The Topical Application of Vitamin B6 in Palmar-Plantar Erythrodysesthesia

Not Applicable

Completed

• Conditions: Palmar-Plantar Erythrodysesthesia
• Interventions: Device: Vitamin B6 cream; Device: Placebo Vitamin B6 cream

• Registration Number: NCT02625415
• Lead Sponsor: Cyprus University of Technology

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 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 Timeline

• Study First Submitted: 2015-12-05
• Study First Submitted QC: 2015-12-08
• Study First Posted: 2015-12-09
• Study Start: 2016-07
• Primary Completion: 2018-05-01
• Study Completion: 2018-06-15
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-06
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin B6	Vitamin B6 cream	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.
Placebo	Placebo Vitamin B6 cream	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.

Primary Outcome Measures

Name	Time	Method
PPE grade	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)

Secondary Outcome Measures

Name	Time	Method
Health Related Quality of Life	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	up to 4 weeks	This is a quality of life scale specifically for patients experiencing radiation-induced PPE

Trial Locations

Locations (2)

Limassol General Hospital; 🇨🇾 Limassol, Cyprus

American Medical Center; 🇨🇾 Nicosia, Cyprus