Testing the Effectiveness of Henna on Managing PPE

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Palmar-plantar Erythrodysesthesia (PPE)

Intervention / Treatment
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* Drug: Henna
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Henna arm<br>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. | Drug: Henna<br>* natural henna in the form of paste<br>|
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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henna, Hand-foot syndrome, palmar-plantar erythrodysesthesia, capecitabine, pegylated liposomal doxorubicin