RecruitingNot ApplicableNCT06560385

Alleviation of Alopecia in Breast Cancer Patient Using Synbiotics Formula

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


Sponsor

GenieBiome Limited

Enrollment

40 participants

Start Date

Sep 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 60 Years

Inclusion Criteria3

  • 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 Criteria10

  • 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

Interventions

DIETARY_SUPPLEMENTBLHK03

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

DIETARY_SUPPLEMENTActive placebo

Active placebo contains 5mcg of Vitamin B7


Locations(2)

GenieBiome Limited

Hong Kong, Hong Kong

Heal Medical

Hong Kong, Hong Kong

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NCT06560385


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