Testing the Effectiveness of Henna on Managing PPE
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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|
- PPE grade [ Time Frame: up to 3 weeks ] [ Designated as safety issue: No ]The grade of PPE will be assessed with a standardised three-grade system previously used in capecitabine clinical trials
- EORTC QOLc30 [ Time Frame: 3,4,5 weeks ] [ Designated as safety issue: No ]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.
- Hand-foot syndrome 14 (HFS-14) [ Time Frame: 3,4,5 weeks ] [ Designated as safety issue: No ]this is a quality of life scale for patients experiencing radiation-induced PPE
- Activities of daily living [ Time Frame: 3,4,5 weeks ] [ Designated as safety issue: No ]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: 3,4,5 weeks ] [ Designated as safety issue: Yes ]The patients will report any possible side-effect due to the treatment (i.e rash)
|Study Start Date:||December 2014|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||June 2015 (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 12 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 12 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, 4, 8 and 12 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, PhDemail@example.com|
|Bank of Cyprus Oncology||Not yet recruiting|
|Nicosia, Cyprus, 2006|
|Principal Investigator: Michalis Stavrinou, BSc|