A Study to Investigate Keratinocyte Growth Factor- Hair Serum for the Prevention of Chemotherapy Induced Alopecia
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Part 2: Randomized, placebo-controlled assessment of the efficacy of the investigational topical formula, KGF-HS measuring hair loss after chemotherapy.
研究概览
简要总结
Primary aim is to provide a preliminary assessment of the efficacy of the investigational topical formula, KGF-HS, as a prophylactic treatment for chemotherapy induced alopecia.
Hypothesis: KGF-HS will result in less than 50% hair loss by the end of 4 cycles of chemotherapy. The investigators will evaluate hair loss using the CTCAE (Common Terminology Criteria for Adverse Events) v4.0 alopecia grading scale.
详细描述
Primary specific aims
- To provide a preliminary assessment of the efficacy of the investigational topical formula, KGF-HS, as a prophylactic treatment for chemotherapy induced alopecia.
Hypothesis: KGF-HS will result in less than 50% hair loss by the end of 4 cycles of chemotherapy. The investigators will evaluate hair loss using the CTCAE (Common Terminology Criteria for Adverse Events) v4.0 alopecia grading scale.
Secondary specific aims 2. To estimate hair preservation as assessed by participant and physician. 3. To estimate participant reported comfort. 4. To evaluate quality of life. 5. To evaluate the incidence of adverse events for topical application. 6. To evaluate if topical hair serum results in faster hair growth after completion of chemotherapy in those who had grade 2 or higher alopecia while on chemotherapy 7. To evaluate responses to chemotherapy at time of surgery (for patients undergoing neoadjuvant chemotherapy (NAC))
Study Design: This study is a 2-part trial. For part 1 of the study, subjects will be enrolled into a prospective single arm phase where all of them get the study treatment. Investigators plan to enroll up to 25 subjects to have 20 evaluable subjects to this phase. At the end of 4 cycles of chemotherapy, primary efficacy end point data will be collected. After 20 evaluable subjects if ≥ 4 responses were noted, part 2 of the study will be activated. The decision rule is based on the lower bound of a one-sided 95% confidence interval; at least 4 out of 20 patients with response results in a lower bound greater than 5% success. The proportion with success and the lower bound of a one-sided exact confidence interval will be computed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with early stage breast cancer (stage I-III)
- •Scheduled but not begun, at least 4 cycles of taxane and/or anthracycline-based chemotherapy
- •≥ 21 years of age
- •Able to give informed consent
排除标准
- •Female pattern hair loss or hair loss disorder
- •Scalp folliculitis
- •Scalp psoriasis
- •Seborrheic dermatitis
- •Inflammatory scalp conditions such as lichen plano-pillaris
- •Subjects wearing wigs or subjects who shave their hair prior to chemotherapy
- •Unable to provide consent or make allotted clinical visits
- •Known allergy to KGF-HS being use in this study
研究组 & 干预措施
Part 1 - Initial group treatment
For part 1 of the study, subjects will be enrolled into a prospective single arm phase where all of them get the study treatment. We plan to enroll up to 25 subjects to have 20 evaluable subjects to this phase.
干预措施: Keratinocyte growth factor (Drug)
结局指标
主要结局
Part 2: Randomized, placebo-controlled assessment of the efficacy of the investigational topical formula, KGF-HS measuring hair loss after chemotherapy.
时间窗: Four months
To provide a preliminary assessment of the efficacy of the investigational topical formula, KGF-HS, as a prophylactic treatment for chemotherapy induced alopecia. Hypothesis: KGF-HS will result in less than 50% hair loss by the end of 4 cycles of chemotherapy. We will evaluate hair loss using the CTCAE (Common Terminology Criteria for Adverse Events) v4.0 alopecia grading scale: Grade 1 = Hair loss of \<50% of normal; Grade 2 = Hair loss of \>50% of normal.
Part 1: Preliminary assessment of the efficacy of the investigational topical formula, KGF-HS measuring hair loss after chemotherapy.
时间窗: Four months
Hypothesis: KGF-HS will result in less than 50% hair loss by the end of 4 cycles of chemotherapy. We will evaluate hair loss using the CTCAE (Common Terminology Criteria for Adverse Events) v4.0 alopecia grading scale: Grade 1 = Hair loss of \<50% of normal; Grade 2 = Hair loss of \>50% of normal.
次要结局
- Hair preservation as assessed by physician.(Four months)
- Estimate participant reported comfort.(Four months)
- Evaluate quality of life using BIS.(Four months)
- Hair preservation as assessed by participant.(Four months)
- Evaluate the incidence of adverse events for topical application.(Four months)
- Evaluate responses to chemotherapy at time of surgery.(Four months)
- Evaluate quality of life using EORTC QLQ-C30(Four months)
- Evaluate quality of life using HADS.(Four months)
- Evaluate hair regrowth.(Four months)