Evaluation of the Impact of a Topical Lotion, CG428, on Permanent Chemotherapy Induced Hair and Scalp Disorders in Cancer Survivors: An Open-label 6 Months Extension of VOLUME Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Hair thickness
研究概览
简要总结
We would suggest to conduct "VOLUME-2" study, as an extension of the ongoing "VOLUME" study with all subjects already included. After completion of VOLUME study, the study will be directly extend with an "open-label design". All participants, who agreed to pursue, with either "Placebo" or "CG428", will receive CG428 treatment for an additional six-month period. VOLUME-2 study would be ideal and timely by enabling no interruption of product use.
The Primary Objective is to observe for a longer period the efficacy of CG428 (12 months : 6months Volume + 6 months Volume-2) in order to better discriminate later or non-responder populations.
Secondary Objectives are :
- Evaluate how far CG428 can improve hair-pattern (reach a plateau or constant progression)
- Evaluate motivation and adherence of subjects
- Long term safety
详细描述
The research team at Cancer Education Center at Samsung Comprehensive Cancer Center has studied CIA and its impact on distress and psychosocial well-being since 2008. We found that 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. In a recent prospective cohort study, we assessed skin and hair change patterns before, during and 6 months after chemotherapy in 61 volunteers.
We found that the majority of the patients still experienced CIA at 6 months after completion of chemotherapy. Actually, hair diameter at 6th month after chemotherapy had not recovered to baseline level. Permanent chemotherapy-induced alopecia, defined as absent or incomplete hair regrowth at ≥6 months post-chemotherapy, was reported from 53 to 74%. Like CIA, permanent CIA also lacks recognition and has been underserved regardless of patients' needs. The first botanical blend Legacy Healthcare developed and patented is Cellium. Cellium is composed of 4 botanicals (Allium cepa L., Citrus limon L., Theobroma cacao L., Paullinia cupana).
The first product derived from Cellium is a topical lotion for male and female alopecia, CG210. Based on the safety and efficacy data, the EMA (European Medicines Agency) has considered CG210 eligible for a European centralized herbal medicine registration. CG428 is the second product derived from Cellium. CG428 contains the exact same ingredients as CG210, in a different dosage. Legacy Healthcare have conducted a pilot studies with CG428 in Japan. The trial included female cancer survivors experiencing permanent/persistent CIA for more than 12.
Based on the results, several cancer treatment centers in Japan have started to recommend the product on a compassionate basis.We therefore hypothesize that the investigated topical lotion may mitigate the impact of protracted or permanent CIA in cancer survivors by restoring a normalized apoptotic process of hair follicular cells and reducing the acute, as well as chronic inflammation in the scalp, two issues that may remain unsettled following anticancer treatment. While considering the subjects included in the "VOLUME" study, it appears that a majority of cancer survivors did not recover a full hair pattern even 3 years after cancer treatment. This is per se an interesting data, and a new and significant knowledge revealing that persistent chemotherapy induced apopecia (CIA) is more common than anticipated.
While considering the subjects included in the "VOLUME" study, it appears that a majority of cancer survivors did not recover a full hair pattern even 3 years after cancer treatment. This is per se an interesting data, and a new and significant knowledge revealing that persistent chemotherapy induced apopecia (CIA) is more common than anticipated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •hair parameters obtained before the start of chemotherapy
- •Patients who participated in VOLUME
- •Able to keep their hair style
- •Able to use the study treatment in compliance with the protocol.
- •Physical (ECOG≤1) and psychological ability to participate
排除标准
- •Concomitant use of other anti-hair-loss treatment or hair growth treatment.
- •Patients with recent hair transplants or who plan to have transplants.
- •Known allergy or hypersensitivity to some components of CG428 (including allium cepa (onion), citrus, caffeine, theobromine)
- •Pre-existing alopecia or significant scalp disease, which may alter study treatment administration or absorption.
结局指标
主要结局
Hair thickness
时间窗: 6 months after intervention
Objectively quantified hair thickness will measure using Folliscope 4.0, LeadM
次要结局
- Chemotherapy-induced alopecia distress Stress Using Chemotherapy induced(All time (baseline, 3month and 6 months after intervention))
- Global photographs(All time (baseline, 3month and 6 months after intervention))
- Satisfaction with products(All time (baseline, 3month and 6 months after intervention))
- Overall hair and scalp condition(All time (baseline, 3month and 6 months after intervention))
- Nail condition(All time (baseline, 3month and 6 months after intervention))
- Quality of life at the time(All time (baseline, 3month and 6 months after intervention))
- Willing to Pay(6 months after intervention)
- Hair condition(All time (baseline, 3month and 6 months after intervention))
研究者
Juhee Cho
Chair, Assistant Professor Department of Clinical Research Design & Evaluation, SAIHST
Samsung Medical Center