Testing the Effectiveness of Henna on Managing PPE

NCT01751893 | Completed DMC

• 1 other identifier: AC-PPEHP-88
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Palmar-plantar Erythrodysesthesia (PPE)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from Baseline EORTC QOLc30 at 3,4, 5,6 weeks

  3, 4,5 and 6 weeks

• Change from Baseline Hand-foot syndrome 14 (HFS-14) at 3,4,5,6 weeks

  3, 4, 5 and 6 weeks

Other Outcomes (2)

• Change from Baseline Activities of daily living at 3,4,5,6 weeks

  3, 4, 5 and 6 weeks

• Treatment side-effects

  During the 4 weeks

Study Arms (2)

Henna arm

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Henna DRUG

natural henna in the form of paste

Henna arm

Placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cyprus University of Technology: lead

Study Sites (1)

American Medical Centre

Nicosia, 2047, Cyprus

Location

Related Publications (1)

• 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.

  PMID: 33626423 DERIVED

MeSH Terms

Conditions

Hand-Foot Syndrome

Interventions

lawsone

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Oncology and Palliative Care

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 18, 2012
• Study Start: June 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: June 15, 2018
• Last Updated: October 25, 2019

Record last verified: 2019-10

Locations

CY (1)