Skip to content

A randomized controlled trial for probiotics (Baiyichun) + vitamin B6 versus vitamin B6 in the treatment of moderate to severe skin and foot skin reactions induced by multi-targeted kinase inhibitors in cancer patients

A randomized controlled trial for probiotics (Baiyichun) + vitamin B6 versus vitamin B6 in the treatment of moderate to severe skin and foot skin reactions induced by multi-targeted kinase inhibitors in cancer patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022761
Enrollment
Unknown
Registered
2019-04-25
Start date
2019-04-23
Completion date
Unknown
Last updated
2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hand-foot skin reaction

Interventions

A:Baiyichun + Vitamin B6
B:Vitamin B6

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Aged 18 or above, male or female; 2) Cancer patients who take anticancer drugs and have grade =2 HFS/HFSR, and the expected treatment time of anticancer drugs is =6 weeks (42 days); 3) Expected survival time > 6 months; 4) If various methods are being used to treat HFS/HFSR prior to enrollment, the treatment used is not valid. The drug for the treatment of HFS/HFSR was discontinued for =1 week before randomization; 5) If the patient has used drugs to prevent HFS/HFSR before enrollment, but the prevention effect is not good, 2 degrees of HFS/HFSR can be enrolled, but the preventive drug needs to be stopped for =1 week. Or if the patient requests to continue using the original preventive drug, the preventive drug is required to be a topical drug and the original prevention program needs to be adhered to throughout the trial period; 6) ECOG score = 2; 7) Signing informed consent; 8) Good compliance.

Exclusion criteria

Exclusion criteria: 1) Pregnant or lactating women; 2) Those who took antibiotics or drugs and foods containing probiotics within 3 weeks of enrollment; 3) Patients with multiple organ tumors or severe uncontrolled medical or acute infections; 4) The patient has previously used oral medications other than vitamin B6 to prevent HFS/HFSR and did not agree to terminate the original oral medication during the trial; 5) The patient cannot understand the research purpose or disagree with the research requirements; 6) Not legally competent or legally restricted; 7) The researcher judges that the compliance is not good and cannot strictly implement the plan; 8) Any medical history may interfere with the test results or increase the patient's risk, judged by the investigator; 9) drink other foods or beverages containing probiotics during the study period; 10) With serious heart, lung, liver, kidney and other important organ diseases.

Design outcomes

Primary

MeasureTime frame
The ratio of HFS/HFSR restored to 0-1 degree;

Countries

China

Contacts

Public ContactQian Chu
qianchu@tjh.tjmu.edu.cn+86 027 83663407

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026