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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline - 12 months

Awards & highlights

PRO-ACTIVE Trial 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.Check my eligibility

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.See study design

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.

PRO-ACTIVE Trial 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.

PRO-ACTIVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline - 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Duration of feeding tube dependence

Secondary outcome measures

Cancer Behavior Inventory (CBI-V3)

Dynamic Imaging Grade of Swallowing Toxicity (DIGEST)

EQ-5D-5L

+11 more

PRO-ACTIVE 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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,472 Previous Clinical Trials

484,041 Total Patients Enrolled

M.D. Anderson Cancer CenterOTHER

2,972 Previous Clinical Trials

1,786,347 Total Patients Enrolled

Applied Health Research CentreOTHER

22 Previous Clinical Trials

70,084 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for participants to join this research endeavor?

"Accurate. According to the research hosted on clinicaltrials.gov, this experiment is currently enrolling participants and was initially posted in September of 2018 with a subsequent update being made in November 2022. 952 patients need to be recruited from 11 different sites for full completion of the study protocol."

Answered by AI

How many people are participating in the trial overall?

"This medical trial requires 952 individuals that meet the specified inclusion criteria. Patients can partake in this study from sites such as Memorial Sloan Kettering Cancer Center (New york, NY) and Jewish General Hospital (Montréal, QC)."

Answered by AI

How many centers are engaged in the implementation of this clinical trial?

"Currently, there are 11 clinics running this trial. These locations span from New york to Montréal and Detroit with other sites in between. To make enrollment more accessible, it is beneficial to select the closest clinic for your participation."

Answered by AI

Recent research and studies

DysphagiaJournal

The Effect of Prophylactic Percutaneous Endoscopic Gastrostomy (PEG) Tube Placement on Swallowing and Swallow-related Outcomes in Patients Undergoing Radiotherapy for Head and Neck Cancer: A Systematic Review

Shaw, Stephanie M., Heather Flowers, Brian O’Sullivan, Andrew Hope, Louis W. C. Liu, and Rosemary Martino. 2015. “The Effect of Prophylactic Percutaneous Endoscopic Gastrostomy (PEG) Tube Placement on Swallowing and Swallow-related Outcomes in Patients Undergoing Radiotherapy for Head and Neck Cancer: A Systematic Review”. Dysphagia. Springer Science and Business Media LLC. doi:10.1007/s00455-014-9592-z.

DysphagiaJournal

Survey of Usual Practice: Dysphagia Therapy in Head and Neck Cancer Patients

Krisciunas, Gintas P., William Sokoloff, Katherine Stepas, and Susan E. Langmore. 2012. “Survey of Usual Practice: Dysphagia Therapy in Head and Neck Cancer Patients”. Dysphagia. Springer Science and Business Media LLC. doi:10.1007/s00455-012-9404-2.

CancerJournal

Aspiration Pneumonia After Concurrent Chemoradiotherapy for Head and Neck Cancer

Xu, Beibei, Isabel J. Boero, Lindsay Hwang, Quynh-Thu Le, Vitali Moiseenko, Parag R. Sanghvi, Ezra E. W. Cohen, Loren K. Mell, and James D. Murphy. 2014. “Aspiration Pneumonia After Concurrent Chemoradiotherapy for Head and Neck Cancer”. Cancer. Wiley. doi:10.1002/cncr.29207.

Head & NeckJournal