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
|Condition or disease||Intervention/treatment||Phase|
|Palmar-Plantar Erythrodysesthesia||Device: Vitamin B6 cream Device: Placebo Vitamin B6 cream||Not Applicable|
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|
|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|
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
- 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)
- 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.
- 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
- 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
- Treatment side-effects [ Time Frame: up to 4 weeks ]Any possible side-effect due to the treatment will be recorded
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
|Contact: Andreas Charalambous, PhDemail@example.com|
|Contact: Elena Filippou, BSc, MSc (C)||firstname.lastname@example.org|
|Limassol General Hospital||Recruiting|
|Contact: Simos Malas, MD 25 801100 Drmalas@hotmail.com|
|Contact: Despo Achilleos, RN 25 801100 email@example.com|
|American Medical Center||Recruiting|
|Nicosia, Cyprus, 1311|
|Contact: George Astras, MD, MRCP, MSc(UK) +357 22 476 636 firstname.lastname@example.org|