Palmar-Plantar Erythrodysesthesia
Conditions
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.
Interventions
DEVICEVitamin B6 cream
Topical Vitamin B6 cream
DEVICEPlacebo Vitamin B6 cream
Placebo Vitamin B6 cream
Sponsors
American Medical Center
Cyprus University of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PPE grade | 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
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life | 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 | up to 4 weeks | This is a quality of life scale specifically for patients experiencing radiation-induced PPE |
Other
| Measure | Time frame | Description |
|---|---|---|
| Activities of daily living | up to 4 weeks | Activities of daily living will be assessed with the Eastern Co-operative Oncology Group (ECOG)/WHO system |
| Treatment side-effects | up to 4 weeks | Any possible side-effect due to the treatment will be recorded |
Countries
Cyprus
Outcome results
None listed