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NCT03455608 · ClinicalTrials.gov registry record · NA
PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer
A NA study of Dysphagia, sponsored by University Health Network, Toronto.
- Completed
- Registry status
- NA
- Development phase
- 952
- Enrollment target
- 13
- Study locations
NCT03455608 is a NA study of Dysphagia that has completed, run by University Health Network, Toronto. The registered enrollment target is 952 participants, above the 145-participant average among 35 other Dysphagia trials with a reported enrollment target (557% higher). The trial reports 13 study locations across 10 states.
The verdict
NCT03455608, a NA study of Dysphagia, has completed, sponsored by University Health Network, Toronto.
- COMPLETED
- Registry status
- NA
- Development phase
- 952 participants
- Enrollment target
- 13
- Study locations
Study 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 risk of pneumonia after RT, which is associated with a 42 percent excess risk of death in survivorship. Moreover, dysphagia predisposes individuals to malnutrition, and at least half of HNC patients require feeding tubes during RT. Patients are commonly referred for swallowing therapy with a speech pathologist. Some patients receive early intervention, before a swallowing problem begins-PRO-ACTIVE therapy. Other patients are monitored and prescribed dysphagia interventions only if and when a swallowing problem occurs-RE-ACTIVE therapy. Thus, REACTIVE therapy aims to reverse an already impaired swallowing ability, whereas PRO-ACTIVE therapy aims to prevent or reduce severity of dysphagia. These two broad categories of therapy represent the most common types of intervention offered to HNC patients across North America. Although there is single-institution evidence to support each practice, it is yet unknown which is most effective. To address this gap, the primary aim of this international, multi-site 3-arm pragmatic randomized clinical trial is to compare the effectiveness of PRO-ACTIVE (high and low intensity) versus RE-ACTIVE swallowing therapy among 952 patients with HNC planning to undergo RT, using duration of feeding tube dependence after RT as the primary outcome. Our secondary aim proposes to compare the relative benefit or harm of these swallowing interventions on secondary outcomes considered relevant to our stakeholder partners.
Conditions Studied
Interventions
- BEHAVIORAL RE-ACTIVE
- BEHAVIORAL PRO-ACTIVE EAT
- BEHAVIORAL PRO-ACTIVE EAT + EXERCISE
Study Locations (13)
Florida
- University of Miami - Miami
- Orlando Health - Orlando
Ohio
- University of Cincinnati - Cincinnati
- Cleveland Clinic - Cleveland
Ontario
- London Health Sciences Centre - London
- University Health Network - Toronto
Maryland
- Greater Baltimore Medical Center - Baltimore
Massachusetts
- Boston University Medical Center - Boston
Michigan
- Henry Ford Health System - Detroit
New York
- Memorial Sloan Kettering Cancer Center - New York
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 952 participants |
| Start Date | 2018-09-27 |
| Est. Completion | 2024-11-15 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03455608
The ClinicalTrials.gov registry entry for NCT03455608 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 952 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 145-participant average among 35 other Dysphagia trials with a reported enrollment target (557% higher). The listed sponsor is University Health Network, Toronto, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Dysphagia appearing as the primary indexed condition, and to 3 interventions - of which RE-ACTIVE is the first listed.
NCT03455608 reports 13 study locations spanning 10 distinct geographic areas - top geographies include Florida, Ohio, Ontario.
Frequently Asked Questions
What is clinical trial NCT03455608 about?
NCT03455608 is a clinical study titled "PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer". 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 risk of pneumonia after RT, which is associated with a 42 percent excess risk of death in survivorshi...
What is the current status of trial NCT03455608?
This trial is currently completed. It is a NA study. The enrollment target is 952 participants. The study started on 2018-09-27. Estimated completion is 2024-11-15.
What conditions does trial NCT03455608 study?
This clinical trial studies the following conditions: Dysphagia.
What interventions are being tested in trial NCT03455608?
The interventions under investigation include: RE-ACTIVE (BEHAVIORAL), PRO-ACTIVE EAT (BEHAVIORAL), PRO-ACTIVE EAT + EXERCISE (BEHAVIORAL).
Who is sponsoring clinical trial NCT03455608?
This trial is sponsored by University Health Network, Toronto, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03455608 being conducted?
This trial has 13 study locations across Florida, Maryland, Massachusetts, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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