Clinical trial · Interventional
Effects of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer
Effects of Early vs Late Onset of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
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
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Stage I Hypopharyngeal Cancer | Malignant Hypopharyngeal Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Hypopharyngeal Cancer | Malignant Hypopharyngeal Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Hypopharyngeal Cancer | Malignant Hypopharyngeal Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Laryngeal Cancer | Malignant Laryngeal Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Laryngeal Cancer | Malignant Laryngeal Neoplasm |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exercise intervention | Behavioral | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (Early exercise group)
- description
- 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.
- interventionNames
- Behavioral: exercise intervention
- Other: questionnaire administration
- Procedure: quality-of-life assessment
- type
- EXPERIMENTAL
- label
- Arm II (Late exercise group)
- description
- Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.
- interventionNames
- Behavioral: exercise intervention
- Other: questionnaire administration
- Procedure: quality-of-life assessment
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available