Testing the Effectiveness of Henna on Managing PPE

Cyprus University of Technology56 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Palmar-plantar Erythrodysesthesia (PPE)

Interventions

HennaDRUG

natural henna in the form of paste

PlaceboDRUG

placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

American Medical Centre

Nicosia, Cyprus

Outcomes

Primary Outcomes

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

Time frame: 3, 4, 5 and 6 weeks

Secondary Outcomes

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.

Time frame: 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

Time frame: 3, 4, 5 and 6 weeks

Data from ClinicalTrials.gov

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