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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My cancer is a type of squamous cell carcinoma located in my head or neck.
Select...
I am scheduled for surgery to remove a tumor or benign disease, with tissue reconstruction.
Select...
I am 18 years old or older.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quality of life: Functional Assessment of Cancer Therapy-Head and Neck Version 4 (FACT-H&N)
Secondary outcome measures
Anxiety score: Hospital Anxiety and Depression Scale (HADS)
Depression score: Hospital Anxiety and Depression Scale (HADS)
Fatigue severity: Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F). Total score.
+13 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: PrehabilitationExperimental Treatment1 Intervention
- Tailored exercise prescription involving aerobic and resistance training, supported by a clinical exercise physiologist.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prehabilitation
2013
Completed Phase 3
~1040
Find a Location
Who is running the clinical trial?
University of CalgaryLead Sponsor
782 Previous Clinical Trials
845,793 Total Patients Enrolled
Nicole Culos-Reed, PhDPrincipal Investigatornculosre@ucalgary.ca
7 Previous Clinical Trials
4,237 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe heart artery disease.I have severe heart failure.My cancer is a type of squamous cell carcinoma located in my head or neck.I have a condition that prevents me from exercising.I am scheduled for surgery to remove a tumor or benign disease, with tissue reconstruction.I am 18 years old or older.I have approval from a clinical exercise specialist or doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Prehabilitation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies left for participants in this research endeavor?
"Enrolment is now open for this medical trial as per the records hosted on clinicaltrials.gov; which was initially shared on February 9th 2022 and saw its most recent update 18 days later."
Answered by AI
How many volunteers have enrolled in this clinical experiment?
"Affirmative. The records kept on clinicaltrials.gov indicate that this research is actively looking for participants. This trial was first posted on February 9th 2022, and the latest changes were made to it on February 18th 2022. 96 individuals are required from a single location."
Answered by AI
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