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

Head and Neck Cancer Clinical Trial

Official title:

Effects of Early vs Late Onset of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01053546
• Other study ID #: IRB00010437
• Secondary ID: NCI-2009-01445CC
• Status: Terminated
• Phase: N/A
• Start date: November 2010
• Est. completion date: March 2012

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Hypopharyngeal Neoplasms
• Laryngeal Neoplasms
• Oropharyngeal Neoplasms
• 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

Intervention

Behavioral:
• exercise intervention
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.

Other:
• questionnaire administration
Ancillary study

Procedure:
• quality-of-life assessment
Ancillary study

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Penetration Aspiration Scale (PAS) as assessed via FEES		Baseline and at 1, 3, and 6 months following completion of radiotherapy
Secondary	Diet level (Dysphagia Outcome and Severity Scale (DOSS)) as assessed via FEES		Baseline and at 1, 3, and 6 months following completion of radiotherapy
Secondary	Feeding tube duration (days)		Baseline and at 1, 3, and 6 months following completion of radiotherapy
Secondary	Eating Assessment Tool (EAT) quality of life score		Baseline and at 1, 3, and 6 months following completion of radiotherapy
Secondary	Lingual strength as assessed by lingual manometry		Baseline and at 1, 3, and 6 months following completion of radiotherapy
Secondary	Percent weight loss		Baseline and at 1, 3, and 6 months following completion of radiotherapy
Secondary	Percent weight recovery		Baseline and at 1, 3, and 6 months following completion of radiotherapy