Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color: A Clinical and Mechanistic Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Severity of chemotherapy-induced alopecia
研究概览
简要总结
The purpose of this study is to evaluate hairstyling techniques aimed at increasing efficacy of scalp cooling in the prevention of chemotherapy-induced alopecia, determine scalp cooling effect on persistent chemotherapy-induced alopecia, and elucidate molecular mechanisms and predictive biomarkers associated with scalp cooling success in patients with skin of color receiving chemotherapy for breast or non-small cell lung cancer.
This study is being conducted because prior studies have found scalp cooling to be highly effective in preventing hair loss resulting from chemotherapy. However, minority representation was largely limited in completed trials. A recent study found that scalp cooling devices are less efficacious in patients with skin of color, likely because patients with skin of color have hair is predominantly types 3 (curly) and 4 (kinky), which tend to become bulkier when wet and can interfere with scalp cooling cap fitting. The investigators plan to test two techniques aimed at improving scalp cooling efficacy in patients with skin of color through hairstyling methods that minimize hair volume in order to increase cooling cap to scalp contact: 1) cornrows/braids/twists or 2) water/conditioner emulsion on hair. Preliminary data show that breast cancer patients with type 3 or 4 hair receiving taxane chemotherapy and scalp cooling using these techniques to prepare the hair for scalp cooling cap fitting all experienced hair preservation. Additionally, the investigators will also assess persistent chemotherapy-induced alopecia outcomes and incidence by following patients up to 6 months after completing treatment. Finally, specific gene expression changes in taxane-induced chemotherapy-induced alopecia in vitro have been described previously. The investigators will test the hypothesis that scalp cooling reverses such changes in chemotherapy-induced alopecia, assess for biomarkers predictive for scalp cooling success, and investigate persistent chemotherapy-induced alopecia molecular mechanisms using non-invasive transcriptome sequencing on plucked hair follicles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Hair counts using trichoscopy and photographs will be taken at baseline and at the beginning of each chemotherapy cycle, which will be graded by two independent clinicians blinded to the patient group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years
- •Hair type 3 (curly) or type 4 (kinky)
- •Diagnosis of breast cancer or non-small cell lung cancer (NSCLC) or gynecologic cancer stage I-IV
- •Patient will be starting >= 4 cycles of taxane-based chemotherapy treatment for curative intent after enrollment
- •a. Concurrent HER, cisplatin, cyclophosphamide therapies and doxorubicin therapies allowed
- •Eastern Cooperative Oncology Group (ECOG) 0-2: fully active, restrictive in physically strenuous activity, ambulatory and capable of self-care
排除标准
- •Hair type other than 3 or 4
- •Use of hair weave or extensions without plans to remove
- •Concurrent malignancy including hematologic malignancies (i.e. leukemia or lymphoma)
- •Alopecia Common Terminology Criteria for Adverse Events > grade 1 at baseline
- •Past chemotherapy administration if past treatment was <= 10 years ago
- •History of migraines or cluster headaches, anorexia, severe anemia, uncontrolled diabetes, hepatitis, thyroid dysfunction, cold urticaria, cold agglutinin disease, scalp metastases
- •Planned bone marrow ablation chemotherapy or skull irradiation
- •Pregnant patient
研究组 & 干预措施
Scalp cooling with hairstyle
Scalp cooling with hairstyle (braids, twists, cornrows) to minimize hair volume and increase scalp cooling cap to scalp contact
干预措施: Scalp cooling with hairstyle (Device)
Scalp Cooling with conditioner and water emulsion
Scalp cooling after coating hair with conditioner and water emulsion to minimize hair volume and increase scalp cooling cap to scalp contact
干预措施: Scalp cooling with conditioner and water emulsion (Device)
No Scalp Cooling
Control with no scalp cooling
结局指标
主要结局
Severity of chemotherapy-induced alopecia
时间窗: 6 months after completing treatment, up to approximately 11 months total (from the start to completion of chemotherapy)
The severity of chemotherapy-induced alopecia as determined by hair counts with trichoscopy with measurements of hair shaft diameter \& follicle density and Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) grading
Patient distress during treatment
时间窗: 6 months after completing treatment, up to approximately 11 months (from the start to completion of chemotherapy)
Assessed by the Chemotherapy Alopecia Distress Scale and patient self-assessment of hair growth using Common Terminology Criteria for Adverse Events
Severity of chemotherapy-induced alopecia - hair count density
时间窗: 4 weeks after completion of chemotherapy, up to ~6 months total
Severity of chemotherapy-induced alopecia, or CIA, as determined by hair count density from trichoscopy will be assessed. Hair count density (hair counts/cm\^2) will be summarized by study arm and analyzed using a T-test.
Severity of chemotherapy-induced alopecia - adverse events
时间窗: 4 weeks after the completion of chemotherapy, up to ~6 months total
Severity of CIA will also be evaluated based on Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) grading. Results will be summarized by study arm and analyzed Fisher's exact test.
次要结局
- Severity of persistent chemotherapy-induced alopecia(26 weeks (starting after chemotherapy completion))
- Patient distress after treatment(26 weeks (starting after chemotherapy completion))
- Severity of persistent chemotherapy-induced alopecia (PCIA) - hair count density(26 weeks after completion of chemotherapy, up to ~11 months total)
- Severity of persistent chemotherapy-induced alopecia - adverse events(26 weeks after completion of chemotherapy, up to ~11 months total)
- Patient distress after treatment(4 weeks, 8 weeks, 12 weeks, and 26 weeks after completion of chemotherapy, up to ~11 months total (from the start to completion of chemotherapy))