A 6-month Post-interventional Follow-up Extension of VOLUME Study (VOLUME-2) (VOLUME2)
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|ClinicalTrials.gov Identifier: NCT02986412|
Recruitment Status : Completed
First Posted : December 8, 2016
Last Update Posted : September 4, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Alopecia Chemotherapy Effects||Other: CG428||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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.|
|Actual Study Start Date :||January 15, 2016|
|Actual Primary Completion Date :||December 15, 2016|
|Actual Study Completion Date :||December 15, 2017|
Patients will self-administer the study product twice per day (morning, evening) for 6 months, for the efficacy assessment
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.
- Hair thickness [ Time Frame: 6 months after intervention ]Objectively quantified hair thickness will measure using Folliscope 4.0, LeadM
- Chemotherapy-induced alopecia distress Stress Using Chemotherapy induced [ Time Frame: All time (baseline, 3month and 6 months after intervention) ]Respondents will be instructed to indicate on a 4-point Likert scale on each
- Global photographs [ Time Frame: All time (baseline, 3month and 6 months after intervention) ]Pictures to be focused on head/hair, which means shorter distance between the equipment and the subject using Canon EOS 70D
- Overall hair and scalp condition [ Time Frame: All time (baseline, 3month and 6 months after intervention) ]Patient self-assessment: We will use self-reported questionnaire using visual analogue scale (VAS) ranging from 0 to 10.
- Nail condition [ Time Frame: All time (baseline, 3month and 6 months after intervention) ]Patient self-assessment: We will use self-reported questionnaire using visual analogue scale (VAS) ranging from 0 to 10.
- Quality of life at the time [ Time Frame: All time (baseline, 3month and 6 months after intervention) ]European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 and breast specific module
- Satisfaction with products [ Time Frame: All time (baseline, 3month and 6 months after intervention) ]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.
- Willing to Pay [ Time Frame: 6 months after intervention ]We will ask how much to willing to pay for CG428
- Hair condition [ Time Frame: All time (baseline, 3month and 6 months after intervention) ]
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
- Group in VOLUME [ Time Frame: At baseline ]Information about what group they belonged to in previous studies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986412
|Korea, Republic of|
|Seoul, Korea, Republic of, 135-710|
|Principal Investigator:||Juhee Cho, PhD||Samsung Medical Center|