- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02605629
EValuation of the Impact of a TOpical Lotion on Permanent Chemotherapy Induced Hair Disorders in Cancer Survivors (VOLUME)
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)
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 135-710
- Danbee Kang
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CG428
Patients will self-administer the study product twice per day (morning, evening) for 6 months, for the efficacy assessment
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The experimental group will receive CG428.
For each application, the patient should shake the bottle before spraying 10-12 times directly to the dry scalp whole area, with the nozzle, and then gently massage the whole scalp with fingertips in order to spread the lotion evenly until it has completely penetrated the scalp.
Hairs should not be washed or shampooed within 1 hour following study treatment administration.
Each dose should be spaced out by minimum 4 hours.
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Placebo Comparator: Placebo
Patients will self-administer the study placebo twice per day (morning, evening) for 6 months, for the efficacy assessment
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The placebo group will received placebo which excluded active ingredients.
For each application, the patient should shake the bottle before spraying 10-12 times directly to the dry scalp whole area, with the nozzle, and then gently massage the whole scalp with fingertips in order to spread the lotion evenly until it has completely penetrated the scalp.
Hairs should not be washed or shampooed within 1 hour following study treatment administration.
Each dose should be spaced out by minimum 4 hours.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recovery rate of hair thickness 6 months after intervention Using Folliscope 4.0, LeadM
Time Frame: 6 months after randomization
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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.
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6 months after randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global photographs
Time Frame: All time (baseline, 3month and 6 months after intervention)
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Pictures to be focused on head/hair, which means shorter distance between the equipment and the subject using Canon EOS 70D
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All time (baseline, 3month and 6 months after intervention)
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Hair condition
Time Frame: All time (baseline, 3month and 6 months after intervention)
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Outcomes will be collected using objective methods and patient reported outcomes: Objectively quantified: Hair thickness and density: We will measure hair thickness and density using Folliscope 4.0, LeadM We will take a picture on the parietal (To around 2 cm) and then analysis using Folliscope program. Global photographs: Pictures to be focused on head/hair, which means shorter distance between the equipment and the subject |
All time (baseline, 3month and 6 months after intervention)
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Chemotherapy-induced alopecia distress Stress Using Chemotherapy induced alopecia distress scale (CADS)
Time Frame: 6 months after randomization
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Respondents will be instructed to indicate on a 4-point Likert scale on each statement (1=Not at all, 2= A little, 3=Quite a bit, 4=Very much).
Total scores will be calculated by summing responses for all items; higher scores means more distress due to CIA
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6 months after randomization
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Scalp skin water levels
Time Frame: All time (baseline, 3month and 6 months after intervention)
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Water on scalp: it will be measured using Corneometer (Courage-Khazakaelectronic GmbH, Germany).
We will measure 3 times on same area
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All time (baseline, 3month and 6 months after intervention)
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Sebum on scalp
Time Frame: All time (baseline, 3month and 6 months after intervention)
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it will be measured using Sebumeter SM815 (Courage-Khazakaelectronic GmbH, Germany).
We will measure 1 times on same area
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All time (baseline, 3month and 6 months after intervention)
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Overall hair and scalp condition
Time Frame: All time (baseline, 3month and 6 months after intervention)
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Patient self-assessment: We will measure patient reported hair density and thickness, scalp condition, and density using visual analogue scale (VAS) ranging from 0 to 10
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All time (baseline, 3month and 6 months after intervention)
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Nail condition
Time Frame: All time (baseline, 3month and 6 months after intervention)
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Patient self-assessment: We will use self-reported questionnaire using visual analogue scale (VAS) ranging from 0 to 10. Global photographs: We will take a picture the patients' nail using Canon EOS 70D with Intelli-Flash system or similar system |
All time (baseline, 3month and 6 months after intervention)
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Quality of life at the time
Time Frame: All time (baseline, 3month and 6 months after intervention)
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We will assess patients' body image using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 and breast specific module
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All time (baseline, 3month and 6 months after intervention)
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Depression
Time Frame: All time (baseline, 3month and 6 months after intervention)
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We will assess patients' depression using Hospital Anxiety and Depression Scale (HADS).
It consists of 14 items in two domains (Depression and anxiety).
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All time (baseline, 3month and 6 months after intervention)
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Anxiety
Time Frame: All time (baseline, 3month and 6 months after intervention)
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We will assess patients' anxiety using Hospital Anxiety and Depression Scale (HADS).
It consists of 14 items in two domains (Depression and anxiety).
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All time (baseline, 3month and 6 months after intervention)
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Satisfaction with products
Time Frame: After intervention (3month and 6 months after intervention)
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We will use self-reported questionnaire for satisfaction with the products as well as suggestions for improvement after completion of study with patients who received the CG428.
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After intervention (3month and 6 months after intervention)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effort for managing hair
Time Frame: All time (baseline, 3month and 6 months after intervention)
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Effort for managing hair using a questionniare whcih developed by researcher
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All time (baseline, 3month and 6 months after intervention)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Juhee Cho, PhD, Samsung Medical Center
Publications and helpful links
General Publications
- Choi EK, Kim IR, Chang O, Kang D, Nam SJ, Lee JE, Lee SK, Im YH, Park YH, Yang JH, Cho J. Impact of chemotherapy-induced alopecia distress on body image, psychosocial well-being, and depression in breast cancer patients. Psychooncology. 2014 Oct;23(10):1103-10. doi: 10.1002/pon.3531. Epub 2014 Mar 24.
- Kim IR, Cho J, Choi EK, Kwon IG, Sung YH, Lee JE, Nam SJ, Yang JH. Perception, attitudes, preparedness and experience of chemotherapy-induced alopecia among breast cancer patients: a qualitative study. Asian Pac J Cancer Prev. 2012;13(4):1383-8. doi: 10.7314/apjcp.2012.13.4.1383.
- Kang D, Kim IR, Im YH, Park YH, Ahn JS, Lee JE, Nam SJ, Park H, Kim E, Lee HK, Lee DY, Cho J. Quantitative changes in skin composition parameters due to chemotherapy in breast cancer patients: a cohort study. Breast Cancer Res Treat. 2015 Aug;152(3):675-82. doi: 10.1007/s10549-015-3502-4. Epub 2015 Jul 22.
- Kondo R et al.,Assessment of the Efficacy of CG 428 in the Recovery from Chemotherapy Long Term Side Effects on Hair in Women (an open label evaluation), Legacy Healthcare Japan, 2013
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VOLUME
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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