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

NCT04678544 | Completed DMC FDA Device

• 1 other identifier: PAXMAN
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine whether the PSCS2 is effective in reducing chemotherapy-induced alopecia in women 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/Taxane will participate in the study. The study design is an 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. The 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 effects. After the RCT, only patients who were expected to receive 4, 6, or 8 cycles of chemotherapy with an anthracycline regimen were further enrolled in the intervention group as a single-arm trial.

Conditions

Neoplasm, Breast

Keywords

Scalp cooling system; Randomized controlled trial; Permanent-Chemotherapy-Induced Alopecia; Chemotherapy-Induced Alopecia

Outcome Measures

Primary Outcomes (1)

• Permanent chemotherapy-induced alopecia

  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.

  6 months (±2 months) after completion of chemotherapy and intervention

Secondary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (4)

• 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

• 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

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Controlled Group

NO INTERVENTION

chemotherapy with usual care

Interventions

Scalp cooling system 2 DEVICE

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. After the RCT, 34 patients who were expected to receive 4, 6, or 8 cycles of chemotherapy with an anthracycline regimen were further enrolled in the intervention group as a single-arm trial.

Intervention Group

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• For the additional single arm, patients who expected to receive 4, 6, or 8 cycles of Adriamycin or Taxance chemotherapy regimen as neoadjuvant or adjuvant chemotherapy with curative intent (e.g., AC, TC, TCHP, or AC+T).

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Paxman: collaborator

Study Sites (1)

Samsung Medical Center, Ilwon-ro 81, Gangnam-gu

Seoul, 06351, South Korea

Location

Related Publications (23)

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• Dunnill CJ, Al-Tameemi W, Collett A, Haslam IS, Georgopoulos NT. A Clinical and Biological Guide for Understanding Chemotherapy-Induced Alopecia and Its Prevention. Oncologist. 2018 Jan;23(1):84-96. doi: 10.1634/theoncologist.2017-0263. Epub 2017 Sep 26.

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• Rugo HS, Klein P, Melin SA, Hurvitz SA, Melisko ME, Moore A, Park G, Mitchel J, Bageman E, D'Agostino RB Jr, Ver Hoeve ES, Esserman L, Cigler T. Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer. JAMA. 2017 Feb 14;317(6):606-614. doi: 10.1001/jama.2016.21038.

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• Kang D, Cho J, Zhao D, Kim J, Kim N, Kim H, Kim S, Kim JY, Park YH, Im YH, Guallar E, Ahn JS. Scalp Cooling in Preventing Persistent Chemotherapy-Induced Alopecia: A Randomized Controlled Trial. J Clin Oncol. 2024 Sep 10;42(26):3115-3122. doi: 10.1200/JCO.23.02374. Epub 2024 Jun 6.

  PMID: 38843479 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jin Seok Ahn, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: There will be no blindness of physician and patients. However, statisticians who will analyze the data will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized Controlled Trial, Single center

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 22, 2020
• Study Start: December 23, 2020
• Primary Completion: August 27, 2021
• Study Completion: August 30, 2022
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Requests for study protocol and informed consent form can be shared after starting recruit. Requests for deidentified individual participant data can be made beginning 24 months after publication and for up to 36 months post publication.
• Access Criteria: People who send a request e-mail and be received confirmation from : jinseok.ahn@samsung.com or jcho@skku.edu

Locations

KR (1)