Testing the Effectiveness of Henna on Managing PPE
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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|
- Change from Baseline PPE Grade at 3,4, 5 weeks [ Time Frame: 3, 4 and 5 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 weeks [ Time Frame: 3, 4 and 5 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 weeks [ Time Frame: 3, 4 and 5 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 weeks [ Time Frame: 3, 4 and 5 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 5 weeks ]The patients will report any possible side-effect due to the treatment (i.e rash)
|Study Start Date:||December 2014|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
Experimental: Henna arm
Based on the treatment protocol for this study the patients will receive the henna treatment for 5 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 2 hours and then the mixture will be rinsed with fresh water.
Placebo Comparator: Placebo
Based on the treatment protocol for this study the patients in this arm will receive the henna placebo treatment for 5 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 2 hours and then the mixture will be rinsed with fresh water.
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 0, 3, 4 and 5 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751893
|Contact: Andreas Charalambous, PhDfirstname.lastname@example.org|
|Bank of Cyprus Oncology||Recruiting|
|Nicosia, Cyprus, 2006|
|Principal Investigator: Michalis Stavrinou, BSc|