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

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ClinicalTrials.gov Identifier: NCT02625415
Recruitment Status : Recruiting
First Posted : December 9, 2015
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
American Medical Center
Information provided by (Responsible Party):
Dr. Andreas Charalambous, Cyprus University of Technology

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

Condition or disease Intervention/treatment Phase
Palmar-Plantar Erythrodysesthesia Device: Vitamin B6 cream Device: Placebo Vitamin B6 cream Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Double Blind Placebo Control Randomised Trial to Test the Effectiveness of Vitamin B6 in Hand Foot Syndrome
Study Start Date : July 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vitamin B6
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
Topical Vitamin B6 cream

Placebo Comparator: Placebo
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
Placebo Vitamin B6 cream




Primary Outcome Measures :
  1. PPE grade [ Time Frame: up to 4 weeks ]
    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 :
  1. Health Related Quality of Life [ Time Frame: up to 4 weeks ]
    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.

  2. Quality of Life in relation to PPE [ Time Frame: up to 4 weeks ]
    This is a quality of life scale specifically for patients experiencing radiation-induced PPE


Other Outcome Measures:
  1. Activities of daily living [ Time Frame: up to 4 weeks ]
    Activities of daily living will be assessed with the Eastern Co-operative Oncology Group (ECOG)/WHO system

  2. Treatment side-effects [ Time Frame: up to 4 weeks ]
    Any possible side-effect due to the treatment will be recorded



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625415


Contacts
Contact: Andreas Charalambous, PhD +35725002011 andreas.charalambous@cut.ac.cy
Contact: Elena Filippou, BSc, MSc (C) 97725755 e.filippou@nup.ac.cy

Locations
Cyprus
Limassol General Hospital Recruiting
Limassol, Cyprus
Contact: Simos Malas, MD    25 801100    Drmalas@hotmail.com   
Contact: Despo Achilleos, RN    25 801100    despinaachilleos@cytanet.com.cy   
American Medical Center Recruiting
Nicosia, Cyprus, 1311
Contact: George Astras, MD, MRCP, MSc(UK)    +357 22 476 636    astras@gmail.com   
Sponsors and Collaborators
Cyprus University of Technology
American Medical Center

Responsible Party: Dr. Andreas Charalambous, Assistant Professor, Cyprus University of Technology
ClinicalTrials.gov Identifier: NCT02625415     History of Changes
Other Study ID Numbers: AC-PPEHP-89
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: February 2017

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Hand-Foot Syndrome
Drug Eruptions
Dermatitis
Skin Diseases
Drug Hypersensitivity
Chemically-Induced Disorders
Vitamins
Vitamin B 6
Pyridoxal
Pyridoxine
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs