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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special program called prehabilitation, which strengthens individuals before surgery for head and neck cancer. The program includes personalized exercise plans with activities like aerobic and resistance training, designed by a clinical exercise physiologist. It targets individuals diagnosed with certain types of head and neck cancer who are scheduled for surgery with free flap reconstruction. Participants should be able to perform exercises and understand English. The goal is to determine if physical preparation before surgery improves recovery and outcomes. As an unphased study, this trial offers a unique opportunity to potentially enhance recovery and surgical outcomes through personalized prehabilitation.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this prehabilitation intervention is safe for head and neck cancer surgery patients?

Research has shown that exercises before surgery, known as prehabilitation, are generally safe for people with head and neck cancer. In various studies, patients who participated in prehabilitation programs experienced improved physical and mental health, indicating that the exercises were well-tolerated. No major harm was reported from the exercise routines.

Prehabilitation typically includes aerobic exercises, which increase heart rate, and resistance exercises, which strengthen muscles. These exercises are widely used and considered safe for most people. Overall, evidence suggests that prehabilitation is a safe option for patients preparing for surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for head and neck cancer, which often focus on surgical intervention, chemotherapy, or radiation, prehabilitation offers a proactive approach to patient care. This method involves tailored exercise programs, including aerobic and resistance training, designed to improve a patient's physical fitness before undergoing surgery. Researchers are excited about prehabilitation because it has the potential to enhance recovery rates, reduce postoperative complications, and improve overall outcomes for patients by preparing their bodies to better withstand the stresses of surgery.

What evidence suggests that prehabilitation is effective for head and neck cancer surgery?

Studies have shown that prehabilitation, which participants in this trial will receive, can help people with head and neck cancer prepare for surgery. It typically includes exercise plans with aerobic activities to improve heart and lung health and resistance exercises to build muscle strength. Research suggests that those who undergo prehabilitation may experience better surgical outcomes and faster recovery. Specifically, patients have reported feeling stronger, enjoying better mental health, and experiencing a higher quality of life. This preparation period builds resilience, making surgery and recovery easier to manage. ^{2 4 5 6 7}

Who Is on the Research Team?

Nicole Culos-Reed, PhD

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11950714/

Multimodal Prehabilitation in Head and Neck Cancer Patients ... This study describes the first results of the introduction of multimodal prehabilitation in head and neck cancer surgery patients. This ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11635136/

Impact of Preoperative Multidisciplinary Conference on Head ... A preoperative multidisciplinary conference improves operative efficiency and postoperative outcomes of head and neck microvascular free flap reconstructions.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2161831325000286

Prehabilitation Strategies: Enhancing Surgical Resilience ... These include functional outcomes, patient-reported outcomes, return to work, physical performance, mental health indicators like depression and anxiety, and ...

4. mdpi.com mdpi.com/2077-0383/13/20/6176

Head and Neck Cancer (HNC) Prehabilitation: Advantages ... Cancer prehabilitation is the process between the time of cancer diagnosis and the beginning of the active acute treatment.

5. journalotohns.biomedcentral.com journalotohns.biomedcentral.com/articles/10.1186/s40463-020-00486-7

Prehabilitation in head and neck cancer patients: a literature ... This review of the literature has shed light on the variability of prehabilitation timing, exercise type, dose, duration of treatment, and outcomes.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38012345/

Multiphasic exercise prehabilitation for patients undergoing ... Multiphasic exercise prehabilitation for patients undergoing surgery for head and neck cancer: a hybrid effectiveness-implementation study ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/hed.27561

Pre‐rehabilitation interventions for patients with head and ... Prehabilitation programs based on exercise, nutrition, or psychoeducation demonstrated improved post-interventional outcomes in HNC.