A Randomized Controlled Trial to Evaluate Effectiveness of Cooling Cap to Prevent Permanent Chemotherapy-induced Alopecia Among Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Permanent chemotherapy-induced alopecia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
There will be no blindness of physician and patients. However, statisticians who will analyze the data will be blinded.
入排标准
- 年龄范围
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Permanent chemotherapy-induced alopecia
时间窗: 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.
次要结局
- 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 (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)
- 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)
- 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)
- 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)
- 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)
研究者
Jin Seok Ahn, MD
Professor
Samsung Medical Center