Testing the Effectiveness of Henna on Managing PPE
Palmar-plantar Erythrodysesthesia (PPE)
About this trial
This is an interventional supportive care trial for Palmar-plantar Erythrodysesthesia (PPE) focused on measuring Hand-foot syndrome, palmar-plantar erythrodysesthesia, capecitabine, pegylated liposomal doxorubicin, henna
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
Sites / Locations
- American Medical Centre
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Henna arm
Placebo
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.
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.