Prophylactic Swallow Intervention for Head and Neck Cancer

(PRO-ACTIVE Trial)

Recruiting at12 trial locations

Overseen by Rosemary Martino, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kate Hutcheson, PhD

Principal Investigator

M.D. Anderson Cancer Center

Rosemary Martino, PhD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for adults over 18 with head and neck cancer who are set to undergo radiotherapy aimed at curing the disease. They must understand English, French, Spanish or Simplified Chinese well enough to fill out questionnaires. People can't join if they already have moderate/severe swallowing issues, previous swallowing therapy for their current cancer, other thorax or CNS cancers, distant metastasis, or planned total laryngectomy.

Inclusion Criteria

My radiation therapy is aimed at curing my condition.

I can fluently read and write in English, French, Spanish, or Simplified Chinese.

I am set to receive a high-dose radiation treatment at a participating center.

Exclusion Criteria

I have had or will have my voice box removed.

I have moderate to severe difficulty swallowing.

I have been diagnosed with a second primary cancer in my chest or brain.

Treatment Details

Interventions

• PRO-ACTIVE EAT (Behavioral Intervention)
• PRO-ACTIVE EAT + EXERCISE (Behavioral Intervention)
• RE-ACTIVE (Behavioral Intervention)

Trial Overview The study compares two types of swallow therapies in patients receiving radiotherapy: PRO-ACTIVE (early intervention) and RE-ACTIVE (intervention after problems occur). It's a large international trial with three groups—high intensity PRO-ACTIVE EAT + EXERCISE, low intensity PRO-ACTIVE EAT only and REACTIVE—to see which method best reduces feeding tube dependence post-treatment.

Participant Groups

Group I: PRO-ACTIVE EAT + EXERCISE Active Control 1 Intervention

Early high intensity proactive intervention started before RT commences

Group II: RE-ACTIVE Active Control 1 Intervention

Reactive intervention started promptly if/when dysphagia is identified (RE-ACTIVE)

Group III: PRO-ACTIVE EAT Active Control 1 Intervention

Early low intensity proactive intervention started before RT commences

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Dr. Brad Wouters

University Health Network, Toronto

Chief Medical Officer since 2020

MD from University of Toronto

Dr. Kevin Smith

University Health Network, Toronto

Chief Executive Officer since 2018

Professor at McMaster University and University of Toronto

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

Applied Health Research Centre

Collaborator

Trials

23

Recruited

70,900+

Qualitative Health Research Consultants, LLC

Collaborator

Trials

1

Recruited

950+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Nakela L. Cook

Patient-Centered Outcomes Research Institute

Chief Executive Officer since 2020

MD, MPH

Harv Feldman

Patient-Centered Outcomes Research Institute

Chief Medical Officer

MD, MSCE