CompletedNot Applicable

Testing the Effectiveness of Henna on Managing PPE

Cyprus56 participantsStarted 2017-06-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline PPE Grade at 3,4, 5,6 weeks

Timeframe: 3, 4, 5 and 6 weeks

Trial details

NCT IDNCT01751893

SponsorCyprus University of Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05-01

View on ClinicalTrials.gov More Palmar-plantar Erythrodysesthesia (PPE) trials