An interventional study of Henna and Placebo in Palmar-plantar Erythrodysesthesia (PPE), sponsored by Cyprus University of Technology. Completed at 1 site in Cyprus. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-25.
Sponsored by Cyprus University of Technology · Not applicable, Interventional, and Supportive care
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.
45 studies on the registry are indexed under Hand-Foot Syndrome; 9 are open to participants now.
This study's enrollment of 56 is close to the median of 60 across 36 interventional studies indexed under Hand-Foot Syndrome.
Browse Hand-Foot Syndrome studies →Cyprus University of Technology is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Based on the treatment protocol for this study the patients will receive the henna treatment for 4 weeks (supervised treatment for first week and then unsupervised sessions twice a week). The treatment will include the application of the henna mixture (paste) (40gr natural henna and 40ml of purified water) to the affected areas (feet or/and hands) and wear socks or/and gloves. The treatment session will last for 1 hour and then the mixture will be rinsed with fresh water.
Drug: Henna
Based on the treatment protocol for this study the patients in this arm will receive the henna placebo treatment for 4 weeks (supervised treatment for first week and then unsupervised sessions twice a week). The treatment will include the application of the henna placebo mixture (paste) (40gr placebo henna and 40ml of purified water) to the affected areas (feet or/and hands) and wear socks or/and gloves. The treatment session will last for 1 hours and then the mixture will be rinsed with fresh water.
Drug: Placebo
natural henna in the form of paste
placebo
Change from Baseline PPE Grade at 3,4, 5,6 weeks
The grade of PPE will be assessed with a standardised three-grade system previously used in capecitabine clinical trials
Time frame: 3, 4, 5 and 6 weeks
Change from Baseline EORTC QOLc30 at 3,4, 5,6 weeks
The quality of life of the patients will be assessed with the EORTC QOLc30 module which has been developed and validated explicitly for patients suffering from cancer.
Time frame: 3, 4,5 and 6 weeks
Change from Baseline Hand-foot syndrome 14 (HFS-14) at 3,4,5,6 weeks
this is a quality of life scale for patients experiencing radiation-induced PPE
Time frame: 3, 4, 5 and 6 weeks
Change from Baseline Activities of daily living at 3,4,5,6 weeks
The ability of the patients to respond to their activities of daily living will be assessed with the Eastern Co-operative Oncology Group (ECOG)/WHO system
Time frame: 3, 4, 5 and 6 weeks
Treatment side-effects
The patients will report any possible side-effect due to the treatment (i.e rash)
Time frame: During the 4 weeks
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Cyprus University of Technology