AlopeciaVOLUME2NCT02986412
A 6-month Post-interventional Follow-up Extension of VOLUME Study (VOLUME-2)
A study testing CG428 in people with Alopecia and Chemotherapy Effects, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
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". Read more about this study
- Who is it for?
- Ages 19 to 70 years, women only
- Conditions the study is for
- Alopecia, Chemotherapy Effects
- What is being tested?
- CG428
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jan 2016to 15 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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
Read the detailed description
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.
The "VOLUME" study could have in fact two major repercussions: in addition to give information on CG428 efficacy, it will help to better define persistent CIA and improve thereby our scientific knowledge of this condition. Considering the high prevalence and poor literature on persistent CIA, it appears important to study this condition further.
To this end, we would suggest to conduct "VOLUME-2" study, as an extension of the ongoing "VOLUME" study with all subjects already included.
This study aims to evaluation of Longer observation (12 months : 6months Volume + 6 months Volume-2) permitting to better discriminate later or non-responder populations.
This is a open-label, single center, observation study in breast cancer survivors of VOLUME participants.
Hair condition and parameters of 31 breast cancer survivors who were previously included in VOLUME study (a randomized controlled trial to evaluate effect of CG428 which is topical hair lotion for chemotherapy induced alopecia completed in December, 2016) will be assessed.
The participation du extension Volume-2 study will be proposed to patients during the last visit of Volume study (Month 6)
The "VOLUME" study could have in fact two major repercussions: in addition to give information on CG428 efficacy, it will help to better define persistent CIA and improve thereby our scientific knowledge of this condition. Considering the high prevalence and poor literature on persistent CIA, it appears important to study this condition further.
To this end, we would suggest to conduct "VOLUME-2" study, as an extension of the ongoing "VOLUME" study with all subjects already included.
This study aims to evaluation of Longer observation (12 months : 6months Volume + 6 months Volume-2) permitting to better discriminate later or non-responder populations.
- Conditions
- Alopecia, Chemotherapy Effects
- Being tested
- CG428
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG428Other
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.
| Study group | Role | What they receive |
|---|---|---|
| CG428 | Experimental | Patients will self-administer the study product twice per day (morning, evening) for 6 months, for the efficacy assessment Receives: Other: CG428 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair thickness
Objectively quantified hair thickness will measure using Folliscope 4.0, LeadM
Measured: 6 months after intervention
Secondary outcomes (8)
Chemotherapy-induced alopecia distress Stress Using Chemotherapy induced
Respondents will be instructed to indicate on a 4-point Likert scale on each
Measured: All time (baseline, 3month and 6 months after intervention)
Global photographs
Pictures to be focused on head/hair, which means shorter distance between the equipment and the subject using Canon EOS 70D
Measured: All time (baseline, 3month and 6 months after intervention)
Overall hair and scalp condition
Patient self-assessment: We will use self-reported questionnaire using visual analogue scale (VAS) ranging from 0 to 10.
Measured: All time (baseline, 3month and 6 months after intervention)
Nail condition
Patient self-assessment: We will use self-reported questionnaire using visual analogue scale (VAS) ranging from 0 to 10.
Measured: All time (baseline, 3month and 6 months after intervention)
Quality of life at the time
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 and breast specific module
Measured: All time (baseline, 3month and 6 months after intervention)
Satisfaction with products
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.
Measured: All time (baseline, 3month and 6 months after intervention)
Willing to Pay
We will ask how much to willing to pay for CG428
Measured: 6 months after intervention
Hair condition
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
Measured: All time (baseline, 3month and 6 months after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start15 Jan 2016
- Primary completion15 Dec 2016
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Legacy Healthcare Services
- Responsible party
- Principal investigator, Juhee Cho, Samsung Medical Center
- Investigators
- Juhee Cho, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986412
- Sponsor's protocol ID
- VOLUME2
- Acronym
- VOLUME2
- Status last verified
- Aug 2018
- First submitted
- 6 Dec 2016
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02986412
- Acronym / sponsor ID
- VOLUME2 / VOLUME2
- Conditions
- Alopecia, Chemotherapy Effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Legacy Healthcare Services
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
The "VOLUME" study could have in fact two major repercussions: in addition to give information on CG428 efficacy, it will help to better define persistent CIA and improve thereby our scientific knowledge of this condition. Considering the high prevalence and poor literature on persistent CIA, it appears important to study this condition further.
To this end, we would suggest to conduct "VOLUME-2" study, as an extension of the ongoing "VOLUME" study with all subjects already included.
This study aims to evaluation of Longer observation (12 months : 6months Volume + 6 months Volume-2) permitting to better discriminate later or non-responder populations.
This is a open-label, single center, observation study in breast cancer survivors of VOLUME participants.
Hair condition and parameters of 31 breast cancer survivors who were previously included in VOLUME study (a randomized controlled trial to evaluate effect of CG428 which is topical hair lotion for chemotherapy induced alopecia completed in December, 2016) will be assessed.
The participation du extension Volume-2 study will be proposed to patients during the last visit of Volume study (Month 6)
The "VOLUME" study could have in fact two major repercussions: in addition to give information on CG428 efficacy, it will help to better define persistent CIA and improve thereby our scientific knowledge of this condition. Considering the high prevalence and poor literature on persistent CIA, it appears important to study this condition further.
To this end, we would suggest to conduct "VOLUME-2" study, as an extension of the ongoing "VOLUME" study with all subjects already included.
This study aims to evaluation of Longer observation (12 months : 6months Volume + 6 months Volume-2) permitting to better discriminate later or non-responder populations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CG428 | Experimental | Other: CG428Patients will self-administer the study product twice per day (morning, evening) for 6 months, for the efficacy assessment |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CG428The 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. | Other | CG428 |
Primary outcome
Hair thickness
Time frame: 6 months after intervention
Objectively quantified hair thickness will measure using Folliscope 4.0, LeadM
8 secondary outcomes
Chemotherapy-induced alopecia distress Stress Using Chemotherapy induced
Time frame: All time (baseline, 3month and 6 months after intervention)
Global photographs
Time frame: All time (baseline, 3month and 6 months after intervention)
Overall hair and scalp condition
Time frame: All time (baseline, 3month and 6 months after intervention)
Nail condition
Time frame: All time (baseline, 3month and 6 months after intervention)
Quality of life at the time
Time frame: All time (baseline, 3month and 6 months after intervention)
Satisfaction with products
Time frame: All time (baseline, 3month and 6 months after intervention)
Willing to Pay
Time frame: 6 months after intervention
Hair condition
Time frame: All time (baseline, 3month and 6 months after intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- EValuation of the Impact of a TOpical Lotion on Permanent Chemotherapy Induced Hair Disorders in Cancer Survivors (VOLUME)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juhee Cho, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CG428 in people with Alopecia and Chemotherapy Effects, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair thickness (time frame: 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018.