooling at the same time
- Two caps connected with one cap cooling and a delayed start of the second cap ● cooling for several minutes.

These tests were evaluated by collection of temperature data (b) (4) during the total time of testing. Following the initial 20 minute cooling down period, the cap temperature remained stable for the 1 hour of test time for all of the different variations in cap use tested. The temperature measurements were made on scalp locations on the dummy heads thus representing what could be considered true scalp temperature.

In addition to performing the testing of the caps in their own laboratory, the sponor also had the caps tested by a private test company using a mock environmental set-up simulating environmental conditions of a hospital or healthcare facility. This testing included a variety of ambient room temperatures and humidity. The specific parameters tested were room t. The target cap temperature for these tests was 5 C. Similar to the testing above, results from the testing show that once the temperature has dropped during the 20 minute cool down time, the cap temperature remained stable for 60 minutes or longer depending on the test duration.

As part of testing of the system to verify that all of the safety features functioned to ensure cap cooling accuracy and consistency, tests related to the cooling system safety features such as tank filling and loss of fluid and over cooling (freezing of cooling solution) were conducted. These tests were included to demonstrate that system start-up time was accurate and that cap cool down times were maintained even if these safety features were engaged during actual cap cooling. Temperature graphs confirming correct operation in terms of cap cooling and maintenance of target temperature were provided. These tests duplicate actual treatment with the cooling cap in a simulated patient using head models. The testing included the total functioning of the total cooling system including proper functioning of the valve systems between tank and cap, the individual temperature sensors in the cap, and the temperature sensors in the tank related to low fluid volume and tank temperature below the safety limit.

Testing of coolant flow rates was not performed since the flowrate itself is not a critical parameter, and does not itself represent an independent hazardous situation. The critical parameter is the temperature of the cap. In order to maintain an appropriate temperature, coolant flow rate can vary depending on the temperature set for the DigmiCap™, ambient temperature, etc. Verification testing for proper and controlled cap cooling demonstrated that the system functions as designed, including the maintenance of appropriate coolant flow rates.

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## SUMMARY OF CLINICAL INFORMATION

Two human clinical studies using DigniCap™ demonstrated reasonably safe and effective use by verifying that the device reduces chemotherapy induced alopecia in breast cancer patients. The feasibility study conducted for this device is summarized in Table 3, and the pivotal study is summarized in Table 4, below.

| Study Title | Clinical Performance, Efficacy and Safety of the DigniCap™ Scalp Cooling<br>System, a Scalp Hypothermia System, in Preventing Chemotherapy Induced<br>Alopecia in Patients with Early Stage Breast Cancer | |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Study<br>Objective | To assess the feasibility of use of the DigniCap™ Scalp Cooling System in<br>patients with stage I breast cancer receiving adjuvant chemotherapy treatment<br>that, unless counteracted by simultaneous hypothermia treatment, results in ><br>75% hair loss by the completion of chemotherapy. | |
| Study<br>Endpoints | Primary endpoint:<br>To determine the feasibility of use of the DigniCap™ Scalp Cooling System in<br>this setting. Feasibility is defined as less than 50% of patients discontinuing use<br>of the cap due to cap associated patient toxicity.<br>Secondary endpoints:<br>1. Ability to complete protocol case report forms<br>2. Adverse events related to use of the DigniCap™ Scalp Cooling System<br>3. Hair loss assessment in women receiving specified chemotherapy regimens<br>using the DigniCap™ Scalp Cooling System with success was defined as <<br>grade 2 hair loss using the Deans scale. Considering both:<br>a. Patient assessment<br>b. Assessment by independent panel<br>4. Quality of life in women using the DigniCap™ Scalp Cooling System<br>5. Time to and quality of hair regrowth<br>6. Impact of hair loss on treatment decisions | |
| Sample Size | 20 subjects, 2 sites | |
| Inclusion/<br>Exclusion<br>criteria | Inclusion criteria:<br>1. Patient 18 years of age<br>2. Documented diagnosis of stage I breast cancer.<br>3. A planned course of chemotherapy in the adjuvant or neoadjuvant setting<br>including one of the following regimens:<br>- Doxorubicin 60 mg/m2 and Cyclophosphamide 600 mg/m2 x 4 - 6 cycles IV every 2 - 3 weeks<br>- Docetaxel 75 mg/m2 and Cyclophosphamide 600 mg/m2 x 4 - 6 cycles | |
| - | IV every 3 weeks | |
| - | Paclitaxel 80-90 mg/m2 weekly IV x at least 12 weeks with or without trastuzumab IV | |
| - | Paclitaxel 175 mg/m2 IV every 2 weeks x 4 – 6 cycles (without an anthracycline) | |
| - | Paclitaxel weekly and Carboplatin area under the curve (AUC) 2 weekly or AUC 6 every 3 weeks IV x 4 - 6 cycles and trastuzumab IV weekly or every 3 weeks. | |
| - | Docetaxel 75mg/m2, and Carboplatin AUC 6 IV every 3 weeks x 4 - 6 cycles and trastuzumab IV weekly or every 3 weeks. | |
| - | Targeted agents such as trastuzumab or lapatinib are allowed. | |
| 4. | Plan to complete chemotherapy within 6 months. | |
| 5. | At least two years out from the last chemotherapy causing hair loss with complete recovery of hair. | |
| 6. | Karnofsky performance status 70%<br>(i.e. cares for self; unable to carry on normal activity or to do active work). | |
| 7. | Willing and able to sign informed consent for protocol treatment, for authorized Sponsor representatives to be given access to the patient's hospital records for purposes of Source Data Verification, for photos taken before and after treatment, and for use of non-identifying information for purposes of publication | |
| 8. | Life expectancy 12 months | |
| 9. | Willing to be contacted in follow-up for at least 12 months. | |
| | | |
| <b>Exclusion criteria:</b> | | |
| 1. | Patients must not have female pattern baldness resembling picture I-3 or higher on the Savin scale. | |
| 2. | No autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss. | |
| 3. | No history of whole brain radiation. | |
| 4. | No plan to use a chemotherapy regimen other than those specified in section 7. Specifically, patients receiving a regimen including both an anthracycline and a taxane are not eligible for this trial: : Adriamycin, Cytoxan/taxotere (AC/T), Epirubicin/cyclophosphamide/ taxotere (EC/T), Taxotere/Adriamycin/cyclophosphamide (TAC), etc.. Patients may not receive concurrent hormone therapy; hormone therapy should be given as indicated following completion of chemotherapy. | |
| 5. | No serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned chemotherapy. | |
| 6. | No history of persistent grade 2 alopecia induced by prior chemotherapeutic regimens. | |
| 7. | No participation in any other clinical investigation or exposure to other investigational agents, drugs, device or procedure that may cause hair loss. | |
| 8. | No intercurrent life-threatening malignancy. | |
| 9. | No history of cold agglutinin disease, cryoglobulinemia or | |
| | 10. No evidence of untreated or poorly controlled hyper or hypothyroidism. | |
| | 11. No history of silicon allergy.<br>12. No evidence of abnormal liver function, defined as, aspartate | |
| | aminotransferase (AST) ≥ 3x upper limit of normal. | |
| | 13. No evidence of abnormal kidney function defined as creatinine ≥ 2X upper | |
| | limit of normal. | |
| | 14. American Society of Anesthesiologist Class ≥3. | |
| Procedure | Eligible patients included women diagnosed with stage1 breast cancer planning<br>to receive chemotherapy in the adjuvant or neo-adjuvant setting. 20 patients<br>were enrolled. The majority (80%) received docetaxel and cyclophosphamide<br>(TC) every three weeks for four to six doses. Other chemotherapy regimens<br>included 12 cycles of weekly paclitaxel with trastuzumab (10%), and docetaxel<br>and carboplatin with trastuzumab every three weeks for six cycles (10%).<br>Patients will receive scalp hypothermia as delivered by the DigniCap™ Scalp<br>Cooling System. Scalp cooling will begin 30 minutes prior to administration of<br>chemotherapy. Scalp temperature will be maintained at +3°C (37°F) throughout<br>drug administration and for 90-120 minutes after discontinuing the infusion,<br>depending on the chemotherapy regimen | |
| | | |
| Follow-up | Safety and tolerability in terms of adverse symptoms and adverse device effects<br>reported by patients during use of the DigniCapTM Scalp Cooling System and<br>during the follow-up period 3, 6 and 12 months after completion of treatment<br>was examined. | |
| Assessment<br>Tools | Photographic documentation was performed before initiation of the first cycle<br>of chemotherapy, before each subsequent cycle, at a visit 3 to 4 weeks after the<br>last cycle of chemotherapy. | |
| | Hair loss was assessed by an independent panel consisting of a hair dresser, a<br>patient advocate, and a dermatologist specializing in hair according to the Dean<br>Scale by review of photographs blinded to patient and sequence. | |
| | Patients evaluated their degree of hair loss at each visit according to the Dean<br>Scale without the review of photographs. | |
| | Quality of Life during and after chemotherapy was assessed by the patient using<br>the European Organization for Research and Treatment of Cancer (EORTC)<br>Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23) scale and the<br>Body Image Scale (BIS). | |
| | A Patient Symptom Survey was completed at each chemotherapy cycle. | |
| | | |
| Results | | |
| Patient | Evaluable patients for all follow-up visits = 19. | |
| Account- | | |
| ability | | |
| Results | Primary endpoint: | |
| | One patient out of the 20 evaluable patients discontinued study therapy due to<br>cap associated patient toxicity, patient assessed hair loss and severe anxiety. This<br>represents a 5% discontinuation rate and indicates that the scalp cooling system<br>is feasible in this setting. | |
| | Secondary endpoints | |
| | 1. Assessment of the ability to complete protocol case report forms<br>Patients completed a number of questionnaires throughout the study and<br>compliance was excellent | |
| | 2. Documentation of adverse events related to use of the DigniCap™ System | |
| | 2.1 Patient Reported Symptoms<br>Head Pain - 65% (13) of patients reported head pain during at least one<br>-<br>treatment<br>Chill - 80% (18) of patients experienced chill during treatment.<br>-<br>Scalp Pain - 95% (19) of patients reported scalp pain during at least one<br>-<br>treatment.<br>2.2 Use of Pain Medications During Treatment immediately before their<br>chemotherapy infusion and use of the DigniCap™ Scalp Cooling System<br>at some point during their treatment course<br>3 patients (15%) took non-prescription pain medication<br>-<br>11 patients (55%) took prescription pain medication<br>-<br>7 patients (35%) reported not using pain medication of any kind the<br>-<br>morning of their infusion with the DigniCap™ Scalp Cooling System<br>2.3 Practitioner reported specific cap-related adverse events.<br>No cases of metastasis, including metastasis to the scalp.<br>-<br>Adverse events (other than during time of actual cap use) were not related or<br>-<br>unlikely related to cap use. | |
| | 3. Hair loss assessment in women receiving specified chemotherapy<br>regimens using the DigniCap™ Scalp Cooling System including: | |
| | 3.1 Patient assessment<br>3.1.1. Assessment of physical hair loss according to the Deans scale.<br>Baseline mean grade on Deans scale = 0.15.<br>-<br>Halfway through treatment (N=20): 60% of patients reported <<br>-<br>grade 2 alopecia. The mean grade was 2.15.<br>One month after completion of chemotherapy (N=19): 58% of<br>- | |
| | patients reported < grade 2 alopecia. The mean grade was 2.21. | |
| - | Three months after completion of chemotherapy (N=17): 88% of patients reported < grade 2 alopecia. | |
| - | Overall 55% of patients never experienced > grade 2 alopecia throughout their entire treatment and follow-up. | |
| | 3.1.2. Assessment of quality of treatment response & quality of life. | |
| | 3.1.3. Assessment of the impact of hair loss on treatment decisions | |
| <b>3.2. Assessment by independent panel</b> |…