Prehabilitation for Head and Neck Cancer Surgery

Overseen By Rosemary C Twomey, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Neurological, Musculoskeletal, Psychotic, Addictive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

96 Participants Needed

Trial Summary

What is the purpose of this trial?

Implementing a multiphasic, multimodal prehabilitation intervention for people undergoing surgery with free flap reconstruction for the treatment of head and neck cancer.

Research Team

Nicole Culos-Reed, PhD

Principal Investigator

[e-mail]

Eligibility Criteria

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.

Inclusion Criteria

Ability to provide written informed consent and understand study information in English

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

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

Exclusion Criteria

I have severe heart artery disease.

I have severe heart failure.

Diagnosed psychotic, addictive, or major cognitive disorders

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo a multiphasic exercise prehabilitation program involving aerobic and resistance training, supported by a clinical exercise physiologist

Pre-surgery period

Surgery and Hospitalization

Participants undergo surgery for head and neck cancer with free flap reconstruction and are monitored during the hospital stay

10-14 days

Post-operative Recovery

Participants are monitored for recovery, including mobilization and step counts, during the immediate post-operative period

0-6 weeks after hospital discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life, physical activity, and symptom burden

12 months

Treatment Details

Interventions

• Prehabilitation

Trial Overview 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.

Participant Groups

Group I: Prehabilitation Experimental Treatment 1 Intervention

- Tailored exercise prescription involving aerobic and resistance training, supported by a clinical exercise physiologist.

Prehabilitation is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Approved in United States as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Approved in Canada as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+