Muscle Composition and Function for Swallowing in Head/Neck Cancer Patients

NCT00796952 | Completed Phase 2

• 1 other identifier: BM009
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Swallowing dysfunction after chemo-radiation is common, but there is no reliable evidence for how it should be managed. This pilot randomized controlled trial evaluated the relative benefit of a battery of isometric / isotonic exercises on the maintenance of muscle composition and function for swallowing in Head / Neck Cancer patients undergoing chemo-radiation therapy.

Conditions

Head & Neck Cancer

Keywords

Head/ neck cancer; Swallowing; behavioral treatment

Outcome Measures

Primary Outcomes (4)

• Oropharyngeal muscle volume and signal intensity measured by T2 weighted MRI

  Baseline, 6 weeks( end of CRT), 6 months(following CRT)

• Level of functional swallowing ability- measured by functional eating score (FOIS), clinical swallowing score, videoendoscopy and videofluoroscopic evaluation

  Baseline, 6 week(end of CRT), 6 months(following CRT)

• Patient perception of swallowing ability

  Baseline, 6 weeks (end of CRT), 6 months (following CRT)

• Quality of Life

  Baseline, 6 weeks (end of CRT), 6 months (following CRT)

Secondary Outcomes (3)

• Taste perception

  Baseline, 6 weeks (end of CRT), 6 months (following CRT)

• Perception of smell

  Baseline, 6 weeks (end of CRT), 6 months (following CRT)

• Salivation rates

  Baseline, 6 weeks (end of CRT), 6 months (following CRT)

Study Arms (3)

Usual Care

ACTIVE COMPARATOR

Patient management by the attending Radiation oncologist "as usual".

Behavioral: focused attention sessions

Pharyngocise

EXPERIMENTAL

Standardized high intensity behavioral swallowing therapy (Pharyngocise) comprised a battery of direct isometric / isotonic exercises and appropriate dietary modification, under the direction of the study speech pathologist, twice daily for the duration of the patient's total course of their chemo-radiation treatment (up to a maximum of 6 weeks)

Behavioral: Pharyngocise

Valchuff

SHAM COMPARATOR

Standardised sham swallowing therapy comprised a buccal extension maneuver ("valchuff") and appropriate dietary modification, under the direction of the study speech pathologist, twice daily each week for the duration of the patient's total course of chemo-radiation treatment.

Behavioral: Valchuff

Interventions

focused attention sessions BEHAVIORAL

Patient management by the attending Radiation oncologist "as usual". Patients assigned to this condition received focused attention sessions during the total course of their CRT treatment from a Speech Language Pathologist, consisting of weekly phone calls to monitor their swallowing outcome during the radiotherapy period.

Usual Care

Valchuff BEHAVIORAL

Standardised sham or placebo swallowing therapy comprised a buccal extension maneuver ("valchuff") and appropriate dietary modification, under the direction of the study speech pathologist, twice daily each week for the duration of the patient's total course of CRT treatment.

Valchuff

Pharyngocise BEHAVIORAL

Standardized high intensity behavioral swallowing therapy (Pharyngocise) comprised a battery of direct isometric / isotonic exercises and appropriate dietary modification, under the direction of the study speech pathologist, twice daily for the duration of the patient's total course of their CRT treatment (up to a maximum of 6 weeks)

Pharyngocise

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Head / neck cancer of the oropharyngeal or adjacent regions, confirmed by clinical history and exam, with positive cross sectional imaging studies and histopathological biopsy excluding other pathology.
• Planned to undergo external beam radiation therapy,
• No previous history of nonoral feeding for cancer related illness,
• Able to undergo MRI procedures.
• Physician / patient agreement to participate

You may not qualify if:

• Planned surgical intervention
• Existence of a co-existing neurological or medical disorder known to cause dysphagia
• Prior radiotherapy or surgery to the head / neck region that could contribute to dysphagia.
• Previous swallowing therapy within four weeks of randomization

Sponsors & Collaborators

• University of Florida: lead
• Florida Department of Health: collaborator

Study Sites (1)

University of Florida, Health Science Center

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Giselle Carnaby-Mann, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Michael Crary, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2008
• First Posted: November 24, 2008
• Study Start: November 1, 2001
• Primary Completion: July 1, 2004
• Study Completion: April 1, 2005
• Last Updated: September 20, 2011

Record last verified: 2011-09

Locations

US (1)