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

NCT ID: NCT00498992

Last Updated: 2013-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dermatologic Complications Unspecified Adult Solid Tumor, Protocol Specific

Keywords

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dermatologic complications unspecified adult solid tumor, protocol specific

Study Design

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Primary Study Purpose

SUPPORTIVE_CARE

Interventions

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collagen/aloe vera/vitamin E/lidocaine topical hydrogel

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ingalls Memorial Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Mark F. Kozloff, MD

Role: STUDY_CHAIR

Ingalls Memorial Hospital

Locations

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Ingalls Cancer Care Center at Ingalls Memorial Hospital

Harvey, Illinois, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Clinical Trials Office - Ingalls Cancer Care Center at Ingalls

Role: primary

Other Identifiers

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IMH-REG-ING-100

Identifier Type: -

Identifier Source: secondary_id

MPMM-IMH-REG-ING-100

Identifier Type: -

Identifier Source: secondary_id

CDR0000553120

Identifier Type: -

Identifier Source: org_study_id