Clinical Trial: The Topical Application of Vitamin B6 in Palmar-Plantar Erythrodysesthesia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Double Blind Placebo Control Randomised Trial to Test the Effectiveness of Vitamin B6 in Hand Foot Syndrome

Brief Summary: The study is designed to test the effectiveness of topical B6 cream in patients that developed Palmar-Plantar Erythrodysesthesia (Hand foot syndrome).

Detailed Summary:

This will be a randomized double-blind, placebo-controlled study with 100 cancer patients that will receive chemotherapy treatment with capecitabine and/or pegylated liposomal doxorubicin. The selection of potential participants will be based on inclusion and exclusion criteria. Patients will be randomly allocated either to the treatment group or the placebo group. Treatment will be delivered daily (t.d.s) and assessments will take place at 0, 1, 2, 3 and 4 weeks.

The intervention group will receive the application of topical vitamin B6 cream to the hands and/or feet of the patients and the control group will receive the placebo.

At both baseline and follow-up, patients in both groups will be assessed for their degree of palmar-plantar erythrodysesthesia, the Quality of Life, the need for dose-limiting due to PPE and Pain intensity using standardized rating scales. Data will be analysed with inferential and descriptive statistics.


Sponsor: Cyprus University of Technology

Current Primary Outcome: PPE grade [ Time Frame: up to 4 weeks ]

The grade of PPE will be assessed with a standardised three-grade system previously used in capecitabine clinical trials (Scheithauer et al 2003)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Health Related Quality of Life [ Time Frame: up to 4 weeks ]
    The HRQoL of the patients will be assessed with the EORTC QLQ -C30 module which has been developed and validated explicitly for patients suffering from cancer.
  • Quality of Life in relation to PPE [ Time Frame: up to 4 weeks ]
    This is a quality of life scale specifically for patients experiencing radiation-induced PPE


Original Secondary Outcome: Same as current

Information By: Cyprus University of Technology

Dates:
Date Received: December 5, 2015
Date Started: July 2016
Date Completion: March 2018
Last Updated: February 9, 2017
Last Verified: February 2017