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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Henna arm | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Henna | Drug | natural henna in the form of paste |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3, 4, 5 and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3, 4,5 and 6 weeks |
| Change from Baseline Hand-foot syndrome 14 (HFS-14) at 3,4,5,6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3, 4, 5 and 6 weeks |
| Treatment side-effects |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Medical Centre | Nicosia | 2047 | Cyprus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33626423 | Derived | Stavrinou M, Tsitsi T, Astras G, Paikousis L, Charalambous A. A randomised controlled feasibility trial to evaluate Lawsonia inermis (henna)'s effect on palmar-plantar erythrodysesthesia induced by capecitabine or pegylated liposomal doxorubicin. Eur J Oncol Nurs. 2021 Apr;51:101908. doi: 10.1016/j.ejon.2021.101908. Epub 2021 Feb 15. |
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| ID | Term |
|---|---|
| D060831 | Hand-Foot Syndrome |
| ID | Term |
|---|---|
| D003875 | Drug Eruptions |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C005090 | lawsone |
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| Drug |
placebo |
|
this is a quality of life scale for patients experiencing radiation-induced PPE |
| 3, 4, 5 and 6 weeks |
The patients will report any possible side-effect due to the treatment (i.e rash) |
| During the 4 weeks |
| D004342 |
| Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |