Cooling Cap Trial to Prevent Permanent Chemotherapy-induced Alopecia in Breast Cancer Patients
- Conditions
- Neoplasm, Breast
- Interventions
- Device: Scalp cooling system 2
- Registration Number
- NCT04678544
- Lead Sponsor
- Samsung Medical Center
- 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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 170
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Scalp cooling system 2 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
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.
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
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.
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).
Trial Locations
- Locations (1)
Samsung Medical Center, Ilwon-ro 81, Gangnam-gu
🇰🇷Seoul, Korea, Republic of