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

Tongue Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594724
• Other study ID #: 02-093
• Status: Completed
• Phase: N/A
• First received: January 7, 2008
• Last updated: June 11, 2014
• Start date: November 2002
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

The purpose of this investigation is to determine cortical mechanisms of adaptation to surgical or radiation treatment to the tongue. This study will use a non-invasive imaging technique, Functional Magnetic Resonance Imaging (fMRI), to investigate cortical responses to partial glossectomy or radiation therapy for treatment of a tongue malignancy. Patients with Stage I-IV (AJCC) malignancies of the tongue who are treated with surgery and or radiation therapy will be imaged using fMRI pre-operatively and at approximately six months postoperatively.

Patterns of brain activity from the fMRI studies will be compared with matched healthy control subjects. The results of this investigation will provide needed information on both central and peripheral mechanisms of adaptation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma
• Tongue Carcinoma
• Tongue Neoplasms

Intervention

Procedure:
• MRI
Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	New York Presbyterian Hospital, Rockefeller University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Determine relationship between mechanisms of adaptation at level of central nervous system to alterations in function in the tongue.		7 years	No
Secondary	Determine changes in cortical activity in representation of tongue movement that occur pre and post-treatment.		7 years	No
Secondary	Determine the central neural response to direct peripheral rehabilitation strategies.		conclusion of study	No

External Links

•   Memorial Sloan-Kettering Cancer Center