Alleviation of Alopecia in Breast Cancer Patient Using Synbiotics Formula

August 15, 2024 updated by: GenieBiome Limited

A Pilot, Double-blind, Randomised, Placebo-controlled Trial on the Efficacy of a Synbiotic Formula (BLHK03) in Alleviating Chemotherapy-induced Alopecia (CIA) in Breast Cancer Patients

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In a mice study, it was shown that oral administration of a probiotic isolated from healthy faeces, B. longum HK003, has protective effects against alopecia related to chemotherapy. Mice were treated with 100 mg/kg cyclophosphamide (CYP) once monthly, for 4 months. The CYP-treated mice were then treated with B. longum HK003 for 14 days. Results showed that B. longum treatment significantly enhanced skin thickness histologically. In the subcutis, the quantity and size of anagen follicles were increased, whilst the quantity of atrophic follicles were decreased.

Currently, there is no documentation of potential probiotic-drug interactions in breast cancer patients undergoing chemotherapy. A previous randomized controlled trial reported no adverse event associated with the use of synbiotics in breast cancer patients during the treatment period(9). Beneficial effects on chemotherapy-induced fatigue and abnormal stool consistency were also observed in subjects receiving synbiotics(9).

Biotin is a water-soluble vitamin that is naturally present in some food and available as a dietary supplement for healthy hair and nails due to its role in keratin production. Most healthy individuals achieve adequate intake of biotin through a well-balanced diet. Current recommendation for biotin by the Food and Nutrition Board (FNB) at the National Academies of Sciences, Engineering, and Medicine stated that the daily adequate intake (AI) for adults is 30 mcg/day. Although biotin has been widely used as dietary supplement, data on the actual benefit of its effect on hair growth is limited(10).

The use of B. longum HK003 in alleviating chemotherapy-induced alopecia in breast cancer patients has not been explored. This pilot, double-blind, randomised, placebo-controlled trial aims to explore on the efficacy and safety of a synbiotic formula (BLHK03) in alleviating chemotherapy-induced alopecia (CIA) in breast cancer patients.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • GenieBiome Limited
        • Contact:
        • Principal Investigator:
          • Henry Chun Kin Sze, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Known pregnancy or lactating
  • Severe cardiac, hepatic, renal, pulmonary and haematic lesions or other life-threatening conditions
  • Use of antibiotics, probiotics or prebiotics one month prior to enrolment
  • No other alternative or complementary treatment for the cancer condition that may affect the gut microbiome analysis
  • History of allergy to probiotics or lactose
  • History of chemotherapy for other conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active arm
Subjects will receive 1 sachet of BLHK03 daily from the start of the chemotherapy cycle to 2 months after the final dose of chemotherapy.
Dietary supplement: BLHK03
BLHK03 consists of a blend of probiotics (20 billion CFU in 1 sachet) and prebiotic compounds
Placebo Comparator: Placebo arm
Subjects will receive 1 sachet of active placebo daily from the start of the chemotherapy cycle to 2 months after the final dose of chemotherapy.
Dietary supplement: Active placebo
Active placebo contains 5mcg of Vitamin B7

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline to 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.
Baseline to 2 months after the final dose of chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut microbial change at 2 months after the final dose of chemotherapy
Time Frame: Baseline to 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
Baseline to 2 months after the final dose of chemotherapy
Adverse event rates related to the study during the study period
Time Frame: Baseline to 2 months after the final dose of chemotherapy
The adverse events reported throughout the study
Baseline to 2 months after the final dose of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GenieBiome Limited

Investigators

  • Study Director: Jessica Ching, PhD, GenieBiome Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 19, 2024

Primary Completion (Estimated)

August 18, 2025

Study Completion (Estimated)

August 18, 2026

Study Registration Dates

First Submitted

August 15, 2024

First Submitted That Met QC Criteria

August 15, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 15, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCIA Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe