Status:
COMPLETED
PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
M.D. Anderson Cancer Center
Applied Health Research Centre
Conditions:
Dysphagia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Dysphagia (difficulty swallowing) is a common and potentially life-threatening toxicity of radiotherapy (RT) for patients with head and neck cancer (HNC). HNC survivors have a 20-24 percent lifetime r...
Detailed Description
Swallowing therapy is commonly provided as a behavioral treatment to lessen the risk or severity of dysphagia in head and neck cancer (HNC) patients; however, best practice is not established. This mu...
Eligibility Criteria
Inclusion
- Adults ≥ 18 years of age diagnosed with head and neck malignancy;
- RT treatment planned for curative intent;
- Dispositioned to receive external beam radiotherapy dose ≥60 gray to bilateral fields at participating institution;
- Sufficient fluency in written English, French, Spanish or Simplified Chinese to be able to complete the study patient reported outcome questionnaires
Exclusion
- Distant metastasis at enrollment; or
- Prior or planned total laryngectomy; or
- Moderate/severe dysphagia at enrollment per baseline videofluoroscopy DIGEST grade ≥2 (as graded per central laboratory review)
- Previously seen by speech language pathologist for swallowing therapy for the current head and neck cancer
- Diagnosis of second primary non-head and neck cancers in the thorax or the central nervous system at enrollment
- Head and neck radiotherapy for thyroid or cutaneous/skin primary tumors, regardless of neck fields
Key Trial Info
Start Date :
September 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2024
Estimated Enrollment :
952 Patients enrolled
Trial Details
Trial ID
NCT03455608
Start Date
September 27 2018
End Date
November 15 2024
Last Update
December 10 2024
Active Locations (13)
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1
University of Miami
Miami, Florida, United States, 33146
2
Orlando Health
Orlando, Florida, United States, 32806
3
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
4
Boston University Medical Center
Boston, Massachusetts, United States, 02118