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Completed

NCT Number: NCT01751893

Testing the Effectiveness of Henna on Managing PPE

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.

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Key information

Conditions

Palmar-plantar Erythrodysesthesia (PPE) Chemically-Induced Disorders Dermatitis Drug Eruptions Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions Hand-Foot Syndrome Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American Medical Centre

Nicosia, 2047, Cyprus

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Henna

Drug

natural henna in the form of paste

Placebo

Drug

placebo

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Cyprus University of Technology

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 18, 2012
Registry last updated
Oct 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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