Palmar-plantar Erythrodysesthesia (PPE) Clinical Trial
Official title:
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
| NCT number | NCT01751893 |
| Other study ID # | AC-PPEHP-88 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 1, 2017 |
| Est. completion date | June 15, 2018 |
| Verified date | October 2019 |
| Source | Cyprus University of Technology |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 56 |
| Est. completion date | June 15, 2018 |
| Est. primary completion date | May 1, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Cyprus | American Medical Centre | Nicosia |
| Lead Sponsor | Collaborator |
|---|---|
| Cyprus University of Technology |
Cyprus,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change from Baseline Activities of daily living at 3,4,5,6 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 | 3, 4, 5 and 6 weeks | |
| Other | Treatment side-effects | The patients will report any possible side-effect due to the treatment (i.e rash) | During the 4 weeks | |
| Primary | Change from Baseline PPE Grade at 3,4, 5,6 weeks | The grade of PPE will be assessed with a standardised three-grade system previously used in capecitabine clinical trials | 3, 4, 5 and 6 weeks | |
| Secondary | Change from Baseline EORTC QOLc30 at 3,4, 5,6 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. | 3, 4,5 and 6 weeks | |
| Secondary | Change from Baseline Hand-foot syndrome 14 (HFS-14) at 3,4,5,6 weeks | this is a quality of life scale for patients experiencing radiation-induced PPE | 3, 4, 5 and 6 weeks |