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

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

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 (CPE) Prosthesis Behavioral: Questionnaire Other: Silicone Prostheses	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Parallel Assignment, Safety/Efficacy Study
Official Title:	Multicenter Clinical Trial of CPE for Maxillofacial Prosthetics

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Silicone

U.S. FDA Resources

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

Primary Outcome Measures:

To compare chlorinated polyethylene (CPE) to silicone rubber when used to make facial prostheses for cancer patients in need of reconstructive rehabilitation in order to learn which materials lasts longer and provides better quality of life. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	June 2004
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Active Comparator Participants in the first group will wear the silicone prostheses first and then the CPE prostheses.	Device: Chlorinated Polyethylene (CPE) Prosthesis Group 1: Worn Second Group 2: Worn First Behavioral: Questionnaire Surveys Other: Silicone Prostheses Group 1: Worn First Group 2: Worn Second
Group 2: Active Comparator Participants in the second group will wear the CPE prostheses first and then the silicone prostheses.	Device: Chlorinated Polyethylene (CPE) Prosthesis Group 1: Worn Second Group 2: Worn First Behavioral: Questionnaire Surveys Other: Silicone Prostheses Group 1: Worn First Group 2: Worn Second

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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

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UT MD Anderson Cancer Center ( Mark Chambers, MS, DMD/Professor )
Study ID Numbers:	2003-0807
Study First Received:	December 5, 2006
Last Updated:	May 21, 2009
ClinicalTrials.gov Identifier:	NCT00408486 History of Changes
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
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009