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

Cyprus University of Technology

Status: Completed

Conditions: Palmar-Plantar Erythrodysesthesia

Treatments: Device: Placebo Vitamin B6 cream; Device: Vitamin B6 cream

Study type: Interventional

Funder types: Other

Identifiers

NCT02625415

AC-PPEHP-89

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 2 patient groups, including a placebo group

Vitamin B6

Experimental group

Description:

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.

Treatment:

Device: Vitamin B6 cream

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo Vitamin B6 cream