Breast CancerNCT06560385
Alleviation of Alopecia in Breast Cancer Patient Using Synbiotics Formula
A study testing BLHK03 in people with Breast Cancer and Hair Loss, run by GenieBiome Limited at 2 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer, Hair Loss
- What is being tested?
- BLHK03
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 2 sitesHong Kong
- Study dates
- 11 Sep 2024to 18 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Hair Loss
- Being tested
- BLHK03, Active placebo
- Keywords
- Breast Cancer, Hair Loss, Chemotherapy, Synbiotic
- Medical subject headings
- Breast Neoplasms, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLHK03Dietary supplement
BLHK03 consists of a blend of probiotics (20 billion CFU in 1 sachet) and prebiotic compounds
Active placeboDietary supplement
Active placebo contains 5mcg of Vitamin B7
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Active comparator | Subjects will receive 1 sachet of BLHK03 daily from the start of the chemotherapy cycle to 2 months after the final dose of chemotherapy. Receives: Dietary Supplement: BLHK03 |
| Placebo arm | Placebo comparator | 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. Receives: Dietary Supplement: Active placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 2 months after the final dose of chemotherapy
Secondary outcomes (2)
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
Measured: Baseline to 2 months after the final dose of chemotherapy
Adverse event rates related to the study during the study period
The adverse events reported throughout the study
Measured: Baseline to 2 months after the final dose of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start11 Sep 2024
- Primary completion18 Aug 2025
- Study completion18 Aug 2025
Why it stopped: No enough subjects within the recruitment period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All subjects will be randomized into two group to take BLHK03 or active placebo (Vitamin B7) daily from the start of the chemotherapy cycle to 2 months after the final dose of chemotherapy.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- GenieBiome Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jessica Ching, PhD, Study director, GenieBiome Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560385
- Sponsor's protocol ID
- BCIA Study
- Status last verified
- Oct 2025
- First submitted
- 15 Aug 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lam S, Zhang J, Yang K, Chu LC, Zhu W, Tang W, Chan FKL, Chan PKS, Wu WKK, Ng SC. Modulation of gut microbiota impacts diet-induced and drug-induced alopecia in mice. Gut. 2022 Nov;71(11):2366-2369. doi: 10.1136/gutjnl-2021-326320. Epub 2022 Jan 5. No abstract available.
PubMed 34987064Khazaei Y, Basi A, Fernandez ML, Foudazi H, Bagherzadeh R, Shidfar F. The effects of synbiotics supplementation on reducing chemotherapy-induced side effects in women with breast cancer: a randomized placebo-controlled double-blind clinical trial. BMC Complement Med Ther. 2023 Sep 26;23(1):339. doi: 10.1186/s12906-023-04165-8.
PubMed 37752516Patel DP, Swink SM, Castelo-Soccio L. A Review of the Use of Biotin for Hair Loss. Skin Appendage Disord. 2017 Aug;3(3):166-169. doi: 10.1159/000462981. Epub 2017 Apr 27.
PubMed 28879195
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06560385
- Acronym / sponsor ID
- BCIA Study
- Conditions
- Breast Cancer, Hair Loss
- Keywords
- Breast Cancer, Hair Loss, Chemotherapy, Synbiotic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No enough subjects within the recruitment period
- Enrolment
- 7 participants (actual)
- Lead sponsor
- GenieBiome LimitedIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- All subjects will be randomized into two group to take BLHK03 or active placebo (Vitamin B7) daily from the start of the chemotherapy cycle to 2 months after the final dose of chemotherapy.
| Arm | Type | Receives |
|---|---|---|
| Active arm | Active comparator | Dietary Supplement: BLHK03Subjects will receive 1 sachet of BLHK03 daily from the start of the chemotherapy cycle to 2 months after the final dose of chemotherapy. |
| Placebo arm | Placebo comparator | Dietary Supplement: Active placeboSubjects will receive 1 sachet of active placebo daily from the start of the chemotherapy cycle to 2 months after the final dose of chemotherapy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLHK03BLHK03 consists of a blend of probiotics (20 billion CFU in 1 sachet) and prebiotic compounds | Dietary supplement | Active arm |
| Active placeboActive placebo contains 5mcg of Vitamin B7 | Dietary supplement | Placebo arm |
Primary outcome
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.
2 secondary outcomes
Gut microbial change at 2 months after the final dose of chemotherapy
Time frame: 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
Results and safety
The study was stopped early (reason given: No enough subjects within the recruitment period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Background: PubMed 34987064Lam S, Zhang J, Yang K, Chu LC, Zhu W, Tang W, Chan FKL, Chan PKS, Wu WKK, Ng SC. Modulation of gut microbiota impacts diet-induced and drug-induced alopecia in mice. Gut. 2022 Nov;71(11):2366-2369. doi: 10.1136/gutjnl-2021-326320. Epub 2022 Jan 5. No abstract available.
- Background: PubMed 37752516Khazaei Y, Basi A, Fernandez ML, Foudazi H, Bagherzadeh R, Shidfar F. The effects of synbiotics supplementation on reducing chemotherapy-induced side effects in women with breast cancer: a randomized placebo-controlled double-blind clinical trial. BMC Complement Med Ther. 2023 Sep 26;23(1):339. doi: 10.1186/s12906-023-04165-8.
- Background: PubMed 28879195Patel DP, Swink SM, Castelo-Soccio L. A Review of the Use of Biotin for Hair Loss. Skin Appendage Disord. 2017 Aug;3(3):166-169. doi: 10.1159/000462981. Epub 2017 Apr 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Ching, PhD study director
GenieBiome Limited
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BLHK03 in people with Breast Cancer and Hair Loss, run by GenieBiome Limited at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No enough subjects within the recruitment period). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06560385, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.