The Topical Application of Vitamin B6 in Palmar-Plantar Erythrodysesthesia

NCT02625415 | Completed DMC

• 1 other identifier: AC-PPEHP-89
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Palmar-Plantar Erythrodysesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Health Related Quality of Life

  up to 4 weeks

• Quality of Life in relation to PPE

  up to 4 weeks

Other Outcomes (2)

• Activities of daily living

  up to 4 weeks

• Treatment side-effects

  up to 4 weeks

Study Arms (2)

Vitamin B6

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Vitamin B6 cream DEVICE

Topical Vitamin B6 cream

Vitamin B6

Placebo Vitamin B6 cream DEVICE

Placebo Vitamin B6 cream

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cyprus University of Technology: lead
• American Medical Center: collaborator

Study Sites (2)

Limassol General Hospital

Limassol, Cyprus

Location

American Medical Center

Nicosia, 1311, Cyprus

Location

Related Publications (1)

• 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.

  PMID: 33227569 DERIVED

MeSH Terms

Conditions

Hand-Foot Syndrome

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 5, 2015
• First Posted: December 9, 2015
• Study Start: July 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: June 15, 2018
• Last Updated: August 7, 2018

Record last verified: 2018-08

Locations

CY (2)