None listed
Conditions
Brief summary
This study aims to determine whether vitamin B supplementation can reduce the incidence of chemotherapy induced peripheral neuropathy (nerve damage) in patients diagnosed with cancer. Who is it for? You can join this study if you have been recently diagnosed with cancer for which you have been prescribed chemotherapy treatment with the drug paclitaxel, vincristine or oxaliplatin. Trial details Participants will be randomly allocated to one of two groups. One group will take 2 capsules of vitamin B complex daily 1 week before chemotherapy treatment for 9 months. The other group will be given 2 capsules of a placebo (sugar capsule) to take daily for 9 months. Patients will be assessed at three timepoints over the study duration to evaluate neuropathy, quality of life, pain, and levels of vitamin B in the blood.
Interventions
Oral B group vitamin complex
a) the dose administered is 1 capsule twice a day equivalent to 100mg of B1, 1000mcg of B12, 1000mcg of folinic acid, 60mg of B6, 1000mcg of biotin, 327mg of B5, 200mcg of inositol, 200mg of B3, and 40mg of B2.
b) the duration administered is 36 weeks; and
c) administration begins 7 days prior to commencement of chemotherapy administration
Sponsors
University of Queensland - Centre for Integrative Clinical and Molecular Medicine
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Newly diagnosed with a neoplastic disease; 2. Have been prescribed chemotherapy treatment with paclitaxel, vincristine or oxaliplatin.
Exclusion criteria
1. Participants who will be prescribed any other concurrent investigational products 2. Currently experiences peripheral neuropathy 3. Have undergone chemotherapy treatment before with a neurotoxic agent 4. Have undergone chemotherapy treatment within the last five years 6. Women who are currently pregnancy or breast feeding 7. Any patient with established cognitive impairment, alcoholism, intellectual disability or severe mental illness 8. Any patient found to be deficient in vitamin B12 or folate after initial baseline blood pathology testing. 9. Any patients taking concurrent multivitamins, nutritional and herbal supplements or fish oils.
Outcome results
None listed