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 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.