PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer
NCT ID: NCT03455608
Last Updated: 2024-12-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
952 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-09-27
Study Completion Date
2024-11-15
Brief Summary
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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.
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.
Detailed Description
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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.
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.
Conditions
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Dysphagia
Keywords
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dysphagia
swallowing disorder
speech pathology
swallowing therapy
head and neck cancer
radiotherapy
toxicity
supportive care
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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RE-ACTIVE
Reactive intervention started promptly if/when dysphagia is identified (RE-ACTIVE)
Group Type
ACTIVE_COMPARATOR
RE-ACTIVE
Intervention Type
BEHAVIORAL
Reactive intervention started promptly if/when dysphagia is identified
PRO-ACTIVE EAT
Early low intensity proactive intervention started before RT commences
Group Type
ACTIVE_COMPARATOR
PRO-ACTIVE EAT
Intervention Type
BEHAVIORAL
Early low intensity proactive intervention started before RT commences
PRO-ACTIVE EAT + EXERCISE
Early high intensity proactive intervention started before RT commences
Group Type
ACTIVE_COMPARATOR
PRO-ACTIVE EAT + EXERCISE
Intervention Type
BEHAVIORAL
Early high intensity proactive intervention started before RT commences
Interventions
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RE-ACTIVE
Reactive intervention started promptly if/when dysphagia is identified
Intervention Type
BEHAVIORAL
PRO-ACTIVE EAT
Early low intensity proactive intervention started before RT commences
Intervention Type
BEHAVIORAL
PRO-ACTIVE EAT + EXERCISE
Early high intensity proactive intervention started before RT commences
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Sponsor Role
collaborator
Applied Health Research Centre
OTHER
Sponsor Role
collaborator
Qualitative Health Research Consultants, LLC
UNKNOWN
Sponsor Role
collaborator
Patient-Centered Outcomes Research Institute
OTHER
Sponsor Role
collaborator
University Health Network, Toronto
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Rosemary Martino, PhD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Kate Hutcheson, PhD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Miami
Miami, Florida, United States
Site Status
Orlando Health
Orlando, Florida, United States
Site Status
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Site Status
Boston University Medical Center
Boston, Massachusetts, United States
Site Status
Henry Ford Health System
Detroit, Michigan, United States
Site Status
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Site Status
University of Cincinnati
Cincinnati, Ohio, United States
Site Status
Cleveland Clinic
Cleveland, Ohio, United States
Site Status
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Site Status
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, United States
Site Status
London Health Sciences Centre
London, Ontario, Canada
Site Status
University Health Network
Toronto, Ontario, Canada
Site Status
Jewish General Hospital
Montreal, Quebec, Canada
Site Status
Countries
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United States
Canada
References
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Reference Type
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Xu B, Boero IJ, Hwang L, Le QT, Moiseenko V, Sanghvi PR, Cohen EE, Mell LK, Murphy JD. Aspiration pneumonia after concurrent chemoradiotherapy for head and neck cancer. Cancer. 2015 Apr 15;121(8):1303-11. doi: 10.1002/cncr.29207. Epub 2014 Dec 23.
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BACKGROUND
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BACKGROUND
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Martino R, Fitch MI, Fuller CD, Hope A, Krisciunas G, Langmore SE, Lazarus C, Macdonald CL, McCulloch T, Mills G, Palma DA, Pytynia K, Ringash J, Sultanem K, Theurer J, Thorpe KE, Hutcheson K. The PRO-ACTIVE trial protocol: a randomized study comparing the effectiveness of PROphylACTic swallow InterVEntion for patients receiving radiotherapy for head and neck cancer. BMC Cancer. 2021 Oct 13;21(1):1100. doi: 10.1186/s12885-021-08826-0.
Reference Type
DERIVED
Other Identifiers
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CTO1363
Identifier Type: -
Identifier Source: org_study_id