Testing the Effectiveness of Henna on Managing PPE
- Conditions
- Palmar-plantar Erythrodysesthesia (PPE)
- Interventions
- Drug: Placebo
- Registration Number
- NCT01751893
- Lead Sponsor
- Cyprus University of Technology
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- Adult cancer patients (>18)
- Patients receiving capecitabine and/or PLD as monotherapy or in combination with other agents
- Patients that will experience PPE grade 1 or above
- Willing to participate
- Ability to complete the psychometric assessments.
- A performance status of two or less on the Eastern Cooperative Oncology Group (ECOG)
- Patients with hypersensitivity to natural henna.
- Patients with pre-existing dermatological condition affecting the hands or feet that may limit the interpretation of results
- Patients on Pyridoxine or nicotine patches
- Patients with a previous history of PPE
- Patients whose chemotherapy was discontinued for more than a week
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Henna arm Henna 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 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.
- Primary Outcome Measures
Name Time Method Change from Baseline PPE Grade at 3,4, 5,6 weeks 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
- Secondary Outcome Measures
Name Time Method Change from Baseline EORTC QOLc30 at 3,4, 5,6 weeks 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 3, 4, 5 and 6 weeks this is a quality of life scale for patients experiencing radiation-induced PPE
Trial Locations
- Locations (1)
American Medical Centre
🇨🇾Nicosia, Cyprus