Prehabilitation Program for Head and Neck Cancer

Recruiting at 1 trial location

Overseen By Amy Schmidt, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sanford Health

Disqualifiers: Cardiac arrhythmia, Implanted devices, Pregnancy, others

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

Compensation: Varies

Number of Visits: 8

Duration: 6 months

80 Participants Needed

Trial Summary

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

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Prehabilitation Program for Head and Neck Cancer?

Research suggests that prehabilitation programs, which often include exercise and nutritional support, can help improve recovery and manage malnutrition in head and neck cancer patients. These programs are designed to enhance physical function and overall health before surgery, potentially leading to better outcomes. ^{1 2 3 4 5}

Is the Prehabilitation Program safe for humans?

Prehabilitation programs, which often include exercise and nutritional support, have been studied in various types of cancer and are generally considered safe for humans. These programs aim to improve patients' health before surgery and have not been associated with significant safety concerns in the research reviewed. ^{1 2 4 6 7}

How is the prehabilitation program treatment for head and neck cancer different from other treatments?

The prehabilitation program for head and neck cancer is unique because it focuses on preparing patients before surgery through nutritional support and exercise, aiming to improve their overall health and recovery. Unlike standard treatments that focus on the cancer itself, this program emphasizes enhancing the patient's physical condition and quality of life before treatment begins. ^{1 2 4 5 8}

What is the purpose of this trial?

Head and neck cancer accounts for 3% of malignancies in the United States. However, the diagnosis and treatment for head and neck cancer is considered to be debilitating. Not because of its morbidity, but due to the extremely rigorous treatment course which has a profound impact on patients physical, social, and emotional functioning. Disfigurement and sensorimotor deficits further compound this impact. Head and neck cancer patients contend with treatments that can significantly affect their quality of life. Treatment regularly results in decreased functional capacity and decreased quality of life. Physical impairments are manifested through, but not limited to, disfigurement, deconditioning, communication issues, "swallowing, speech, breathing, and cancer-related fatigue". Premorbid factors such as preexisting anxiety and depression, chemical dependency, financial barriers, and lack of social support system are unique obstacles to the head and neck cancer population impacting treatment and outcomes. Due to these factors, patients experience higher rates of anxiety and depression, psychological distress, and fear of cancer recurrence. In fact, "compared with other survivors of cancer, head and neck cancer survivors are almost 2 times more likely to die from suicide". In view of the aforementioned research, Roger Maris Cancer Center's head and neck cancer will implement a prehabilitation program that evaluates each patient using standardized screening tools and provide personalized education and interventions. This project evaluates a more comprehensive and proactive multidisciplinary approach to improve treatment and outcomes in head and neck cancer patients.

Research Team

Cheryl Hysjulien, PsyD

Principal Investigator

Sanford Health

Eligibility Criteria

This trial is for adults over 18 with a diagnosis of head and neck cancer who are seeking treatment aimed at curing their disease. They must be able to consent to participate. It's not open to those over 375 lbs, with metal allergies, certain heart conditions, pregnant women, or individuals with implanted electronic devices.

Inclusion Criteria

Willing and able to provide written consent

I am currently seeking treatment to cure my cancer.

I have been diagnosed with head and neck cancer.

Exclusion Criteria

You are currently receiving treatment with an external defibrillator.

Pregnant women (per BIS instructions for use, pregnant women should not participate)

Patient weight exceeding 375 lbs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo a prehabilitation program that includes standardized screening tools and personalized education and interventions

8 weeks

Regular visits for assessments and interventions

Treatment

Participants receive standard treatment for head and neck cancer

6 months

Multiple visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up visits at 8 weeks and 6 months post-treatment

Treatment Details

Interventions

• Prehabilitation Program

Trial Overview The study is testing a prehabilitation program designed for patients with head and neck cancer. The program includes personalized education and interventions based on standardized screenings aiming to improve physical, social, and emotional functioning before starting rigorous treatments.

Participant Groups

Group I: Prospective Control Active Control 1 Intervention

Prospectively enrolling patients to a control arm with no intervention.

Group II: Prospective Prehabilitation Active Control 1 Intervention

Prospectively enrolling patients into a prehabilitation program for head and neck cancer.

Who Is Running the Clinical Trial?

Sanford Health

Lead Sponsor

Trials

53

Recruited

2,067,000+

University of North Dakota

Collaborator

Trials

17

Recruited

1,200+

Findings from Research

A systematic review identified only two studies on nutritional prehabilitation in head and neck cancer patients, both using an 'enriched formula' for malnourished individuals prior to surgery.

The studies found that this enriched nutritional intervention did not significantly improve outcomes such as weight loss, physical function, or surgical complications compared to standard nutritional formulas, highlighting a need for more robust research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional prehabilitation in head and neck cancer: a systematic review. Cantwell, LA., Fahy, E., Walters, ER., et al.[2022]

Prehabilitation programs for patients undergoing major abdominal cancer surgery include a mix of exercise, nutritional, and psychological interventions, but their composition and delivery methods vary widely across studies, indicating a need for standardization.

In a review of 9 studies involving 549 patients, no significant differences in post-operative complications were found between prehabilitation and standard care, suggesting that while prehabilitation may optimize recovery, its impact on reducing complications needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of prehabilitation programs in abdominal cancer surgery. Hijazi, Y., Gondal, U., Aziz, O.[2022]

The study demonstrated that it is feasible to measure patient-reported outcomes (PROs) and in-hospital mobilization in head and neck cancer patients throughout their surgical timeline, with high completion rates for baseline and in-hospital assessments.

However, assessing physical function before surgery proved challenging, indicating a need for improved methods to gather this data, which is crucial for developing effective prehabilitation programs for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of patient-reported outcomes, physical function, and mobilization in the care pathway for head and neck cancer surgical patients. Daun, JT., Twomey, R., Capozzi, LC., et al.[2023]

A systematic review of 25 randomized-controlled trials involving 2682 cancer patients found that prehabilitation programs focusing on exercise training did not show clear benefits over usual care in improving health-related quality of life or reducing postoperative complications.

The overall certainty of the evidence was assessed as very low due to serious methodological concerns, indicating that more research is needed to determine the true effectiveness of prehabilitation programs for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. Meneses-Echavez, JF., Loaiza-Betancur, AF., Díaz-López, V., et al.[2023]

Prehabilitation programs for head and neck cancer survivors can help improve swallowing function and quality of life, but there is significant variability in how these programs are defined and implemented, with one-third focusing on exercises before treatment and two-thirds during treatment.

Common exercises include the Mendelsohn's maneuver and effortful swallow, typically prescribed at 10 repetitions, three times a day during radiation therapy, but the lack of standardization makes it challenging to determine the most effective approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation in head and neck cancer patients: a literature review. Loewen, I., Jeffery, CC., Rieger, J., et al.[2021]

In a study of 67 oesophageal cancer patients, a personalized pre-operative exercise program helped maintain and even improve cardiorespiratory fitness during neoadjuvant chemotherapy, with significant increases noted just before surgery.

Higher adherence to the exercise program and greater volumes of physical activity were linked to a lower risk of post-operative pneumonia, emphasizing the importance of consistent exercise during prehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Pre-operative Exercise and the Response to Prehabilitation in Oesophageal Cancer Patients. Halliday, LJ., Doganay, E., Wynter-Blyth, V., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Nutritional prehabilitation in head and neck cancer: a systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A systematic review of prehabilitation programs in abdominal cancer surgery. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The feasibility of patient-reported outcomes, physical function, and mobilization in the care pathway for head and neck cancer surgical patients. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Prehabilitation in head and neck cancer patients: a literature review. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Adherence to Pre-operative Exercise and the Response to Prehabilitation in Oesophageal Cancer Patients. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Optimizing classical risk scores to predict complications in head and neck surgery: a new approach. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Cancer Prehabilitation Programs and Their Effects on Quality of Life [2019]