Cooling Cap Trial to Prevent Permanent Chemotherapy-induced Alopecia in Breast Cancer Patients

Sponsor

Samsung Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04678544

Collaborator

Paxman (Other)

170

Enrollment

Location

Arms

25.3

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to examine whether the PSCS2 is effective in reducing chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy. Female adults who are newly diagnosed with stage 1-3 breast cancer and expected to receive Adriamycin or/and Taxane will participate in the study. The study design is a open label, randomized controlled trial. The patients will be randomly assigned to intervention or control groups. Intervention patients will have applied scalp cooling during 4 or 6 cycles of their chemotherapy. Primary endpoint is the effectiveness of the PSCS2 for reducing permanent chemotherapy-induced alopecia. Secondary endpoints include chemotherapy-induced alopecia, distress due to chemotherapy induced alopecia, quality of life, and patient-reported alopecia related side effect.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm, Breast	Device: Scalp cooling system 2	N/A

Detailed Description

Adjuvant chemotherapy decreases the risk of recurrence. However, it has distressing side effects, including alopecia. Chemotherapy-induced alopecia (CIA) is a common and distressing side effect of many chemotherapy drugs. In previous study, more than half of the breast cancer patients experienced higher distress due to CIA during cancer treatment, and this distress was strongly associated with negative body image, overall health status, and psychosocial well-being. Recently scalp cooling has been known to be one of the effective options for hair loss prevention. However there was little information regarding the effect on prevention of permanent CIA(PCIA). This study aims to examine the impact of scalp cooling on prevention of PCIA as well as CIA.

Female adults who are newly diagnosed with stage 1-3 breast cancer and aged less than 70 years will be screened for plan of undergoing Adriamycin or/and Taxane regimen as neoadjuvant or adjuvant chemotherapy. Eligible patients will be randomly assigned to intervention or control groups (2:1 ratio). Patients in intervention group will have applied scalp cooling during 4 or 6 cycles of their chemotherapy whereas participants in control group will be observed.

The objective of the study is to examine whether Paxman scalp cooling system is effective in reducing PCIA in women with breast cancer undergoing neoadjuvant or adjuvant chemotherapy. In addition, impact of Paxman scalp cooling on prevention of CIA, alopecia-related distress, quality of life and patient-reported alopecia related side effect will be also explored.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Controlled Trial, Single centerRandomized Controlled Trial, Single center

Masking:

Single (Outcomes Assessor)

Masking Description:

There will be no blindness of physician and patients. However, statisticians who will analyze the data will be blinded.

Primary Purpose:

Prevention

Official Title:

A Randomized Controlled Trial to Evaluate Effectiveness of Cooling Cap to Prevent Permanent Chemotherapy-induced Alopecia Among Breast Cancer Patients

Actual Study Start Date :

Dec 23, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group Before the chemotherapy, patients in intervention group will use cooling cap 30 minutes before chemotherapy. Once chemotherapy drug be ready, patients will receive chemotherapy. After the chemotherapy, patients go to the cooling cap area (room) and wear the cooling cap additional 20 minute for Taxane and 90 minute for other drugs, respectively.	Device: Scalp cooling system 2 The investigational device which will be used in this study is the Paxman Scalp Cooling System 2. This device is manufactured by: Paxman Coolers Limited. This is a free-standing, electrically-powered, mobile refrigeration unit which circulates a refrigerated liquid coolant, at a pre-set temperature and flow rate, through a cooling cap which is attached to, and covers, the top of the patient's head. The Paxman Scalp Cooling System is intended to be used for scalp cooling of patients who are receiving chemotherapy for the treatment of solid tumors, in order to reduce the risk of chemotherapy-induced alopecia.
No Intervention: Controlled Group chemotherapy with usual care

Arm

Intervention/Treatment

Experimental: Intervention Group

Before the chemotherapy, patients in intervention group will use cooling cap 30 minutes before chemotherapy. Once chemotherapy drug be ready, patients will receive chemotherapy. After the chemotherapy, patients go to the cooling cap area (room) and wear the cooling cap additional 20 minute for Taxane and 90 minute for other drugs, respectively.

Device: Scalp cooling system 2

The investigational device which will be used in this study is the Paxman Scalp Cooling System 2. This device is manufactured by: Paxman Coolers Limited. This is a free-standing, electrically-powered, mobile refrigeration unit which circulates a refrigerated liquid coolant, at a pre-set temperature and flow rate, through a cooling cap which is attached to, and covers, the top of the patient's head. The Paxman Scalp Cooling System is intended to be used for scalp cooling of patients who are receiving chemotherapy for the treatment of solid tumors, in order to reduce the risk of chemotherapy-induced alopecia.

No Intervention: Controlled Group

chemotherapy with usual care

Outcome Measures

Primary Outcome Measures

Permanent chemotherapy-induced alopecia [6 months (±2 months) after completion of chemotherapy and intervention]
Permanent chemotherapy-induced alopecia is defined as hair density or thickness less than two standard deviations (SDs) compared to the baseline mean (before chemotherapy) at 6 months (±2 months) after completion of chemotherapy. Hair density and thickness will be measured by using Folliscope 5.0, LeadM.

Secondary Outcome Measures

Hair density and thickness during and after chemotherapy [Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention]
Hair density and thickness will be measured by using Folliscope 5.0, LeadM between 1st and 2nd intervention and at 1st clinical visit after chemotherapy compared to the baseline mean (before chemotherapy).
Distress due to chemotherapy-induced alopecia [Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention]
Chemotherapy-Induced Alopecia Distress Scale (CADS) will be used to demonstrate that the PSCS is effective in reducing distress due to chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy
Quality of life (cancer related quality of life) [Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention]
Quality of life will be measured using EORTC QLQ-C30. The QLQ-C30 is a cancer health-related quality-of-life questionnaire that has been widely used in clinical trials and investigations using patient reported outcome for individual patient management. It use a "past week" recall period. Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of Quality of life.
Breast cancer related quality of life [Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention]
Quality of life will be measured using EORTC QLQ-BR23. The BR23 is a breast cancer specific module to measure health-related quality-of-life . It use a "past week" recall period. Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of Quality of life.
Patients reported outcomes [Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention, and 6 months (±2 months) after completion of chemotherapy and intervention]
Self-reported hair loss will be assessed by using Korean version of PRO-CTCAE.
Global photographs [Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention, and 6 months (±2 months) after completion of chemotherapy and intervention]
Pictures to be focused on head/hair, which means shorter distance between the equipment and the subject by using Canon EOS 70D.

Other Outcome Measures

Side effect [At the beginning (1st day) of the 2nd cycle (each cycle is 21days), At the beginning of 3rd cycle of chemotherapy, At the beginning of 4th cycle of chemotherapy, At the beginning of 5th cycle of chemotherapy, and , At the beginning 6th of chemotherapy]
Potential side-effect including discomfort due to the cold, headache, dizziness or vomiting.
Willingness to pay [At the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy, and 6 months (±2 months) after completion of chemotherapy]
Willingness to pay to use scalp cooling by self-developed questionnaire.
Effort for managing hair [Baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), 1month (±2 weeks) after completion of chemotherapy and intervention, and 6 months (±2 months) after completion of chemotherapy]
Usual care for hair and scalp, type of shampoo, wig
Characteristic of participants [Smoking, drinking, medication and exposure-time to sunlight at baseline, at the beginning (1st day) of the 2nd cycle (each cycle is 21days), and 6m (±2m) after completion of chemotherapy, the others at only baseline]
Demographic information including age, education, marital status, working status, income, smoking and drinking history, medication, exposure-time to sunlight and co-morbidities

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 69 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Newly diagnosed breast cancer, stage I-III
Expected to receive 4 or 6 cycles of Adriamycin or Taxance of chemotherapy regimen as neoadjuvant or adjuvant chemotherapy with curative intent (e.g., AC, TC, or TCHP)

Exclusion Criteria:

Any other concurrent malignancy including hematological malignancies
Elevated liver enzymes or bilirubin defined as 3 times the upper limits of normal
Serum Albumin < 3.0
Subjects who are underweight (defined as a BMI < 17.5)
Subjects who have had previous chemotherapy exposure
Subjects with cold agglutinin disease or cold urticarial
Subject who had thyroid disease, diabetes or cardiac disease
Subject who had auto-immune disease
History of treatment due to alopecia
Subject who had scalp disease