The Topical Application of Vitamin B6 in Palmar-Plantar Erythrodysesthesia

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

Detailed Description
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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.

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

Conditions
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Palmar-Plantar Erythrodysesthesia

Intervention / Treatment
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* Device: Vitamin B6 cream
* Device: Placebo Vitamin B6 cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin B6<br>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<br>* Topical Vitamin B6 cream<br>|
| Placebo Comparator: Placebo<br>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<br>* Placebo Vitamin B6 cream<br>|

What is the study measuring?
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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 |