Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study of Dysphagia, sponsored by University Health Network, Toronto.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Effectiveness will be measured based on duration of feeding tube dependency (count of days from end of radiotherapy to last feeding tube use within the 12-month study period)
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 |
What the finished NCT03455608 record still lists
NCT03455608 is an interventional study that assigns participants to a tested intervention. The registered 952 participants enrollment target is mid-sized for trials with a published cap, above the 145-participant average among 35 other Dysphagia trials with a reported enrollment target (557% higher).
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 lists 13 locations in 10 states (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.
Learn More About Clinical Trials
Similar trials for Dysphagia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03455608's enrollment target sits among peer trials
952 1st of 35 higher than 35 of 35 other Dysphagia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dysphagia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Dissemination and Implementation of DIGEST™ as an Evidence-based Measurement Tool for Dysphagia: A Randomized Implementation Trial
RECRUITING · NA
-
Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia
RECRUITING · NA
-
Velopharyngeal Dysfunction in Head & Neck Cancer Patients, Pilot Study
RECRUITING · NA
-
Evolution of the Chicago Classification: Bridging Physiology and Mechanics
RECRUITING · NA
-
External Pharyngeal Exerciser and Pharyngeal Phase of Swallowing
RECRUITING · NA
-
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04375033 · 952 participants · Phase 4
A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder
- NCT03784924 · 950 participants
EDRN Prostate MRI Biomarker Study
- NCT04180930 · 950 participants
An Evaluation of Two PTSD Assessments in an Active Duty and Military Veteran Sample
- NCT04895709 · 949 participants · Phase 1
A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI