An interventional study of RE-ACTIVE and PRO-ACTIVE EAT in Dysphagia, sponsored by University Health Network, Toronto. Completed at 13 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Reactive intervention started promptly if/when dysphagia is identified (RE-ACTIVE)
Behavioral: RE-ACTIVE
Early low intensity proactive intervention started before RT commences
Behavioral: PRO-ACTIVE EAT
Early high intensity proactive intervention started before RT commences
Behavioral: PRO-ACTIVE EAT + EXERCISE
Reactive intervention started promptly if/when dysphagia is identified
Early low intensity proactive intervention started before RT commences
Early high intensity proactive intervention started before RT commences
Duration of feeding tube dependence
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)
Time frame: Baseline - 12 months
The MD Anderson Dysphagia Inventory (MDADI)
Measurement of swallowing-related Quality of Life
Time frame: Baseline, Week 6/7, 3 months, 12 months
The MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
Measurement of severity or burden of cancer-related symptoms and interference with daily functioning.
Time frame: Baseline, Week 2, Week 4, Week 6/7, 3 months, 12 months
Dynamic Imaging Grade of Swallowing Toxicity (DIGEST)
Videofluoroscopy study score ranging from 0 to 5, where 4 is worst.
Time frame: Baseline, 3 months, 12 months
Pharyngeal Constriction Ratio (PCR)
Videofluoroscopy study score ranging from 0 to 1, where 1 is worst.
Time frame: Baseline, 3 months, 12 months
Penetration-Aspiration Scale (PAS)
Videofluoroscopy study score ranging from 1 to 8, where 8 is worst.
Time frame: Baseline, 3 months, 12 months
Peak esophageal opening
Videofluoroscopy study score ranging from 0 to infinity, where lower value is worse.
Time frame: Baseline, 3 months, 12 months
Performance Status Scale Head and Neck (PSS-HN)
Measurement of swallowing and speech performance
Time frame: Baseline, Week 2, Week 4, Week 6/7, 3 months, 12 months
Medical Outcome of Dysphagia (MOD)
Patient reported symptoms related to health consequences secondary to dysphagia, namely: malnutrition, aspiration pneumonia and mood changes such as depression and anxiety
Time frame: Baseline, 3 months, 12 months
Cancer Behavior Inventory (CBI-V3)
Measurement of self-efficacy strategies for coping with cancer
Time frame: Baseline, 3 months, 12 months
EQ-5D-5L
Measurement of generic quality of life
Time frame: Baseline, 3 months, 12 months
Medical History
Intake details, radiation therapy details, chemotherapy details, tumour status, surgery history, tracheotomy, feeding tube status, feeding tube dependence, concomitant therapies, and complication details.
Time frame: Baseline, Week 6/7, 3 months, 12 months
Pain Medications
All pain medications (including over-the-counter) taken in the past 48 hours
Time frame: Baseline; Week 6/7, 3 Month, and 12 Months
Mouth Opening/Trismus
Measurement of interincisal opening
Time frame: Baseline; 3 Month and 12 Months
Hospitalization/Emergency Department (ED) Presentation
Hospitalization/ED presentation at cancer hospital or any external institutions
Time frame: Baseline, Week 6/7, 3 months, 12 months
Plan to share: No
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University Health Network, Toronto