Neoplasms

All Conditions

Digestive System Diseases

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Head and Neck Neoplasms

Deglutition Disorders

Esophageal Diseases

Gastrointestinal Diseases

Pharyngeal Diseases

Otorhinolaryngologic Diseases

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

Early low intensity proactive intervention started before RT commences

Early high intensity proactive intervention started before RT commences

Reactive intervention started promptly if/when dysphagia is identified

RE-ACTIVE

PRO-ACTIVE EAT

PRO-ACTIVE EAT + EXERCISE

Rosemary Martino, PhD

Kate Hutcheson, PhD

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.

Swallowing therapy is commonly provided as a behavioral treatment to lessen the risk or severity of dysphagia in head and neck cancer (HNC) patients; however, best practice is not established. This multi-site, international randomized clinical trial (RCT) will compare the effectiveness of PRO-ACTIVE (high and low intensity) versus RE-ACTIVE swallowing interventions in 952 HNC patients undergoing radiotherapy (RT). The 3 study arms represent alternate timing and intensity of swallowing therapy delivered by a speech language pathologist: 1) RE-ACTIVE, 2) PRO-ACTIVE EAT, and 3) PRO-ACTIVE EAT + EXERCISE.

The primary aim of the PRO-ACTIVE trial is to compare the effectiveness of PRO-ACTIVE versus RE-ACTIVE swallowing interventions among patients with HNC planned to undergo RT. We hypothesize that the combined PRO-ACTIVE therapies are more effective than RE-ACTIVE therapy; and, if so, that more intensive PRO-ACTIVE (EAT + EXERCISE) is superior to less intensive PRO-ACTIVE (EAT). Effectiveness will be measured based on reduced duration of feeding tube dependency as the primary endpoint, an outcome valued equally by patients, caregivers and clinicians.

The secondary aim of the PRO-ACTIVE trial is to compare the relative benefit or harm of swallowing therapy arms on secondary outcomes including videofluoroscopic swallowing evaluations, functional status measures, health status measures, and patient-reported outcomes.

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

PRO-ACTIVE: Comparing The Effectiveness of Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer

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)

Measurement of swallowing-related Quality of Life

Measurement of severity or burden of cancer-related symptoms and interference with daily functioning.

Videofluoroscopy study score ranging from 0 to 5, where 4 is worst.

Videofluoroscopy study score ranging from 0 to 1, where 1 is worst.

Videofluoroscopy study score ranging from 1 to 8, where 8 is worst.

Videofluoroscopy study score ranging from 0 to infinity, where lower value is worse.

Measurement of swallowing and speech performance

Patient reported symptoms related to health consequences secondary to dysphagia, namely: malnutrition, aspiration pneumonia and mood changes such as depression and anxiety

Measurement of self-efficacy strategies for coping with cancer

Intake details, radiation therapy details, chemotherapy details, tumour status, surgery history, tracheotomy, feeding tube status, feeding tube dependence, concomitant therapies, and complication details.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer	NCT03455608	Dysphagia	RE-ACTIVE PRO-ACTIVE EAT PRO-ACTIVE EAT ...	18 Years -	University Health Network, Toronto
PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer	NCT03455608	Dysphagia	RE-ACTIVE PRO-ACTIVE EAT PRO-ACTIVE EAT ...	18 Years -	University Health Network, Toronto

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