Clinical Trial: Testing the Effectiveness of Henna on Managing PPE

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:

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 0, 3, 4 and 5 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.


Sponsor: Cyprus University of Technology

Current Primary Outcome: Change from Baseline PPE Grade at 3,4, 5 weeks [ Time Frame: 3, 4 and 5 weeks ]

The grade of PPE will be assessed with a standardised three-grade system previously used in capecitabine clinical trials


Original Primary Outcome: PPE grade [ Time Frame: up to 12 weeks ]

The grade of PPE will be assessed with a standardised three-grade system previously used in capecitabine clinical trials


Current Secondary Outcome:

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


Original Secondary Outcome: EORTC QOLc30 [ Time Frame: 0,4,8,12 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.


Information By: Cyprus University of Technology

Dates:
Date Received: December 14, 2012
Date Started: December 2014
Date Completion: December 2017
Last Updated: February 10, 2017
Last Verified: February 2017