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

Trial Summary

What is the purpose of this trial?

This study examines the acceptability, feasibility, and safety in developing a prehabilitation program for head and neck cancer patients. The purpose of this research is to access the safety and acceptability of using a prehabilitation program before head and neck cancer surgery.

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 data supports the effectiveness of the treatment Exercise and Nutritional Prehabilitation, Preoperative Rehabilitation, Prehabilitation Program, Nutritional and Physical Prehabilitation for head and neck cancer?

Research suggests that nutritional and physical prehabilitation can help improve the nutritional status and overall health of head and neck cancer patients, potentially leading to better treatment outcomes. Although much of the evidence comes from studies on other types of cancer, these interventions are believed to support patients by addressing malnutrition and enhancing physical function. ^{1 2 3 4 5}

Is exercise and nutritional prehabilitation safe for humans?

Exercise and nutritional prehabilitation have been studied in various cancer patients, including those with breast, colon, and prostate cancer, and are generally considered safe. These interventions aim to improve nutritional status and physical function, which can support overall health and quality of life. ^{2 3 4 5 6}

How is the Exercise and Nutritional Prehabilitation treatment different from other treatments for head and neck cancer?

This treatment is unique because it focuses on improving nutritional status and physical fitness before surgery, which can help manage malnutrition and enhance recovery. Unlike standard treatments that primarily target the cancer itself, this approach aims to strengthen the body to better withstand the stress of cancer treatment. ^{2 3 4 5 7}

Research Team

Marianne S Abouyared, MD

Principal Investigator

University of California, Davis

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Current Landscape of Nutrition Within Prehabilitation Oncology Research: A Scoping Review. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

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

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

Nutritional prehabilitation in head and neck cancer: A systematic review of literature. [2023]

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

Pre-rehabilitation interventions for patients with head and neck cancers: A systematic review and meta-analysis. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Clinical review of physical activity and functional considerations in head and neck cancer patients. [2021]

6. England pubmed.ncbi.nlm.nih.gov

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

7. United States 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. [2022]