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

Dysphagia Clinical Trial

— PRO-ACTIVE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03455608
• Other study ID #: CTO1363
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 27, 2018
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 952
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults = 18 years of age diagnosed with head and neck malignancy;
• RT treatment planned for curative intent;
• Dispositioned to receive external beam radiotherapy dose =60 gray to bilateral fields at participating institution;
• Sufficient fluency in written English, French, Spanish or Simplified Chinese to be able to complete the study patient reported outcome questionnaires

Exclusion Criteria:

• Distant metastasis at enrollment; or
• Prior or planned total laryngectomy; or
• Moderate/severe dysphagia at enrollment per baseline videofluoroscopy DIGEST grade =2 (as graded per central laboratory review)
• Previously seen by speech language pathologist for swallowing therapy for the current head and neck cancer
• Diagnosis of second primary non-head and neck cancers in the thorax or the central nervous system at enrollment
• Head and neck radiotherapy for thyroid or cutaneous/skin primary tumors, regardless of neck fields

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Head and Neck Neoplasms

Intervention

Behavioral:
• RE-ACTIVE
Reactive intervention started promptly if/when dysphagia is identified
• PRO-ACTIVE EAT
Early low intensity proactive intervention started before RT commences
• PRO-ACTIVE EAT + EXERCISE
Early high intensity proactive intervention started before RT commences

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	Jewish General Hospital	Montréal	Quebec
Canada	University Health Network	Toronto	Ontario
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	Boston University Medical Center	Boston	Massachusetts
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	University of Wisconsin Hospitals and Clinics	Madison	Wisconsin
United States	University of Miami	Miami	Florida
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Orlando Health	Orlando	Florida

Sponsors (5)

Lead Sponsor	Collaborator
University Health Network, Toronto	Applied Health Research Centre, M.D. Anderson Cancer Center, Patient-Centered Outcomes Research Institute, Qualitative Health Research Consultants, LLC

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline - 12 months
Secondary	The MD Anderson Dysphagia Inventory (MDADI)	Measurement of swallowing-related Quality of Life	Baseline, Week 6/7, 3 months, 12 months
Secondary	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.	Baseline, Week 2, Week 4, Week 6/7, 3 months, 12 months
Secondary	Dynamic Imaging Grade of Swallowing Toxicity (DIGEST)	Videofluoroscopy study score ranging from 0 to 5, where 4 is worst.	Baseline, 3 months, 12 months
Secondary	Pharyngeal Constriction Ratio (PCR)	Videofluoroscopy study score ranging from 0 to 1, where 1 is worst.	Baseline, 3 months, 12 months
Secondary	Penetration-Aspiration Scale (PAS)	Videofluoroscopy study score ranging from 1 to 8, where 8 is worst.	Baseline, 3 months, 12 months
Secondary	Peak esophageal opening	Videofluoroscopy study score ranging from 0 to infinity, where lower value is worse.	Baseline, 3 months, 12 months
Secondary	Performance Status Scale Head and Neck (PSS-HN)	Measurement of swallowing and speech performance	Baseline, Week 2, Week 4, Week 6/7, 3 months, 12 months
Secondary	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	Baseline, 3 months, 12 months
Secondary	Cancer Behavior Inventory (CBI-V3)	Measurement of self-efficacy strategies for coping with cancer	Baseline, 3 months, 12 months
Secondary	EQ-5D-5L	Measurement of generic quality of life	Baseline, 3 months, 12 months
Secondary	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.	Baseline, Week 6/7, 3 months, 12 months
Secondary	Pain Medications	All pain medications (including over-the-counter) taken in the past 48 hours	Baseline; Week 6/7, 3 Month, and 12 Months
Secondary	Mouth Opening/Trismus	Measurement of interincisal opening	Baseline; 3 Month and 12 Months
Secondary	Hospitalization/Emergency Department (ED) Presentation	Hospitalization/ED presentation at cancer hospital or any external institutions	Baseline, Week 6/7, 3 months, 12 months