EValuation of the Impact of a TOpical Lotion, CG428, on Permanent Chemotherapy Induced Hair and Scalp Disorders in Cancer SUrvivors: A randoMized, Single-center, Double-blind placEbo Controlled Trial (a Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Recovery rate of hair thickness 6 months after intervention Using Folliscope 4.0, LeadM
研究概览
简要总结
This study aims to evaluate the Impact of a topical Lotion, CG428, on permanent chemotherapy induced hair and scalp disorders in Cancer survivors. This is a double-blind, single center, randomized, controlled trial in breast cancer survivors.
Hair condition and parameters of 61 breast cancer survivors who were previously included in DERMA study (a prospective cohort study to assess appearance changes due to breast cancer treatment completed in July, 13th,2013) will be assessed.
- Patients whose hair parameters are below the baseline as measured before the start of the chemotherapy or
- who complain from incomplete hair regrowth will be eligible to participate in the randomized controlled trial.
Patients who agree to participant in the study will be randomly assigned to two parallel arms (Arm 1: CG428/ Arm 2: Placebo). Patients will self-administer the study product or placebo twice per day (morning, evening) for 6 months, for the efficacy assessment.
Primary endpoint was recovery of hair thickness 6 months after intervention as assessed using Folliscope 4.0.
Secondary endpoints included hair density at 6 months after intervention, distress due to chemotherapy induced alopecia, scalp skin parameters (water and sebum). Patient-reported hair quality improvement, body image and quality of life, and time to first visible improvement based on global photographs of hair and nails.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •hair parameters obtained 6 months after the completion of chemotherapy
- •whose hair parameters are below the baseline, as measured before the start of chemotherapy during DERMA study, or
- •who complain from incomplete hair regrowth at the time of enrollment (on average 24 months after chemotherapy completion)
- •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, the obromine)
- •Pre-existing alopecia or significant scalp disease, which may alter study treatment administration or absorption.
研究组 & 干预措施
Placebo
Patients will self-administer the study placebo twice per day (morning, evening) for 6 months, for the efficacy assessment
干预措施: Placebo (Other)
CG428
Patients will self-administer the study product twice per day (morning, evening) for 6 months, for the efficacy assessment
干预措施: CG428 (Other)
结局指标
主要结局
Recovery rate of hair thickness 6 months after intervention Using Folliscope 4.0, LeadM
时间窗: 6 months after randomization
Objectively quantified hair thickness will measure using Folliscope 4.0, LeadM We will take a picture of 15X and 60X on the parietal (To around 2 cm) and then analysis using Folliscope program.
次要结局
- Scalp skin water levels(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))
- Chemotherapy-induced alopecia distress Stress Using Chemotherapy induced alopecia distress scale (CADS)(6 months after randomization)
- Global photographs(All time (baseline, 3month and 6 months after intervention))
- Anxiety(All time (baseline, 3month and 6 months after intervention))
- Depression(All time (baseline, 3month and 6 months after intervention))
- Satisfaction with products(After intervention (3month and 6 months after intervention))
- Hair condition(All time (baseline, 3month and 6 months after intervention))
- Sebum on scalp(All time (baseline, 3month and 6 months after intervention))
- Overall hair and scalp condition(All time (baseline, 3month and 6 months after intervention))
研究者
Juhee Cho
Cancer Education Center
Samsung Medical Center