Effects of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer

NCT01053546 | Terminated DMC

• 3 other identifiers: IRB00010437NCI-2009-01445CCCWFU 98109
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Swallowing exercise therapy may improve the quality of life of head and neck cancer patients undergoing chemotherapy or radiation therapy. PURPOSE: This randomized phase III trial is studying early onset of swallowing exercise therapy to see how well it works compared to late onset of swallowing exercise therapy in treating patients with head and neck cancer undergoing chemotherapy or radiation therapy.

Conditions

Head and Neck Cancer; Stage I Hypopharyngeal Cancer; Stage I Laryngeal Cancer; Stage I Oropharyngeal Cancer; Stage II Hypopharyngeal Cancer; Stage II Laryngeal Cancer; Stage II Oropharyngeal Cancer; Stage III Hypopharyngeal Cancer; Stage III Laryngeal Cancer; Stage III Oropharyngeal Cancer; Stage IV Hypopharyngeal Cancer; Stage IV Laryngeal Cancer; Stage IV Oropharyngeal Cancer

Outcome Measures

Primary Outcomes (1)

• M.D. Anderson Dysphagia Inventory (MDADI) swallowing quality of life score

  Baseline and at 1, 3, 6, and 12 months following completion of radiotherapy

Secondary Outcomes (7)

• Penetration Aspiration Scale (PAS) as assessed via FEES

  Baseline and at 1, 3, and 6 months following completion of radiotherapy

• Diet level (Dysphagia Outcome and Severity Scale (DOSS)) as assessed via FEES

  Baseline and at 1, 3, and 6 months following completion of radiotherapy

• Feeding tube duration (days)

  Baseline and at 1, 3, and 6 months following completion of radiotherapy

• Eating Assessment Tool (EAT) quality of life score

  Baseline and at 1, 3, and 6 months following completion of radiotherapy

• Lingual strength as assessed by lingual manometry

  Baseline and at 1, 3, and 6 months following completion of radiotherapy

Study Arms (2)

Arm I (Early exercise group)

EXPERIMENTAL

Patients perform swallowing exercises comprising lingual press, head lift, breath hold, Masako swallow, high pitch e, effortful swallow, and neck stretch and massage for 2 weeks prior to beginning radiotherapy and again immediately after completion of radiotherapy.

Behavioral: exercise intervention; Other: questionnaire administration; Procedure: quality-of-life assessment

Arm II (Late exercise group)

EXPERIMENTAL

Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.

Behavioral: exercise intervention; Other: questionnaire administration; Procedure: quality-of-life assessment

Interventions

exercise intervention BEHAVIORAL

The early exercise group will start study exercises approximately two weeks prior to the onset of XRT. The late exercise group will start study exercises one month after the completion of XRT. Participants will undergo an initial/pre-radiation and 1-, 3-, 6-, and 12 month post-radiation swallowing assessments.

Arm I (Early exercise group); Arm II (Late exercise group)

questionnaire administration OTHER

Ancillary study

Arm I (Early exercise group); Arm II (Late exercise group)

quality-of-life assessment PROCEDURE

Ancillary study

Also known as: quality of life assessment

Arm I (Early exercise group); Arm II (Late exercise group)

Eligibility Criteria

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

You may qualify if:

• Written informed consent must be obtained from all participants prior to beginning therapy (participants should have the ability to understand be willing to sign a written informed consent document)
• Individuals with oropharyngeal, hypopharyngeal, or laryngeal cancer of Stages I-IV undergoing radiation and chemo therapies at Wake Forest Baptist Medical Center
• Participants will have surgically received no more than selective neck dissection and tumor biopsy (participants who have undergone primary tumor resection or radical neck dissection will not be eligible)
• Participants must have completed a minimum of third grade education in order to answer questions of the quality of life survey
• Participants must be willing to participate in the swallowing exercise program

You may not qualify if:

• Medical history of cerebrovascular accident, Parkinson's disease, any type of dementia, myasthenia gravis, or amyotrophic lateral sclerosis
• Previous radiation treatment for head/neck cancer
• Swallowing problem of etiology other than current lesion
• Pregnant women are not anticipated in the patient population, but would be excluded from participation in the study

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Hypopharyngeal Neoplasms; Laryngeal Neoplasms; Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms

Study Officials

• Susan Butler

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2010
• First Posted: January 21, 2010
• Study Start: November 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 1, 2018

Record last verified: 2018-07

Locations

US (1)