The Topical Application of Vitamin B6 in Palmar-Plantar Erythrodysesthesia

Palmar-Plantar Erythrodysesthesia Clinical Trial

— HFSB6  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625415
• Other study ID #: AC-PPEHP-89
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: June 15, 2018

Study information

• Verified date: August 2018
• Source: Cyprus University of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 15, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hand-Foot Syndrome
• Palmar-Plantar Erythrodysesthesia

Intervention

Device:
• Vitamin B6 cream
Topical Vitamin B6 cream
• Placebo Vitamin B6 cream
Placebo Vitamin B6 cream

Locations

Country	Name	City	State
Cyprus	Limassol General Hospital	Limassol
Cyprus	American Medical Center	Nicosia

Sponsors (2)

Lead Sponsor	Collaborator
Cyprus University of Technology	American Medical Center

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Treatment side-effects	Any possible side-effect due to the treatment will be recorded	up to 4 weeks
Primary	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	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
Secondary	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