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Regenecare® Wound Gel in Treating Rash in Patients Receiving Cetuximab or Other Epidermal Growth Factor Receptor Inhibitor Therapy for Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00498992
First Posted: July 11, 2007
Last Update Posted: September 20, 2013
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.
Information provided by:
National Cancer Institute (NCI)
  Purpose

RATIONALE: Regenecare® wound gel may help relieve pain and itching in patients who develop an acne-like rash while undergoing treatment with cetuximab or another epidermal growth factor receptor inhibitor for cancer.

PURPOSE: This clinical trial is studying how well Regenecare® wound gel works in treating rash in patients receiving cetuximab or another epidermal growth factor receptor inhibitor therapy for cancer.


Condition Intervention
Dermatologic Complications Unspecified Adult Solid Tumor, Protocol Specific Dietary Supplement: collagen/aloe vera/vitamin E/lidocaine topical hydrogel

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
Official Title: Regenecare® in the Treatment of Skin Rash Associated With Cetuximab (Erbitux®) or Other EGFR Treated Cancer Patients

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Efficacy of Regenecare® wound gel, in terms of alleviating pain and itching

Secondary Outcome Measures:
  • Efficacy of Regenecare® wound gel, in terms of reducing severity, redness, and appearance of rash
  • Tolerability of Regenecare® wound gel as assessed by NCI CTCAE v3.0

Estimated Enrollment: 20
Study Start Date: July 2006
Detailed Description:

OBJECTIVES:

Primary

  • Determine the efficacy of Regenecare® wound gel in alleviating pain and itching in patients who develop an acneiform rash while undergoing treatment with cetuximab or other EGFR inhibitor therapy for cancer.

Secondary

  • Determine the efficacy of this drug in reducing the severity of rash in these patients.
  • Determine the efficacy of this drug in reducing the redness and appearance of the rash in these patients.
  • Determine the tolerability of this drug in these patients.

OUTLINE: This is a prospective study.

  • Observation: Patients undergo evaluation by full-face photography prior to development of skin rash (baseline). While undergoing concurrent cancer therapy, patients self-monitor for the appearance of an acneiform rash. Upon initial onset of rash, patients proceed to treatment.
  • Treatment: Patients apply topical Regenecare® wound gel to the face ≥ 4 times daily. Treatment continues for 4 weeks in the absence of unacceptable toxicity.

Patients are evaluated weekly by facial examination, full-face photography, and patient satisfaction questionnaires.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer
  • Starting treatment with cetuximab or other EGFR inhibitor (e.g., erlotinib hydrochloride) on another clinical trial

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • No known history of hypersensitivity to amine-type local anesthetics or to other components of MPM Regenecare® wound gel
  • No other concurrent, serious skin disorders (i.e., scleroderma or psoriasis) that would interfere with assessment of EGFR inhibitor-induced rash

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No other concurrent topical facial creams or lotions
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00498992


Locations
United States, Illinois
Ingalls Cancer Care Center at Ingalls Memorial Hospital Recruiting
Harvey, Illinois, United States, 60426
Contact: Clinical Trials Office - Ingalls Cancer Care Center at Ingalls    708-915-4673      
Sponsors and Collaborators
Ingalls Memorial Hospital
Investigators
Study Chair: Mark F. Kozloff, MD Ingalls Memorial Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00498992     History of Changes
Other Study ID Numbers: CDR0000553120
IMH-REG-ING-100
MPMM-IMH-REG-ING-100
First Submitted: July 10, 2007
First Posted: July 11, 2007
Last Update Posted: September 20, 2013
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
dermatologic complications
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Lidocaine
Cetuximab
Vitamin E
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antioxidants
Protective Agents
Vitamins
Micronutrients
Growth Substances