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

NCT03455608 | Completed DMC

• 1 other identifier: CTO1363
• Study Type: interventional
• Target: 952
• Locations: 2 countries
• Sites: 13

Brief 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.

Conditions

Dysphagia

Keywords

dysphagia; swallowing disorder; speech pathology; swallowing therapy; head and neck cancer; radiotherapy; toxicity; supportive care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• The MD Anderson Dysphagia Inventory (MDADI)

  Baseline, Week 6/7, 3 months, 12 months

• The MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)

  Baseline, Week 2, Week 4, Week 6/7, 3 months, 12 months

• Dynamic Imaging Grade of Swallowing Toxicity (DIGEST)

  Baseline, 3 months, 12 months

• Pharyngeal Constriction Ratio (PCR)

  Baseline, 3 months, 12 months

• Penetration-Aspiration Scale (PAS)

  Baseline, 3 months, 12 months

Study Arms (3)

RE-ACTIVE

ACTIVE COMPARATOR

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

Behavioral: RE-ACTIVE

PRO-ACTIVE EAT

ACTIVE COMPARATOR

Early low intensity proactive intervention started before RT commences

Behavioral: PRO-ACTIVE EAT

PRO-ACTIVE EAT + EXERCISE

ACTIVE COMPARATOR

Early high intensity proactive intervention started before RT commences

Behavioral: PRO-ACTIVE EAT + EXERCISE

Interventions

RE-ACTIVE BEHAVIORAL

Reactive intervention started promptly if/when dysphagia is identified

RE-ACTIVE

PRO-ACTIVE EAT BEHAVIORAL

Early low intensity proactive intervention started before RT commences

PRO-ACTIVE EAT

PRO-ACTIVE EAT + EXERCISE BEHAVIORAL

Early high intensity proactive intervention started before RT commences

PRO-ACTIVE EAT + EXERCISE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• M.D. Anderson Cancer Center: collaborator
• Applied Health Research Centre: collaborator
• Qualitative Health Research Consultants, LLC: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (13)

University of Miami

Miami, Florida, 33146, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10017, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Wisconsin Hospitals and Clinics

Madison, Wisconsin, 53792, United States

Location

London Health Sciences Centre

London, Ontario, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (31)

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  PMID: 34645411 DERIVED

MeSH Terms

Conditions

Deglutition Disorders; Head and Neck Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rosemary Martino, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Kate Hutcheson, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2018
• First Posted: March 6, 2018
• Study Start: September 27, 2018
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (10); CA (3)