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 because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Ingalls Memorial Hospital
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00498992
First received: July 10, 2007
Last updated: February 22, 2011
Last verified: July 2009
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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:
Drug Information available for:
alpha-Tocopherol
Lidocaine hydrochloride
Lidocaine
Tocopherol
Vitamin E succinate
Tocopherol acetate
Aloe vera
dl-alpha-Tocopherol
Cetuximab
U.S. FDA Resources
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 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00498992 History of Changes |
| Other Study ID Numbers: | CDR0000553120, IMH-REG-ING-100, MPMM-IMH-REG-ING-100 |
| Study First Received: | July 10, 2007 |
| Last Updated: | February 22, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
dermatologic complications unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Lidocaine Vitamin E Vitamins Cetuximab Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents |
Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Micronutrients Growth Substances Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 16, 2013