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Testing the Effectiveness of Henna on Managing PPE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01751893
Recruitment Status : Completed
First Posted : December 18, 2012
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Andreas Charalambous, Cyprus University of Technology

Tracking Information
First Submitted Date  ICMJE December 14, 2012
First Posted Date  ICMJE December 18, 2012
Last Update Posted Date October 25, 2019
Actual Study Start Date  ICMJE June 1, 2017
Actual Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 17, 2012)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2012)
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.
Current Other Pre-specified Outcome Measures
 (submitted: October 23, 2019)
  • 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
  • Treatment side-effects [ Time Frame: During the 4 weeks ]
    The patients will report any possible side-effect due to the treatment (i.e rash)
Original Other Pre-specified Outcome Measures
 (submitted: December 17, 2012)
  • Activities of daily living [ Time Frame: 0,4,8,12 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
  • Treatment side-effects [ Time Frame: 0,4,8,12 weeks ]
    The patients will report any possible side-effect due to the treatment (i.e rash)
 
Descriptive Information
Brief Title  ICMJE Testing the Effectiveness of Henna on Managing PPE
Official Title  ICMJE 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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Palmar-plantar Erythrodysesthesia (PPE)
Intervention  ICMJE
  • Drug: Henna
    natural henna in the form of paste
  • Drug: Placebo
    placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Henna
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2018)
56
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2012)
250
Actual Study Completion Date  ICMJE June 15, 2018
Actual Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Cyprus
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01751893
Other Study ID Numbers  ICMJE AC-PPEHP-88
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Andreas Charalambous, Cyprus University of Technology
Study Sponsor  ICMJE Cyprus University of Technology
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cyprus University of Technology
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP