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Completed

NCT Number: NCT04678544

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

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.

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Key information

Conditions

Neoplasm, Breast Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 06351, South Korea

About this study

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 a 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 the prevention of permanent CIA(PCIA). This study aims to examine the impact of scalp cooling on the 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 a 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 the intervention group will have applied scalp cooling during 4 or 6 cycles of their chemotherapy whereas participants in the control group will be observed.

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

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • 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).

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

Treatment and study plan

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.

Primary outcomes

  1. Permanent chemotherapy-induced alopecia

    Time frame: 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 outcomes

  1. Hair density and thickness during and after chemotherapy

    Time frame: 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).

  2. Distress due to chemotherapy-induced alopecia

    Time frame: 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

  3. Quality of life (cancer related quality of life)

    Time frame: 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.

  4. Breast cancer related quality of life

    Time frame: 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.

  5. Patients reported outcomes

    Time frame: 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.

  6. Global photographs

    Time frame: 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 outcomes

  1. Side effect

    Time frame: 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.

  2. Willingness to pay

    Time frame: 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.

  3. Effort for managing hair

    Time frame: 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

  4. Characteristic of participants

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Paxman

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 22, 2020
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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