Testing the Effectiveness of Henna on Managing PPE

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Cyprus University of Technology
Sponsor:
Information provided by (Responsible Party):
Dr. Andreas Charalambous, Cyprus University of Technology
ClinicalTrials.gov Identifier:
NCT01751893
First received: December 14, 2012
Last updated: July 27, 2016
Last verified: July 2016
  Purpose
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 Intervention
Palmar-plantar Erythrodysesthesia (PPE)
Drug: Henna
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Cyprus University of Technology:

Primary Outcome Measures:
  • PPE grade [ Time Frame: up to 3 weeks ] [ Designated as safety issue: No ]
    The grade of PPE will be assessed with a standardised three-grade system previously used in capecitabine clinical trials


Secondary Outcome Measures:
  • EORTC QOLc30 [ Time Frame: 3,4,5 weeks ] [ Designated as safety issue: No ]
    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.

  • Hand-foot syndrome 14 (HFS-14) [ Time Frame: 3,4,5 weeks ] [ Designated as safety issue: No ]
    this is a quality of life scale for patients experiencing radiation-induced PPE


Other Outcome Measures:
  • Activities of daily living [ Time Frame: 3,4,5 weeks ] [ Designated as safety issue: No ]
    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: 3,4,5 weeks ] [ Designated as safety issue: Yes ]
    The patients will report any possible side-effect due to the treatment (i.e rash)


Estimated Enrollment: 80
Study Start Date: December 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Henna arm
Based on the treatment protocol for this study the patients will receive the henna treatment for 12 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 2 hours and then the mixture will be rinsed with fresh water.
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 12 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 2 hours and then the mixture will be rinsed with fresh water.
Drug: Placebo

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 0, 4, 8 and 12 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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 or/and honey or/and olive oil.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751893

Contacts
Contact: Andreas Charalambous, PhD +357252011 andreas.charalambous@cut.ac.cy

Locations
Cyprus
Bank of Cyprus Oncology Recruiting
Nicosia, Cyprus, 2006
Principal Investigator: Michalis Stavrinou, BSc         
Sponsors and Collaborators
Cyprus University of Technology
  More Information

Responsible Party: Dr. Andreas Charalambous, Assistant Professor of Oncology and Palliative Care, Cyprus University of Technology
ClinicalTrials.gov Identifier: NCT01751893     History of Changes
Other Study ID Numbers: AC-PPEHP-88 
Study First Received: December 14, 2012
Last Updated: July 27, 2016
Health Authority: Cyprus: Ministry of Health

Keywords provided by 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
Capecitabine
Liposomal doxorubicin
Doxorubicin
Lawsone
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on August 24, 2016