Clinical trial NCT02625415: The Topical Application of Vitamin B6 in Palmar-Plantar Erythrodysesthesia
Official title: A Double Blind Placebo Control Randomised Trial to Test the Effectiveness of Vitamin B6 in Hand Foot Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palmar-Plantar Erythrodysesthesia
Lead sponsor: Cyprus University of Technology
Sponsor class: OTHER
Collaborators: name: American Medical Center
First posted: 2015-12-09
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: PPE grade
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Health Related Quality of Life
timeFrame: up to 4 weeks
measure: Quality of Life in relation to PPE
timeFrame: up to 4 weeks
Other outcomes:
measure: Activities of daily living
timeFrame: up to 4 weeks
measure: Treatment side-effects
timeFrame: up to 4 weeks
Locations:
city: Limassol
country: Cyprus
facility: Limassol General Hospital
city: Nicosia
country: Cyprus
facility: American Medical Center
Study officials:
References:
citation: 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.