Health TrialsbyHealthPanel

Alleviation of Alopecia in Breast Cancer Patient Using Synbiotics Formula

ConditionsBreast CancerHair Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorGenieBiome Limited

About this trial

This study aims to explore the efficacy and safety of a synbiotic formula (BLHK03) in alleviating chemotherapy-induced alopecia (CIA) in breast cancer patients and the compositional and functional changes in the gut microbiome of breast cancer patients undergoing chemotherapy and treatment with BLHK03.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Females aged between 18 and 60 years who are newly diagnosed with stage I, II or III breast cancer

Planned chemotherapy including an anthracycline or taxane to be completed within 6 months

Mentally capable to participate in the study and provide informed consent

Disqualifiers

Pre-existing female-pattern baldness resembling picture I-3 or higher on the Savin scale at baseline

History of hair transplantation, psoriasis or severe scalp infection

Undergoing or plan to receive scalp cooling

Plan for immunotherapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • BLHK03

    Dietary supplement

    BLHK03 consists of a blend of probiotics (20 billion CFU in 1 sachet) and prebiotic compounds

  • Active placebo

    Dietary supplement

    Active placebo contains 5mcg of Vitamin B7

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Active armActive comparator 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The proportion of subjects with a score of ≤ 2 on the Dean scale (corresponding to hair loss ≤ 50%) 2 months after the final dose of chemotherapy

The change of Dean scale (corresponding to hair loss) after chemotherapy compared to baseline. Score 0 means no hair loss and score 4 means all hair is fallen down.

Time frame
Baseline to 2 months after the final dose of chemotherapy

Secondary outcomes

1

Gut microbial change at 2 months after the final dose of chemotherapy

The change of gut microbiota composition at 2 months after the final dose of chemotherapy compared to baseline

Time frame
Baseline to 2 months after the final dose of chemotherapy
2

Adverse event rates related to the study during the study period

The adverse events reported throughout the study

Time frame
Baseline to 2 months after the final dose of chemotherapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GenieBiome Limited

Lead sponsor

Source ClinicalTrials.gov
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