Testing the Effectiveness of Henna on Managing PPE

• ClinicalTrials.gov Identifier: NCT01751893
• Recruitment Status: Completed
• First Posted: December 18, 2012
• Last Update Posted: October 25, 2019
• Sponsor: Cyprus University of Technology
• Information provided by (Responsible Party): Dr. Andreas Charalambous, Cyprus University of Technology

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Palmar-plantar Erythrodysesthesia (PPE)	Drug: Henna; Drug: Placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: June 1, 2017
• Actual Primary Completion Date: May 1, 2018
• Actual Study Completion Date: June 15, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change from Baseline PPE Grade at 3,4, 5,6 weeks [ Time Frame: 3, 4, 5 and 6 weeks ]
   The grade of PPE will be assessed with a standardised three-grade system previously used in capecitabine clinical trials

Secondary Outcome Measures :

1. Change from Baseline EORTC QOLc30 at 3,4, 5,6 weeks [ Time Frame: 3, 4,5 and 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.
2. Change from Baseline Hand-foot syndrome 14 (HFS-14) at 3,4,5,6 weeks [ Time Frame: 3, 4, 5 and 6 weeks ]
   this is a quality of life scale for patients experiencing radiation-induced PPE

Other Outcome Measures:

1. Change from Baseline Activities of daily living at 3,4,5,6 weeks [ Time Frame: 3, 4, 5 and 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
2. Treatment side-effects [ Time Frame: During the 4 weeks ]
   The patients will report any possible side-effect due to the treatment (i.e rash)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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.
• 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

Locations

Cyprus

American Medical Centre

Nicosia, Cyprus, 2047

Sponsors and Collaborators

Cyprus University of Technology

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Dr. Andreas Charalambous, Associate Professor of Oncology and Palliative Care, Cyprus University of Technology
• ClinicalTrials.gov Identifier: NCT01751893
• Other Study ID Numbers: AC-PPEHP-88
• First Posted: December 18, 2012
• Last Update Posted: October 25, 2019
• Last Verified: October 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Andreas Charalambous, Cyprus University of Technology:

Hand-foot syndrome; palmar-plantar erythrodysesthesia; capecitabine; pegylated liposomal doxorubicin; henna

Additional relevant MeSH terms:

Hand-Foot Syndrome; Drug Eruptions; Dermatitis; Skin Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders