The Topical Application of Vitamin B6 in Palmar-Plantar Erythrodysesthesia (HFSB6)
Primary Purpose
Palmar-Plantar Erythrodysesthesia
Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Vitamin B6 cream
Placebo Vitamin B6 cream
Sponsored by
About this trial
This is an interventional supportive care trial for Palmar-Plantar Erythrodysesthesia
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
Sites / Locations
- Limassol General Hospital
- American Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin B6
Placebo
Arm 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.
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Quality of Life in relation to PPE
This is a quality of life scale specifically for patients experiencing radiation-induced PPE
Full Information
NCT ID
NCT02625415
First Posted
December 5, 2015
Last Updated
August 6, 2018
Sponsor
Cyprus University of Technology
Collaborators
American Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02625415
Brief Title
The Topical Application of Vitamin B6 in Palmar-Plantar Erythrodysesthesia
Acronym
HFSB6
Official Title
A Double Blind Placebo Control Randomised Trial to Test the Effectiveness of Vitamin B6 in Hand Foot Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cyprus University of Technology
Collaborators
American Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palmar-Plantar Erythrodysesthesia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin B6
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Vitamin B6 cream
Intervention Description
Topical Vitamin B6 cream
Intervention Type
Device
Intervention Name(s)
Placebo Vitamin B6 cream
Intervention Description
Placebo Vitamin B6 cream
Primary Outcome Measure Information:
Title
PPE grade
Description
The grade of PPE will be assessed with a standardised three-grade system previously used in capecitabine clinical trials (Scheithauer et al 2003)
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
Health Related Quality of Life
Description
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.
Time Frame
up to 4 weeks
Title
Quality of Life in relation to PPE
Description
This is a quality of life scale specifically for patients experiencing radiation-induced PPE
Time Frame
up to 4 weeks
Other Pre-specified Outcome Measures:
Title
Activities of daily living
Description
Activities of daily living will be assessed with the Eastern Co-operative Oncology Group (ECOG)/WHO system
Time Frame
up to 4 weeks
Title
Treatment side-effects
Description
Any possible side-effect due to the treatment will be recorded
Time Frame
up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Limassol General Hospital
City
Limassol
Country
Cyprus
Facility Name
American Medical Center
City
Nicosia
ZIP/Postal Code
1311
Country
Cyprus
12. IPD Sharing Statement
Citations:
PubMed Identifier
33227569
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.
Results Reference
derived
Learn more about this trial
The Topical Application of Vitamin B6 in Palmar-Plantar Erythrodysesthesia
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