Palmar-plantar Erythrodysesthesia (PPE) Clinical Trial
Official title:
A Randomized Double-blind, Placebo-controlled Study of the Effects of Lawsonia Inermis on Palmar-Plantar Erythrodysesthesia Induced by Capecitabine and/or Pegylated Liposomal Doxorubicin
The palmar-plantar erythrodysesthesia (PPE) is the only clinical adverse event that commonly occurs with capecitabine and/or pegylated liposomal doxorubicin treatment and it warrants special attention because it is the most common dose-limiting toxicity. this study is designed to test the effectiveness of a henna treatment protocol in the management of capecitabine and/or pegylated liposomal doxorubicin induced palmar-plantar erythrodysesthesia.
This will be a randomized double-blind, placebo-controlled study with 80 cancer patients that
will receive chemotherapy treatment with capecitabine and/or pegylated liposomal doxorubicin.
The selection of potential participants will be based on pre-determined inclusion and
exclusion criteria. Patients will be randomly allocated either to the treatment group or the
placebo group. Treatment will be delivered twice a week and assessments will take place at 2,
3, 4, 5 and 6 weeks.
The intervention group will receive the application of henna 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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