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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Change from Baseline PPE Grade at 3,4, 5,6 weeks
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Drug)
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 (Drug)
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)
Investigators
Dr. Andreas Charalambous
Associate Professor of Oncology and Palliative Care
Cyprus University of Technology