Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560385
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Alleviation of Alopecia in Breast Cancer Patient Using Synbiotics Formula
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 mgkg 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 period9 Beneficial effects on chemotherapy-induced fatigue and abnormal stool consistency were also observed in subjects receiving synbiotics9
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 mcgday Although biotin has been widely used as dietary supplement data on the actual benefit of its effect on hair growth is limited10
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
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 period9 Beneficial effects on chemotherapy-induced fatigue and abnormal stool consistency were also observed in subjects receiving synbiotics9
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 mcgday Although biotin has been widely used as dietary supplement data on the actual benefit of its effect on hair growth is limited10
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None