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Prehabilitation for Head and Neck Cancer Surgery

N/A

Recruiting

Led By Nicole Culos-Reed, PhD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically verified primary head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, or in lymph nodes of the neck from an unknown primary tumour

Scheduled to undergo oncologic resection or resection for benign disease with free flap reconstruction

Must not have

Severe coronary artery disease (Canadian Cardiovascular Society class III or greater)

Significant congestive heart failure (New York Heart Association class III or greater)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to prepare people for surgery who have head and neck cancer.

Who is the study for?

This trial is for adults over 18 who can understand English and are scheduled for surgery with free flap reconstruction due to head and neck cancer or benign disease. They must be cleared by a clinical exercise physiologist or clinician, and have confirmed squamous cell carcinoma in specific areas of the head or neck, or related lymph nodes. People with severe mental health issues, advanced heart failure, conditions that prevent exercise, or serious coronary artery disease cannot participate.

What is being tested?

The study is testing a comprehensive prehabilitation program designed to prepare patients for surgery involving free flap reconstruction due to head and neck cancers. Prehabilitation includes various phases and methods aimed at improving recovery outcomes after the surgical procedure.

What are the potential side effects?

While not explicitly stated here, prehabilitation programs may include physical exercises which could lead to muscle soreness or fatigue. Any other side effects would depend on the specifics of the multimodal interventions included in this particular prehabilitation regimen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is a type of squamous cell carcinoma located in my head or neck.

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I am scheduled for surgery to remove a tumor or benign disease, with tissue reconstruction.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe heart artery disease.

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I have severe heart failure.

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I have a condition that prevents me from exercising.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up for reporting.