Palmar-plantar Erythrodysesthesia (PPE)
Conditions
Keywords
Hand-foot syndrome, palmar-plantar erythrodysesthesia, capecitabine, pegylated liposomal doxorubicin, henna
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.
Interventions
DRUGHenna
natural henna in the form of paste
DRUGPlacebo
placebo
Sponsors
Cyprus University of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Activities of daily living at 3,4,5,6 weeks | 3, 4, 5 and 6 weeks | The ability of the patients to respond to their activities of daily living will be assessed with the Eastern Co-operative Oncology Group (ECOG)/WHO system |
| Treatment side-effects | During the 4 weeks | The patients will report any possible side-effect due to the treatment (i.e rash) |
Countries
Cyprus
Outcome results
None listed