The Use of Henna and Propolis on PPE
This study is not yet open for participant recruitment.
Verified December 2012 by Cyprus University of Technology
Sponsor:
Cyprus University of Technology
Information provided by (Responsible Party):
Dr. Andreas Charalambous, Cyprus University of Technology
ClinicalTrials.gov Identifier:
NCT01751893
First received: December 14, 2012
Last updated: December 18, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 and propolis treatment protocol in the management of capecitabine and/or pegylated liposomal doxorubicin induced palmar-plantar erythrodysesthesia.
| Condition | Intervention |
|---|---|
|
Palmar-plantar Erythrodysesthesia (PPE) |
Drug: Henna-Propolis Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | A Randomized Double-blind, Placebo-controlled Study of the Effects of a Combination of Propolis and Lawsonia Inermis on Palmar-Plantar Erythrodysesthesia Induced by Capecitabine and/or Pegylated Liposomal Doxorubicin |
Resource links provided by NLM:
Further study details as provided by Cyprus University of Technology:
Primary Outcome Measures:
- PPE grade [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]The grade of PPE will be assessed with a standardised three-grade system previously used in capecitabine clinical trials
Secondary Outcome Measures:
- EORTC QOLc30 [ Time Frame: 0,4,8,12 weeks ] [ Designated as safety issue: No ]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.
Other Outcome Measures:
- Activities of daily living [ Time Frame: 0,4,8,12 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 0,4,8,12 weeks ] [ Designated as safety issue: Yes ]The patients will report any possible side-effect due to the treatment (i.e rash)
| Estimated Enrollment: | 250 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Henna-propolis arm
Based on the treatment protocol for this study the patients will receive the henna and propolis treatment for 12 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 2 hours and then the mixture will be rinsed with fresh water and the propolis (olive oil based) applied.
|
Drug: Henna-Propolis |
|
Placebo Comparator: Placebo
Based on the treatment protocol for this study the patients in this arm will receive the henna and propolis placebo treatment for 12 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 2 hours and then the mixture will be rinsed with fresh water and the propolis (olive oil based) placebo applied.
|
Drug: Placebo |
Detailed Description:
This will be a randomized double-blind, placebo-controlled study with 250 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 0, 4, 8 and 12 weeks. The intervention group will receive the application of henna and propolis 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 or/and honey or/and olive oil.
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751893
Contacts
| Contact: Andreas Charalambous, PhD | +357252011 | andreas.charalambous@cut.ac.cy |
Locations
| Cyprus | |
| Bank of Cyprus Oncology | Not yet recruiting |
| Nicosia, Cyprus, 2006 | |
| Principal Investigator: Michalis Stavrinou, BSc | |
Sponsors and Collaborators
Cyprus University of Technology
More Information
No publications provided
| Responsible Party: | Dr. Andreas Charalambous, Lecturer of Oncology and Palliative Care, Cyprus University of Technology |
| ClinicalTrials.gov Identifier: | NCT01751893 History of Changes |
| Other Study ID Numbers: | AC-PPEHP-88 |
| Study First Received: | December 14, 2012 |
| Last Updated: | December 18, 2012 |
| Health Authority: | Cyprus: Ministry of Health |
Keywords provided by Cyprus University of Technology:
|
Hand-foot syndrome palmar-plantar erythrodysesthesia capecitabine |
pegylated liposomal doxorubicin henna propolis |
Additional relevant MeSH terms:
|
Doxorubicin Capecitabine Lawsone Propolis Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Anti-Infective Agents Antifungal Agents |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Sunscreening Agents Radiation-Protective Agents Protective Agents Physiological Effects of Drugs Dermatologic Agents Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on June 18, 2013