NCT00214305

Brief Summary

Treatment for head and neck cancer often results in significant swallowing problems because of reduced range of motion (ROM) of the larynx, tongue base, and pharyngeal walls. Our question is: Is swallowing therapy to improve ROM during swallowing maneuvers efficacious in patients with reduced ROM?

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

October 2, 2015

Status Verified

September 1, 2015

First QC Date

September 13, 2005

Last Update Submit

September 30, 2015

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • improved swallowing function

    1-month, 4-month, 6-month, and 12-month post treatment

Secondary Outcomes (3)

  • significantly more oral intake

    1-month, 4-month, 6-month, and 12-month post treatment

  • a less restricted diet

    1-month, 4-month, 6-month, and 12-month post treatment

  • less cost for medically needed services

    1-month, 4-month, 6-month, and 12-month post treatment

Study Arms (2)

Range of Motion Therapy Program

EXPERIMENTAL

The program involves exercises and maneuvers that include voluntary maximal movements of the tongue, pitch range exercises, head lifting (Shaker exercise), resistance to laryngeal excursion (Mendelsohn Maneuver), breath holding after swallow and cough, thermal-tactile stimulation (ice), suck-swallow, optimal posturing, and dietary changes.

Behavioral: Range of Motion Therapy Program

Postural Sensory Therapy Program

PLACEBO COMPARATOR

The program involves all of the above, except that range of motion exercises (voluntary maximal movements of the tongue, pitch range exercises, head lifting, resistance to laryngeal excursion, breath holding after swallow and cough) are not performed.

Behavioral: Postural Sensory Therapy Program

Interventions

Range of Motion Therapy ProgramBEHAVIORAL

The program involves exercises and maneuvers that include voluntary maximal movements of the tongue, pitch range exercises, head lifting (Shaker exercise), resistance to laryngeal excursion (Mendelsohn Maneuver), breath holding after swallow and cough, thermal-tactile stimulation (ice), suck-swallow, optimal posturing, and dietary changes.

Range of Motion Therapy Program
Postural Sensory Therapy ProgramBEHAVIORAL

The program involves all of the above, except that range of motion exercises (voluntary maximal movements of the tongue, pitch range exercises, head lifting, resistance to laryngeal excursion, breath holding after swallow and cough) are not performed.

Postural Sensory Therapy Program

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject have undergone treatment for the head and neck cancer in the form of chemoradiation, and/or one of the following specific types of head and neck cancer surgery: supraglottic laryngectomy, anterior resection with primary or skin graft closure, anterior resection with distal or free flap closure, posterior resection with primary or skin graft closure, or posterior resection with distal or free flap
  • Potential subjects must have been diagnosed with Stage I-IV disease

You may not qualify if:

  • history of medical problems that may affect swallowing, speech, voice
  • neurological problems
  • gastroenterological problems
  • prior treatment for cancer of the head and neck
  • patient who received a total laryngectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Diane Bless, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

August 1, 2005

Last Updated

October 2, 2015

Record last verified: 2015-09

Locations

US(1)