PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer

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

• Dysphagia

Interventions

BEHAVIORAL

RE-ACTIVE

Reactive intervention started promptly if/when dysphagia is identified

BEHAVIORAL

PRO-ACTIVE EAT

Early low intensity proactive intervention started before RT commences

BEHAVIORAL

PRO-ACTIVE EAT + EXERCISE

Early high intensity proactive intervention started before RT commences

Sponsors & Collaborators

• M.D. Anderson Cancer Center

  collaborator OTHER

• Applied Health Research Centre

  collaborator OTHER

• Qualitative Health Research Consultants, LLC

  collaborator UNKNOWN

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University Health Network, Toronto

  lead OTHER

Principal Investigators

• Rosemary Martino, PhD · University Health Network, Toronto

• Kate Hutcheson, PhD · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-27

Primary Completion

2024-11-15

Completion

2024-11-15

Countries

• United States
• Canada

Study Locations