Testing the Effectiveness of Henna on Managing PPE
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|ClinicalTrials.gov Identifier: NCT01751893|
Recruitment Status : Completed
First Posted : December 18, 2012
Last Update Posted : October 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Palmar-plantar Erythrodysesthesia (PPE)||Drug: Henna Drug: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||June 1, 2017|
|Actual Primary Completion Date :||May 1, 2018|
|Actual Study Completion Date :||June 15, 2018|
Experimental: Henna arm
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.
natural henna in the form of paste
Placebo Comparator: Placebo
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.
- Change from Baseline PPE Grade at 3,4, 5,6 weeks [ Time Frame: 3, 4, 5 and 6 weeks ]The grade of PPE will be assessed with a standardised three-grade system previously used in capecitabine clinical trials
- Change from Baseline EORTC QOLc30 at 3,4, 5,6 weeks [ Time Frame: 3, 4,5 and 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.
- Change from Baseline Hand-foot syndrome 14 (HFS-14) at 3,4,5,6 weeks [ Time Frame: 3, 4, 5 and 6 weeks ]this is a quality of life scale for patients experiencing radiation-induced PPE
- Change from Baseline Activities of daily living at 3,4,5,6 weeks [ Time Frame: 3, 4, 5 and 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
- Treatment side-effects [ Time Frame: During the 4 weeks ]The patients will report any possible side-effect due to the treatment (i.e rash)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751893
|American Medical Centre|
|Nicosia, Cyprus, 2047|