A Phase 2 Study to Assess the Safety and Efficacy of Scalp Cooling Using PenguinTM Cold Caps for the Prevention or Reduction of Chemotherapy-induced Alopecia in Stage I-III Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Deans Alopecia Scale
研究概览
简要总结
The goal of this study is to estimate the efficacy of Penguin cold caps in preventing or reducing hair loss in patients receiving (neo)adjuvant chemotherapy (one of four common regimens) for early stage breast cancer.
详细描述
This will be a phase II prospective, open label, non-randomized study conducted to determine the safety and efficacy of Penguin TM cold cap system in preventing or reducing chemotherapy-induced alopecia in patients with early stage breast cancer undergoing chemotherapy.
Eligible subjects will be enrolled to one of 4 study arms determined by type of chemotherapy. Subjects will have early stage breast cancer of any receptor subtype, for which standard of care includes chemotherapy. Eligible subjects will be enrolled at Providence Portland Medical Center (PPMC) and Providence St. Vincent Medical Center (PSVMC).
The PenguinTM cold cap therapy will be administered to all enrolled subjects according to the dosing schedule specified by the study arms. PenguinTM cold caps is a portable scalp cooling system which uses gel-filled cold caps that are cooled on dry ice and exchanged every 30 minutes in order to maintain optimum temperature. Its unique crylon gel formula is specifically created to maintain cold temperatures for much longer periods of time than other conventional cooling gels and foams. No scalp preparation is required before use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •At least ≥ 18 years of age
- •Diagnosis of stage I-III breast cancer for whom neoadjuvant or adjuvant cytotoxic chemotherapy (ACT/HP, TCH/P, TC, or T/H) is planned.
- •Willing and able to provide informed consent.
- •Availability of caretaker(s) to accompany participant and facilitate cold-cap placement/exchanges using the recommended technique.
- •Women of childbearing potential must use acceptable measures to avoid becoming pregnant during study period and for 30 days after last dose of chemotherapy.
排除标准
- •Pre-existing alopecia (Dean's scale ≥ 1)
- •Another malignancy that required active treatment with systemic chemotherapy within 2 years of study recruitment.
- •Prior radiotherapy treatment involving head.
- •Pre-existing chronic severe headaches or migraines.
- •Skin conditions that in the opinion of PI would be at risk of worsening with study.
- •Cold sensitivity or cold agglutinin disease
- •Cryoglobulinemia
- •Cryofibrogenemia
- •History of current evidence of any condition, therapy or abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, such that trial participation is not in the best interest of the subject.
研究组 & 干预措施
Penguin Cold Caps
Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy.
干预措施: Penguin Cold Caps (Device)
结局指标
主要结局
Deans Alopecia Scale
时间窗: 30 days post chemotherapy treatment
Number of patients who score from 0-2 on Deans Alopecia Scale
Efficacy of PenguinTM Cold-caps for Prevention or Reduction of CIA
时间窗: 30 days post chemotherapy treatment
Efficacy will be reported as the proportion of evaluable subjects in each arm who achieve a score of 0-2 on the Dean's alopecia scale (i.e. less than 50% hair loss by standardized photography) at the 30-day post-chemotherapy assessment visit. A modified intention-to-treat (ITT) analysis will be followed whereby all subjects receiving at least 75% of prescribed chemotherapy dose will be considered evaluable (those receiving less chemotherapy are excluded to minimize confounding effect of chemotherapy dose). Subjects who withdraw consent prior to efficacy assessment will constitute treatment failures according to the intention-to-treat principle. Dean's alopecia scale is as follows: Grade 0 indicates no hair loss, Grade 1 indicates up to 25% hair loss, Grade 2 indicates greater than 25% hair loss up to 50% hair loss, Grade 3 indicates greater than 50% hair loss up to 75% hair loss, and Grade 4 indicates greater than 75% hair loss.
次要结局
- Was it Worth it Questionnaire(30 days post chemotherapy treatment)
- Common Terminology Criteria for Adverse Events (CTCAE) v4.0(30 days post chemotherapy treatment)
- European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30(30 days post chemotherapy treatment)
- Body Image Scale Questionnaire(30 days post chemotherapy treatment)
- "Was It Worth It?" Questionnaire Exit Interview(30 days post chemotherapy treatment)
- EORTC QLQ-C30 Exit Interview(30 days post chemotherapy treatment)
- BR23 Exit Interview(30 days post chemotherapy)