Alleviation of Alopecia in Breast Cancer Patient Using Synbiotics Formula
Recruiting · NCT06560385 · Interventional (participants receive a specific treatment) · Lead sponsor: GenieBiome Limited
View the official record on ClinicalTrials.gov →Interventions studied
Active placeboBLHK03
What this trial is about
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.
Who can take part
Age range
18 Years to 60 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed.
- GenieBiome Limited - Hong Kong, Hong Kong
- Heal Medical - Hong Kong, Hong Kong