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

Completed · Not applicable

Conditions studied: Tongue Carcinoma

In brief

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.

Key facts

Study ID

NCT00594724

Run by

Memorial Sloan Kettering Cancer Center

People needed

99

Starts

2002-11-01

Expected to finish

2014-06-01

Last updated by the study team

2014-06-12

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• Exclusion criteria for the tongue carcinoma patients include the following:
• 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).
• Exclusion criteria for the healthy subjects includes the all of the conditions listed for the tongue:
• 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.

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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