Prehabilitation Program for Head and Neck Cancer

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a prehabilitation program designed to help people with head and neck cancer better manage the challenging treatments they face. The program aims to improve physical and emotional well-being by providing personalized education and support before cancer treatment begins. Participants are divided into two groups: one receives the prehabilitation program, and the other does not, to determine if the program truly makes a difference. Suitable candidates have been diagnosed with head and neck cancer and are preparing to start treatment with the goal of curing the cancer. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance cancer treatment preparation and support.

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 prior data suggests that this prehabilitation program is safe for head and neck cancer patients?

Research has shown that prehabilitation programs for head and neck cancer patients are generally manageable. Studies have found that these programs can reduce complications and shorten hospital stays by about four days. This indicates that the treatment is not only safe but may also speed up recovery.

Additionally, a review of exercise and nutrition prehabilitation demonstrated improvements in patient function, indicating safety and effectiveness. These studies did not specifically report any serious side effects or problems, which is encouraging for those considering trial participation. Overall, the evidence suggests that prehabilitation is a safe option for individuals undergoing treatment for head and neck cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the prehabilitation program for head and neck cancer because it represents a proactive approach to patient care. Unlike standard treatments, which typically focus on addressing the cancer itself through surgery, radiation, or chemotherapy, this program aims to prepare patients physically and psychologically before their main treatment begins. This can potentially improve treatment outcomes and enhance recovery. By equipping patients with tools and strategies to boost their overall health and resilience, this approach could lead to better quality of life and faster recovery times post-treatment.

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

Research has shown that prehabilitation programs can improve outcomes for patients with head and neck cancer. These programs typically include exercise, nutrition, and psychological support. In this trial, some participants will join a prehabilitation program, while others will be in a control arm without intervention. Studies have found that patients in prehabilitation often experience better results after treatment, such as improved physical abilities and overall well-being. For instance, they may perform better on tests like the 6-minute walk, which measures mobility. Patients also frequently see improvements in swallowing, speaking, and managing fatigue. This evidence suggests that prehabilitation can help patients cope with the challenging treatment process and enhance their quality of life. ^{2 4 6 7 8}

Who Is on the Research Team?

Cheryl Hysjulien, PsyD

Principal Investigator

Sanford Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8487197/

Pre-admission interventions (prehabilitation) to improve ...

To determine the benefits and harms of pre-admission interventions (prehabilitation) on postoperative outcomes in patients undergoing major elective surgery.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37897197/

Pre-rehabilitation interventions for patients with head and ...

Prehabilitation programs based on exercise, nutrition, or psychoeducation demonstrated improved post-interventional outcomes in HNC.

3.

bmjopen.bmj.com

bmjopen.bmj.com/content/15/7/e093832

An assessment of study characteristics, quality and ...

This scoping review describes the characteristics and quality of reporting of prehabilitation exercise interventions for adults living with cancer.

4.

researchgate.net

researchgate.net/publication/357558628_Prehabilitation_in_Head_and_Neck_Cancer_Surgery

Prehabilitation in Head and Neck Cancer Surgery

Prehabilitation interventions include optimization of cardiopulmonary function and comorbid conditions, provision of adequate nutrition, physical therapy, ...

5.

jamanetwork.com

jamanetwork.com/journals/jamasurgery/fullarticle/2698681

Effect of Exercise and Nutrition Prehabilitation on ...

Main Outcomes and Measures The primary outcome was change in functional capacity, measured with absolute change in 6-minute walk distance (6MWD) ...

6.

pmc.ncbi.nlm.nih.gov

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

Multimodal Prehabilitation in Head and Neck Cancer Patients ...

The objective of this study is to assess the feasibility of multimodal prehabilitation, which is composed of high‐intensity training, a protein‐enriched diet, ...

7.

researchgate.net

researchgate.net/publication/395368029_PREHABILITATION_IN_HEAD_AND_NECK_CANCER_A_NARRATIVE_REVIEW

PREHABILITATION IN HEAD AND NECK CANCER

Results: Multimodal prehabilitation was associated with reduced complication rates, shorter hospital stays (on average by four days), and ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0003999322001654

Systematic Review of Functional Outcomes in Cancer ...

These findings provide evidence supporting the efficacy of rehabilitative interventions for individuals with a cancer history.