A 6-month Post-interventional Follow-up Extension of VOLUME Study (VOLUME-2)
Condition: Alopecia; Chemotherapy Effects
MeSH terms: Alopecia
Study type: Interventional

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". 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.
    

Intervention name(s): CG428
Intervention type(s): Other
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care