Improving Therapeutic Outcomes in the Tongue Carcinoma Patient: Assessment of Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging

NCT00594724 | Completed DMC

• 1 other identifier: 02-093
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see how the brain re-learns to control the tongue in speaking and swallowing when either portions of the tongue have been removed, or when the tongue has been treated with radiation, in order to treat cancer. We hope the results of this study will help us to improve healing for patients who are being treated for cancer of the tongue. When patients with cancer of the tongue are treated by removing parts of the tongue (surgery) or by destroying the cancer with radiation to the tongue, they have significant difficulty speaking and swallowing after such treatments. At this time, patients who have been treated for cancer of the tongue re-learn speaking and swallowing through exercises taught by a speech pathologist. What is needed is information on how the brain re-learns to control speaking and swallowing so that we can help these patients re-learn faster after their treatments.

Conditions

Tongue Carcinoma

Keywords

Tongue; Carcinoma; Cancer; 02-093

Outcome Measures

Primary Outcomes (1)

• To utilize fMRI to characterize adaptation to alterations in tongue morphology & function following either surgical therapy, or radiation/chemotherapy to tongue in patients undergoing treatment of malignancies involving the tongue.

  7 years

Secondary Outcomes (3)

• Determine relationship between mechanisms of adaptation at level of central nervous system to alterations in function in the tongue.

  7 years

• Determine changes in cortical activity in representation of tongue movement that occur pre and post-treatment.

  7 years

• Determine the central neural response to direct peripheral rehabilitation strategies.

  conclusion of study

Study Arms (1)

1

EXPERIMENTAL

Procedure: MRI

Interventions

MRI PROCEDURE

Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging

1

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary malignancy of the oral or base of tongue, Stage I-IV of AJCC staging system, planned for surgical or radiation therapy.
• Healthy adult subjects between the ages of 21-75 years.

You may not qualify if:

• History of significant psychiatric condition (e.g. schizophrenia, obsessive-compulsive disorder, significant dementia),
• History of the following neurological conditions: CVA, seizure disorders, demyelinating conditions, systemic neuromuscular disorders, cerebral palsy, Alzheimer's disease.
• History of previous moderate to severe traumatic brain injury.
• History of significant cardiovascular, respiratory, gastrointestinal or renal disease (e.g.myocardial infarction within the previous 12 months, significant vaso-occlusive disease,severe or advanced asthma, COPD, emphysema, gastroesophageal reflux disease, or renal compromise)
• History of achalasia
• History of other neoplasms involving the brain, head and neck, or gastrointestinal system.
• History of dysphagia, odynophagia, or aphasia unrelated to present illness.
• History of significant claustrophobic reactions.
• Standard contraindications to MR examinations (e.g. implanted stimulators).
• Carcinoma patients and additionally includes history of significant surgery or previous radiation therapy to the head and neck
• Previous history of dysphagia, odynophagia, aphasia, pregnancy,and standard contraindications to MR examinations.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Rockefeller University: collaborator
• New York Presbyterian Hospital: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Tongue Neoplasms; Carcinoma; Neoplasms

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Kyung Peck, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: November 1, 2002
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 12, 2014

Record last verified: 2014-06

Locations

US (1)