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

October 9, 2023 updated by: University Health Network, Toronto

PRO-ACTIVE: Comparing The Effectiveness of 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

952

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada
        • London Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network
    • Quebec
      • Montréal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
  • United States
    • Florida
      • Miami, Florida, United States, 33146
        • University of Miami
      • Orlando, Florida, United States, 32806
        • Orlando Health
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • New York
      • New York, New York, United States, 10017
        • Memorial Sloan Kettering Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RE-ACTIVE
Reactive intervention started promptly if/when dysphagia is identified (RE-ACTIVE)
Behavioral: RE-ACTIVE
Reactive intervention started promptly if/when dysphagia is identified
Active Comparator: PRO-ACTIVE EAT
Early low intensity proactive intervention started before RT commences
Behavioral: PRO-ACTIVE EAT
Early low intensity proactive intervention started before RT commences
Active Comparator: PRO-ACTIVE EAT + EXERCISE
Early high intensity proactive intervention started before RT commences
Behavioral: PRO-ACTIVE EAT + EXERCISE
Early high intensity proactive intervention started before RT commences

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of feeding tube dependence
Time Frame: Baseline - 12 months
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Patient-Centered Outcomes Research Institute
M.D. Anderson Cancer Center
Applied Health Research Centre
Qualitative Health Research Consultants, LLC

Investigators

  • Principal Investigator: Rosemary Martino, PhD, University Health Network, Toronto
  • Principal Investigator: Kate Hutcheson, PhD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2018

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 11, 2018

First Submitted That Met QC Criteria

February 27, 2018

First Posted (Actual)

March 6, 2018

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTO1363

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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