Exercise and Nutrition for Head and Neck Cancer

Recruiting at 1 trial location

Overseen By Marianne Abouyared PI, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Cardiac conditions, Orthopedic disease, COPD, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a prehabilitation program, including exercise and nutrition guidance, can assist individuals with newly diagnosed head and neck cancer. Researchers seek to determine if this program is safe and acceptable for patients before surgery. Suitable candidates for this trial are those recently diagnosed with head and neck cancer who have not yet received treatment. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance pre-surgical care.

Will I have to stop taking my current medications?

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 exercise and nutrition programs before surgery are generally safe and well-tolerated for people with head and neck cancer. Studies have found that these programs improve patients' nutrition and overall health without major safety issues. One study found that these programs lowered the death rate and serious complications in patients. They also reduced hospital stays and problems with swallowing, which are common concerns. Overall, evidence suggests that combining exercise and nutrition before surgery is safe and beneficial for those preparing for head and neck cancer surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise and nutritional prehabilitation for head and neck cancer because it targets patient well-being before surgery, a phase often overlooked in traditional cancer care. Unlike standard treatments that primarily focus on the tumor, this approach emphasizes improving the patient's physical fitness and nutritional status, which could lead to better recovery and outcomes. By addressing these factors early, it has the potential to enhance surgery readiness and reduce complications, offering a holistic complement to conventional cancer therapies.

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

This trial will evaluate an exercise and nutritional prehabilitation program for head and neck cancer patients. Studies have shown that exercise and nutrition programs before treatment can improve health outcomes for these patients. Research indicates that these programs can significantly lower death rates, reduce serious complications, and help with swallowing problems. Patients also often experience shorter hospital stays. One study found that combining exercise with nutrition support improved recovery after surgery. These findings suggest that preparing with exercise and nutrition could effectively boost health and recovery for patients undergoing treatment for head and neck cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Marianne S Abouyared, MD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for individuals with head and neck cancers, including brain tumors and throat cancer. It's designed to see if preparing patients with exercise and nutrition programs before surgery can be safe and workable.

Exclusion Criteria

I have severe liver or kidney disease.

I have had surgery or radiation for head and neck cancer.

My health is very poor and I am at high risk for surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants engage in a 2-week home-based exercise and nutritional program before surgery

2 weeks

Weekly follow-up calls on day 7 and day 14

Surgery and Recovery

Participants undergo surgery and receive standard post-operative care

3-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

1 visit (in-person) approximately 1 month after surgery

What Are the Treatments Tested in This Trial?

Interventions

• Exercise and Nutritional Prehabilitation

Trial Overview The study is testing a 'prehabilitation' program that includes specific exercises and nutritional plans tailored for patients awaiting head and neck cancer surgery. The goal is to improve their overall condition before the operation.

How Is the Trial Designed?

Group I: behavioral intervention Experimental Treatment 1 Intervention

The study involves a behavioral intervention (exercise and nutritional prehabilitation) designed to assess outcomes related to feasibility, acceptability, and safety in head and neck cancer patients. Outcomes are being measured following the intervention over a defined period (from diagnosis through 1-month post-surgery).

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

A systematic review of 7 studies involving adults with head and neck cancer found that multimodal prehabilitation interventions, including nutritional counseling and swallowing exercises, effectively maintain caloric intake and body weight, while also improving swallowing ability and quality of life.

These prehabilitation strategies help reduce the risk of malnutrition and its adverse effects on treatment outcomes, highlighting their importance in the care of patients with head and neck cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional prehabilitation in head and neck cancer: A systematic review of literature. De Pasquale, G., Mancin, S., Matteucci, S., et al.[2023]

In a study of 60 head and neck cancer patients, initiating a progressive resistance exercise program during radiation therapy did not significantly improve body composition, although it did increase physical activity levels.

Delaying the exercise intervention until after treatment led to better adherence and showed improvements in fitness, quality of life, and nutritional status, highlighting the importance of timing in exercise interventions for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes, body composition, and nutrition status in patients with head and neck cancer: Results from an exploratory randomized controlled exercise trial. Capozzi, LC., McNeely, ML., Lau, HY., et al.[2022]

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]

Pre-rehabilitation interventions, particularly nutrition, significantly improved outcomes for head and neck cancer patients, leading to better weight retention, shorter hospital stays, and fewer postoperative complications based on a review of 31 studies.

Combining exercise with nutrition not only enhanced weight management and reduced complications but also significantly improved dysphagia, highlighting the importance of a comprehensive prehabilitation approach for better recovery in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-rehabilitation interventions for patients with head and neck cancers: A systematic review and meta-analysis. Seth, I., Bulloch, G., Qin, KR., et al.[2023]

A scoping review of 110 prehabilitation studies in cancer treatment revealed that while many interventions focus on multimodal or exercise-only approaches, only 34% included a nutrition component, highlighting a significant gap in nutritional integration.

The review found that nutritional assessments were often inconsistent and not based on validated tools, with two-thirds of studies failing to monitor or evaluate the effectiveness of nutrition interventions, suggesting a need for standardized practices in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Landscape of Nutrition Within Prehabilitation Oncology Research: A Scoping Review. Gillis, C., Davies, SJ., Carli, F., et al.[2023]

Exercise and nutrition can significantly improve lean muscle mass, functional well-being, and overall quality of life in patients with head and neck cancer, although most research has focused on other cancer types.

This review highlights the need for more targeted studies on exercise and nutrition specifically for head and neck cancer patients, as they face unique challenges that may affect their treatment and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical review of physical activity and functional considerations in head and neck cancer patients. Hunter, KU., Jolly, S.[2021]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2405457723021915

Nutritional prehabilitation in head and neck cancer Nutritional and physical prehabilitation interventions have a positive effect on the nutritional status and clinical outcomes of patients with head and neck ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11509296/

Head and Neck Cancer (HNC) Prehabilitation - PubMed Central [8] and including 31 articles, prehabilitation significantly decreased mortality rate, serious complication rate, dysphagia rate, and length of hospital stay ( ...

3. 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.

4. 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.

5. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2698681

Effect of Exercise and Nutrition Prehabilitation on ... This randomized clinical trial investigates the effect of an exercise and nutrition conditioning program (prehabilitation) vs usual care on ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10552833/

Nutritional interventions in prehabilitation for cancer surgery This review serves to highlight current evidence in the field of nutritional prehabilitation for cancer surgery, both as an independent strategy and as part of ...