Clinical trial NCT01053546: Effects of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer
Official title: Effects of Early vs Late Onset of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2010-01-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: PRIMARY OBJECTIVE:

I. To assess the difference between early and late onset swallowing exercises on swallowing quality of life in patients undergoing chemo/radiation therapy for head and neck cancer.

SECONDARY OBJECTIVE:

I. To assess the difference between early and late onset swallowing exercises on swallowing function in patients undergoing radiation therapy for head and neck cancer.

TERTIARY OBJECTIVE:

I. To assess the difference between early and late onset swallowing exercises on: individual domains of swallowing quality of life; Penetration Aspiration Scale (PAS) as assessed via FEES; diet level (Dysphagia Outcome and Severity Scale (DOSS) as assessed via FEES; feeding tube duration (days); Eating Assessment Tool (EAT); lingual strength as assessed via lingual manometry; and percent weight loss and percent weight recovery.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I (Early exercise group): 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.

Arm II (Late exercise group): Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.

In both arms, swallowing exercises are performed twice daily, 6 days a week, for 12 months following completion of radiotherapy.

Eligibility criteria: Inclusion

* 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

Exclusion

* 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

Primary outcomes:
measure: M.D. Anderson Dysphagia Inventory (MDADI) swallowing quality of life score
timeFrame: Baseline and at 1, 3, 6, and 12 months following completion of radiotherapy
Secondary outcomes:
measure: Penetration Aspiration Scale (PAS) as assessed via FEES
timeFrame: Baseline and at 1, 3, and 6 months following completion of radiotherapy
measure: Diet level (Dysphagia Outcome and Severity Scale (DOSS)) as assessed via FEES
timeFrame: Baseline and at 1, 3, and 6 months following completion of radiotherapy
measure: Feeding tube duration (days)
timeFrame: Baseline and at 1, 3, and 6 months following completion of radiotherapy
measure: Eating Assessment Tool (EAT) quality of life score
timeFrame: Baseline and at 1, 3, and 6 months following completion of radiotherapy
measure: Lingual strength as assessed by lingual manometry
timeFrame: Baseline and at 1, 3, and 6 months following completion of radiotherapy
measure: Percent weight loss
timeFrame: Baseline and at 1, 3, and 6 months following completion of radiotherapy
measure: Percent weight recovery
timeFrame: Baseline and at 1, 3, and 6 months following completion of radiotherapy
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Susan Butler
role: PRINCIPAL_INVESTIGATOR
References: