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



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:September 27, 2018
End Date:August 2022
Contact:Daniel Jin
Email:jind@smh.ca
Phone:416-864-6060

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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.

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.

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 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
We found this trial at
5
sites
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Madison, WI
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1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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Boston, MA
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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London,
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New York, New York 10003
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New York, NY
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