Palmar-Plantar Erythrodysesthesia Clinical Trial
Official title:
A Double Blind Placebo Control Randomised Trial to Test the Effectiveness of Vitamin B6 in Hand Foot Syndrome
The study is designed to test the effectiveness of topical B6 cream in patients that developed Palmar-Plantar Erythrodysesthesia (Hand foot syndrome).
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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F511 Cream in Preventing Palmar-Plantar Erythrodysesthesia in Patients Receiving Doxorubicin Hydrochloride Liposome for Metastatic Breast Cancer
|
Phase 3 | |
| Completed |
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|
Phase 2 | |
| Recruiting |
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|
N/A | |
| Terminated |
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|
Phase 3 | |
| Active, not recruiting |
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|
Phase 3 | |
| Terminated |
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|
Phase 2 | |
| Completed |
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|
Phase 1/Phase 2 |