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PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer
NCT03455608 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 952 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Health Network, Toronto, which has 67 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03455608 reports 13 study locations spanning 10 distinct geographic areas — top geographies include Florida, Ohio, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03455608?
This trial is sponsored by University Health Network, Toronto, which has 67 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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