The Topical Application of Vitamin B6 in Palmar-Plantar Erythrodysesthesia (HFSB6)

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

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

Study Overview

• Status: Completed
• Conditions: Palmar-Plantar Erythrodysesthesia
• Intervention / Treatment: Device: Vitamin B6 cream; Device: Placebo Vitamin B6 cream

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cyprus
  • Limassol, Cyprus
    • Limassol General Hospital
  • Nicosia, Cyprus, 1311
    • American Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult cancer patients (>18)
• Patients receiving capecitabine and/or PLD as monotherapy or in combination with other agents
• Patients that will experience PPE grade 1 or above
• Willing to participate
• Ability to complete the psychometric assessments.
• A performance status of two or less on the Eastern Cooperative Oncology Group (ECOG

Exclusion Criteria:

• Patients with hypersensitivity to Vitamin B.
• Patients with pre-existing dermatological condition affecting the hands or/and feet that may limit the interpretation of results
• Patients on oral Pyridoxine or nicotine patches
• Patients with a previous history of PPE
• Patients whose chemotherapy was discontinued for more than a week

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin B6; Topical application of B6 cream to the hand or/and feet 1-2 ml applied to the hand or /and feet three times a day for 4 weeks.	Device: Vitamin B6 cream; Topical Vitamin B6 cream
Placebo Comparator: Placebo; Topical application of B6 Placebo cream to the hand or/and feet 1-2 ml applied to the hand or /and feet three times a day for 4 weeks.	Device: Placebo Vitamin B6 cream; Placebo Vitamin B6 cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PPE grade	The grade of PPE will be assessed with a standardised three-grade system previously used in capecitabine clinical trials (Scheithauer et al 2003)	up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Related Quality of Life	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.	up to 4 weeks
Quality of Life in relation to PPE	This is a quality of life scale specifically for patients experiencing radiation-induced PPE	up to 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activities of daily living	Activities of daily living will be assessed with the Eastern Co-operative Oncology Group (ECOG)/WHO system	up to 4 weeks
Treatment side-effects	Any possible side-effect due to the treatment will be recorded	up to 4 weeks

Collaborators and Investigators

• Sponsor: Cyprus University of Technology
• Collaborators: American Medical Center

Publications and helpful links

General Publications

• Charalambous A, Tsitsi T, Astras G, Paikousis L, Filippou E. A pilot randomized double-blind, placebo-controlled study on the effects of the topical application of pyridoxine on palmar-plantar erythrodysesthesia (PPE) induced by capecitabine or pegylated liposomal doxorubicin (PLD). Eur J Oncol Nurs. 2021 Feb;50:101866. doi: 10.1016/j.ejon.2020.101866. Epub 2020 Nov 11.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): June 15, 2018

Study Registration Dates

• First Submitted: December 5, 2015
• First Submitted That Met QC Criteria: December 8, 2015
• First Posted (Estimate): December 9, 2015

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: August 6, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Skin Diseases; Dermatitis; Drug-Related Side Effects and Adverse Reactions; Drug Eruptions; Drug Hypersensitivity; Hand-Foot Syndrome; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Vitamin B 6; Pyridoxal; Pyridoxine
• Other Study ID Numbers: AC-PPEHP-89