Oral B-Complex Vitamin (B6, B9 and B12) Prevents Low Anterior Resection Syndrome in Rectal Cancer Patients With Hyperhomocysteinemia
Key facts
- Where
- Jinan, KínaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Forrás: NCT07928180: ki vehet részt
Where in Kína
- Qilu Hospital of Shandong UniversityJinan, KínaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Qilu Hospital of Shandong University
- Trial code
- NCT07928180
- Record updated
- 2026. november 10.
- Original description
The goal of this clinical trial is to investigate if taking Oral B-Complex Vitamin (B6, B9 and B12) can help prevent low anterior resection syndrome (LARS) in rectal cancer patients with hyperhomocysteinemia after sphincter-preserving surgery for rectal cancer. LARS is a group of bowel problems that can occur after rectal cancer surgery, including frequent bowel movements, an urgent need to have a bowel movement, constipation, and loss of bowel control.Read full original descriptionShow less
Oral B-Complex Vitamin (B6, B9 and B12) Supplementation for the Prevention of Low Anterior Resection Syndrome After Sphincter-Preserving Surgery in Rectal Cancer Patients With Hyperhomocysteinemia: A Randomized Controlled Trial
The goal of this clinical trial is to investigate if taking Oral B-Complex Vitamin (B6, B9 and B12) can help prevent low anterior resection syndrome (LARS) in rectal cancer patients with hyperhomocysteinemia after sphincter-preserving surgery for rectal cancer. LARS is a group of bowel problems that can occur after rectal cancer surgery, including frequent bowel movements, an urgent need to have a bowel movement, constipation, and loss of bowel control.
Our previous research suggests that hyperhomocysteinemia increased the occurrence of LARS. Folic acid, vitamin B6 and vitamin B12 are a safe, widely used way to treat hyperhomocysteinemia.
The main questions this study aims to answer are:
* Does taking Oral B-Complex Vitamin (B6, B9 and B12) lower the rate of LARS 6 months after surgery? * How does this treatment affect internal anal sphincter (IAS) function?
Researchers will compare Oral B-Complex Vitamin (B6, B9 and B12) with a placebo (a look-alike tablet that contains no vitamins) to see if Oral B-Complex Vitamin (B6, B9 and B12) can help prevent LARS.
Participants will:
* Take B-Complex Vitamin (B6, B9 and B12) every day for 6 months * Visit the clinic twice ( 3 months and 6 months after surgery) for checkups and tests * Complete the LARS score questionnaire 6 months after surgery
Inclusion: Aged 18 to 75 years; Body mass index (BMI) of 18.5 to 28 kg/m2; Low anterior resection performed for rectal cancer; Serum homocysteine level between 15 and 50 μmol/L both before and after surgery; No evidence of tumor recurrence or distant metastasis; No short-term postoperative complications at the time of enrollment; Able to resume oral intake after surgery; Signed written informed consent.
Exclusion: History of, or planned, neoadjuvant or adjuvant radiotherapy or chemotherapy; Other severe chronic diseases, such as cardiovascular or cerebrovascular disease, diabetes mellitus or chronic respiratory disease; Renal insufficiency, epilepsy, or other gastrointestinal diseases; Hyperhomocysteinemia caused by inherited defects, such as cystathionine beta-synthase deficiency, methylenetetrahydrofolate reductase (MTHFR) deficiency or hereditary folate malabsorption, screened by detailed medical and family history; highly suspected cases will be referred for specialist diagnosis and excluded; Participation in any other clinical study within the past 3 months.