Pharyngocise Dose Response Study

NCT01279837 | Completed Phase 2

• 1 other identifier: RSG-06-103-01(CCE)
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

In this study supported by an American Cancer Society grant, the investigators are evaluating two levels of swallowing exercise intensity on the maintenance of swallowing muscles and their function in Head/Neck cancer patients undergoing radiotherapy. Patients in this study are randomly placed into different exercise groups and provided with exercises to perform daily during their radiation treatment. Their progress, diet management and swallowing ability are monitored throughout the treatment period and followed up until 3 months after radiation treatment. In addition to the daily treatment details, the patients perception of their swallowing ability and concerns about their health and treatment are also measured. This clinical trial will help to refine a previously investigated simple exercise package and provide a program of intervention that can help prevent medically related complications of swallowing difficulty (e.g. pneumonia, dehydration, prolonged tube feeding), and improve the ability to eat for patients with head / neck cancer. Ultimately it is hoped that this form of exercise therapy will help reduce the costs (personal and financial) to the patient, caregivers and community.

Conditions

Dysphagia

Keywords

swallowing disorders; swallowing therapy; head neck cancer; oropharyngeal dysphagia

Outcome Measures

Primary Outcomes (2)

• Change in T2 Weighted Magnetic Resonance Imaging

  T2 Weighted Magnetic Resonance Imaging (MRI) to quantify baseline muscle parameters in the oral cavity and pharynx. The regions of interest will be identified on images using axial and coronal planes. Information regarding the muscle volume, composition (fat Vs muscle Vs edema) as reflected by the signal intensity.

  at 3 months after treatment

• Clinical swallowing Ability

  Swallowing ability and method/ type of dietary intake, e.g. Functional Oral Intake Scale score \[F.O.I.S\] over the study period

  baseline, 3 weeks, 6 weeks and 3 months post treatment

Secondary Outcomes (4)

• Weight

  baseline, 3 weeks, 6 weeks and 3 months post treatment

• Psychosocial functioning

  baseline and 3 months post treatment

• Instrumental swallowing evaluation

  baseline and 3 months post treatment

• Swallowing Quality of Life

  baseline and 3 months post treatment

Study Arms (3)

Usual care

NO INTERVENTION

Control (Usual care) group in which patients will receive swallowing and prescribed dietary intervention during the radiotherapy period prescribed by the attending physician.

High Intensity Pharyngocise

EXPERIMENTAL

Patients receive twice daily swallowing intervention by a speech language pathologist, consisting of the battery of isometric / isotonic exercises.

Behavioral: Pharyngocise

Low Intensity Pharyngocise

ACTIVE COMPARATOR

Patients will receive a one time only swallowing intervention session by a speech language pathologist, instructing them in the battery of isometric / isotonic exercises plus a home practice instruction digital video tape to support self directed practice of this program at home.

Behavioral: Pharyngocise

Interventions

Pharyngocise BEHAVIORAL

swallowing intervention by a speech language pathologist, consisting of the battery of isometric / isotonic exercises

High Intensity Pharyngocise; Low Intensity 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 external beam radiation therapy
• No previous history of non-oral feeding for cancer related illness
• Able to undergo MRI imaging scan
• Patient and physician agreement to enter the study

You may not qualify if:

• Planned extensive 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
• Gross tumor involvement of the oral and pharyngeal muscles obviating adequate MRI measurements of the majority of muscles of interest.

Sponsors & Collaborators

• University of Florida: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Shands Cancer Center, University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Deglutition Disorders; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Neoplasms by Site; Neoplasms

Study Officials

• Giselle Carnaby-Mann, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 19, 2011
• Study Start: June 1, 2006
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 5, 2012

Record last verified: 2011-01

Locations

US (1)