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.

Phase 1

Completed

• Conditions: Chemotherapy induced peripheral neuropathy; Cancer - Other cancer types

• Registration Number: ACTRN12611000078954
• Lead Sponsor: niversity of Queensland - Centre for Integrative Clinical and Molecular Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 135

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Neuropathy Score (TNS)[Tested T0, T12 or T24, T36 weeks from start of chemotherapy<br><br>Patients will be tested before chemotherapy (T0 weeks), at the end of their chemotherapy regime (T12 or T24 weeks) and at the end of the trial (T36 weeks)]

Secondary Outcome Measures

Name	Time	Method
EORTC Quality of Life Questionnaire[T0, T12, T24, T36 weeks];Brief Pain Inventory[T0, T12, T24, T36 weeks];Patient Neurotoxicity Questionnaire (PNQ)[T0, T12, T24, T36 weeks plus every second week for brief PNQ];Blood pathology for B vitamins (B1, B2, B6, B12, folate)[T0, T12 or T24<br><br>Patients will be tested before chemotherapy commences (T0), and at the end of their chemotherapy regime (T12 or T24 weeks).]