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Trial record 1 of 1 for:    NCT03455608
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PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer (PRO-ACTIVE)

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ClinicalTrials.gov Identifier: NCT03455608
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : November 28, 2022
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
Applied Health Research Centre
Qualitative Health Research Consultants, LLC
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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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.


Condition or disease Intervention/treatment Phase
Dysphagia Behavioral: RE-ACTIVE Behavioral: PRO-ACTIVE EAT Behavioral: PRO-ACTIVE EAT + EXERCISE Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 952 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PRO-ACTIVE: Comparing The Effectiveness of Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer
Actual Study Start Date : September 27, 2018
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. The MD Anderson Dysphagia Inventory (MDADI) [ Time Frame: Baseline, Week 6/7, 3 months, 12 months ]
    Measurement of swallowing-related Quality of Life

  2. 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.

  3. 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.

  4. Pharyngeal Constriction Ratio (PCR) [ Time Frame: Baseline, 3 months, 12 months ]
    Videofluoroscopy study score ranging from 0 to 1, where 1 is worst.

  5. Penetration-Aspiration Scale (PAS) [ Time Frame: Baseline, 3 months, 12 months ]
    Videofluoroscopy study score ranging from 1 to 8, where 8 is worst.

  6. Peak esophageal opening [ Time Frame: Baseline, 3 months, 12 months ]
    Videofluoroscopy study score ranging from 0 to infinity, where lower value is worse.

  7. 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

  8. 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

  9. Cancer Behavior Inventory (CBI-V3) [ Time Frame: Baseline, 3 months, 12 months ]
    Measurement of self-efficacy strategies for coping with cancer

  10. EQ-5D-5L [ Time Frame: Baseline, 3 months, 12 months ]
    Measurement of generic quality of life

  11. 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.

  12. 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

  13. Mouth Opening/Trismus [ Time Frame: Baseline; 3 Month and 12 Months ]
    Measurement of interincisal opening

  14. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455608


Contacts
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Contact: Melissa Giamou 416-864-6060 ext 47889 melissa.giamou@unityhealth.to

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33146
Contact: Mario Landera, SLPD, CCC-SLP, BCS-S         
Orlando Health Recruiting
Orlando, Florida, United States, 32806
Contact: Annette May, MA, CCC-SLP, BCS-S         
United States, Maryland
Greater Baltimore Medical Center Active, not recruiting
Baltimore, Maryland, United States, 21204
United States, Massachusetts
Boston University Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02118
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Diana Walker, MA, CCC-SLP         
Principal Investigator: Steven Chang, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10017
Contact: Jennifer Cracchiolo, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Brittany Krekeler, PhD, CCC-SLP         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jamie Ku, MD         
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Kate Hutcheson, PhD         
United States, Wisconsin
University of Wisconsin Hospitals and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Timothy McCulloch, MD         
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada
Contact: Julie Theurer, PhD         
Contact: David Palma, MD         
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Rosemary Martino, PhD         
Canada, Quebec
Jewish General Hospital Recruiting
Montréal, Quebec, Canada, H3T 1E2
Contact: Khalil Sultanem, MD         
Sponsors and Collaborators
University Health Network, Toronto
M.D. Anderson Cancer Center
Applied Health Research Centre
Qualitative Health Research Consultants, LLC
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Rosemary Martino, PhD University Health Network, Toronto
Principal Investigator: Kate Hutcheson, PhD M.D. Anderson Cancer Center
More Information
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Publications:
National Cancer Institute. SEER cancer statistics factsheets: Larynx cancer. http://seer.cancer.gov/statfacts/html/laryn.html. Accessed December 12, 2016.
Canadian Cancer Society's Advisory Committee on Cancer Statistics. Canadian cancer statistics 2016. 2016; http://www.cancer.ca/en/cancer-information/cancer-101/canadian-cancer-statistics-publication/?region=on. Accessed December 12, 2016.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03455608    
Other Study ID Numbers: CTO1363
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: November 28, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
dysphagia
swallowing disorder
speech pathology
swallowing therapy
 head and neck cancer
radiotherapy
toxicity
supportive care
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Deglutition Disorders
Neoplasms by Site
Neoplasms
Esophageal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases