A pilot clinical trial assessing the efficacy and safety of supplementation with a B complex vitamin to reduce the incidence of chemotherapy induced peripheral neuropathy in patients diagnosed with a malignancy.

niversity of Queensland - Centre for Integrative Clinical and Molecular Medicine0 sites135 target enrollmentJanuary 21, 2011

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chemotherapy induced peripheral neuropathy
Sponsor: niversity of Queensland - Centre for Integrative Clinical and Molecular Medicine
Enrollment: 135
Status: Completed
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

January 21, 2011

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Queensland - Centre for Integrative Clinical and Molecular Medicine

•1\. Newly diagnosed with a neoplastic disease;
•2\. Have been prescribed chemotherapy treatment with paclitaxel, vincristine or oxaliplatin.

•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.