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
Overview
- Phase
- Not Applicable
- Intervention
- Henna
- Conditions
- Palmar-plantar Erythrodysesthesia (PPE)
- Sponsor
- Cyprus University of Technology
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Change from Baseline PPE Grade at 3,4, 5,6 weeks
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Dr. Andreas Charalambous
Associate Professor of Oncology and Palliative Care
Cyprus University of Technology
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Henna
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.
Intervention: Placebo
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Change from Baseline EORTC QOLc30 at 3,4, 5,6 weeks(3, 4,5 and 6 weeks)
- Change from Baseline Hand-foot syndrome 14 (HFS-14) at 3,4,5,6 weeks(3, 4, 5 and 6 weeks)