Testing the Effectiveness of Henna on Managing PPE

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

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.

Study Overview

• Status: Completed
• Conditions: Palmar-plantar Erythrodysesthesia (PPE)
• Intervention / Treatment: Drug: Placebo; Drug: Henna

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cyprus
  • Nicosia, Cyprus, 2047
    • American Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Henna arm; 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; natural henna in the form of paste
Placebo Comparator: Placebo; 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; placebo

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Treatment side-effects	The patients will report any possible side-effect due to the treatment (i.e rash)	During the 4 weeks

Collaborators and Investigators

• Sponsor: Cyprus University of Technology

Publications and helpful links

General Publications

• Stavrinou M, Tsitsi T, Astras G, Paikousis L, Charalambous A. A randomised controlled feasibility trial to evaluate Lawsonia inermis (henna)'s effect on palmar-plantar erythrodysesthesia induced by capecitabine or pegylated liposomal doxorubicin. Eur J Oncol Nurs. 2021 Apr;51:101908. doi: 10.1016/j.ejon.2021.101908. Epub 2021 Feb 15.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): June 15, 2018

Study Registration Dates

• First Submitted: December 14, 2012
• First Submitted That Met QC Criteria: December 17, 2012
• First Posted (Estimate): December 18, 2012

Study Record Updates

• Last Update Posted (Actual): October 25, 2019
• Last Update Submitted That Met QC Criteria: October 23, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: capecitabine; Hand-foot syndrome; palmar-plantar erythrodysesthesia; pegylated liposomal doxorubicin; henna
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Skin Diseases; Dermatitis; Drug-Related Side Effects and Adverse Reactions; Drug Eruptions; Drug Hypersensitivity; Hand-Foot Syndrome
• Other Study ID Numbers: AC-PPEHP-88

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No