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Prophylactic Swallow Intervention for Head and Neck Cancer (PRO-ACTIVE Trial)

N/A
Waitlist Available
Led By Rosemary Martino, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
RT treatment planned for curative intent
Sufficient fluency in written English, French, Spanish or Simplified Chinese to be able to complete the study patient reported outcome questionnaires
Must not have
Prior or planned total laryngectomy
Moderate/severe dysphagia at enrollment per baseline videofluoroscopy DIGEST grade ≥2 (as graded per central laboratory review)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline - 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will 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.

Who is the study for?
This trial is for adults over 18 with head and neck cancer who are set to undergo radiotherapy aimed at curing the disease. They must understand English, French, Spanish or Simplified Chinese well enough to fill out questionnaires. People can't join if they already have moderate/severe swallowing issues, previous swallowing therapy for their current cancer, other thorax or CNS cancers, distant metastasis, or planned total laryngectomy.
What is being tested?
The study compares two types of swallow therapies in patients receiving radiotherapy: PRO-ACTIVE (early intervention) and RE-ACTIVE (intervention after problems occur). It's a large international trial with three groups—high intensity PRO-ACTIVE EAT + EXERCISE, low intensity PRO-ACTIVE EAT only and REACTIVE—to see which method best reduces feeding tube dependence post-treatment.
What are the potential side effects?
While specific side effects aren't listed for the interventions since they involve eating strategies and exercises rather than drugs, general risks may include discomfort from exercising muscles used to swallow and potential frustration or stress from adhering to therapy regimens.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My radiation therapy is aimed at curing my condition.
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I can fluently read and write in English, French, Spanish, or Simplified Chinese.
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I am set to receive a high-dose radiation treatment at a participating center.
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I am 18 or older with a head or neck cancer diagnosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had or will have my voice box removed.
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I have moderate to severe difficulty swallowing.
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I have been diagnosed with a second primary cancer in my chest or brain.
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My cancer has spread to distant parts of my body.
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I have seen a speech therapist for swallowing issues due to my head and neck cancer.
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I have received radiotherapy for thyroid or skin cancer in the head or neck area.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline - 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline - 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Duration of feeding tube dependence
Secondary study objectives
Cancer Behavior Inventory (CBI-V3)
Dynamic Imaging Grade of Swallowing Toxicity (DIGEST)
EQ-5D-5L
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: PRO-ACTIVE EAT + EXERCISEActive Control1 Intervention
Early high intensity proactive intervention started before RT commences
Group II: RE-ACTIVEActive Control1 Intervention
Reactive intervention started promptly if/when dysphagia is identified (RE-ACTIVE)
Group III: PRO-ACTIVE EATActive Control1 Intervention
Early low intensity proactive intervention started before RT commences

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,523 Previous Clinical Trials
502,246 Total Patients Enrolled
M.D. Anderson Cancer CenterOTHER
3,067 Previous Clinical Trials
1,801,657 Total Patients Enrolled
Applied Health Research CentreOTHER
22 Previous Clinical Trials
69,944 Total Patients Enrolled
~0 spots leftby Dec 2024
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