Status:
RECRUITING
Alleviation of Alopecia in Breast Cancer Patient Using Synbiotics Formula
Lead Sponsor:
GenieBiome Limited
Conditions:
Breast Cancer
Hair Loss
Eligibility:
FEMALE
18-60 years
Phase:
NA
Brief 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 cha...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 18 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06560385
Start Date
September 11 2024
End Date
August 18 2026
Last Update
September 19 2024
Active Locations (2)
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1
GenieBiome Limited
Hong Kong, Hong Kong
2
Heal Medical
Hong Kong, Hong Kong