Comparison Trial of Chlorinated Polyethylene and Silicone Elastomers for Facial Prostheses - Full Text View

Purpose

Primary Objectives:

Establish a randomized, single-crossover, double-blinded clinical trial at 2 cancer centers to evaluate CPE (experimental) and silicone (Silastic Adhesive A/MDX4-4210)(control) materials for: Non-inferiority of CPE compared to silicone elastomer.
1. Recruit 100 eligible EMFP patients at predefined clinics at M.D. Anderson Cancer Center, University of Texas and Toronto-Sunnybrook Regional Cancer Centre, University of Toronto.
2. Train and calibrate maxillofacial anaplastologists in:
  1. fabricating and delivering to patients the CPE prosthesis and the conventional silicone prosthesis.
  2. One pilot CPE and one pilot silicone prosthesis on 2 patients.
  3. Administer and analyze the Anaplastologist / Dental Laboratory Technician Questionnaire.
3. Train and calibrate clinical evaluators at both centers to administer and analyze:
  1. Clinician-Outgoing,
  2. Clinician-Incoming, and
  3. Patient Evaluation Questionnaires
4. Evaluate delivered 100 prosthesis pairs, each prosthesis successively worn for 4 months each at the 2 cancer centers, to test the non-inferiority of the CPE based on functional and subjective characteristics. Assemble Data and Safety Monitoring Board.
Non-inferiority of the patient quality of life when using the CPE prosthesis when compared to using the silicone prosthesis. The experimental material, CPE, yields a non-inferior quality of life to the patients, compared to silicone elastomers. Administer the Toronto Outcome Measure for Craniofacial Prosthetics to assess the effects of each prosthetic material before and after wearing each prosthesis.
Estimate the longevity of silicone and CPE prostheses beyond the single crossover point.

Condition	Intervention	Phase
Head and Neck Cancer	Device: Chlorinated Polyethylene Prosthesis Device: Silastic Adhesive A/MDX4-4210 Prosthesis Behavioral: Questionnaire	Phase III

MedlinePlus related topics:

Cancer Head and Neck Cancer

ChemIDplus related topics:

Baysilon Polydimethylsiloxane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Multicenter Clinical Trial of CPE for Maxillofacial Prosthetics

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment:	100
Study Start Date:	June 2004

Show Detailed Description

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject must be 21 years of age or older.
Requires treatment for developmental or acquired extraoral facial defect
Fully healed wound (6 months or greater after surgery and or radiation).
Karnofsky score greater than or equal to 60
Subject agrees to wear the prosthesis at least 6 hours per day
Subject agrees to use the prescribed adhesive and to clean and store prosthesis as instructed.
Plans to be able to return to the research institution for a 10 month period.
Subject able to manage prosthesis themselves or with caregiver for a 12 month period.
Cognizant enough to answer questionnaires

Exclusion Criteria:

Defect greater than 9x12 cm (3 1/2 x 4 1/2 inches) in diameter.
Framework or implant/magnet retention
Multiple recurrences of tumor
Hypersensitivity to adhesives or test materials.
Current systemic or topical facial steroid treatment.
Legally blind.
Expected to have further surgeries to defect, radiation therapy, or other cytoreductive therapy over the next 10 months.
Evidence of active skin condition/disease
Infectious risk patient

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408486

Locations


United States, Texas
	U.T.M.D. Anderson Cancer Center
	Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Institutes of Health (NIH)

Investigators


Principal Investigator:	Mark Chambers, MD	U.T.M.D. Anderson Cancer Center

More Information

Study ID Numbers:	2003-0807
First Received:	December 5, 2006
Last Updated:	July 11, 2007
ClinicalTrials.gov Identifier:	NCT00408486
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Head and Neck Cancer

Extraoral Facial Defect

Maxillofacial Prosthetics

Questionnaire

Prosthesis

Silicone

Study placed in the following topic categories:

Facies

Head and Neck Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on August 29, 2008

Sponsors and Collaborators:	M.D. Anderson Cancer Center National Institutes of Health (NIH)
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00408486