Exercise and Nutrition for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Marianne S Abouyared, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Davis

Disqualifiers: Cardiac conditions, Orthopedic disease, COPD, others

No Placebo Group

Approved in 1 Jurisdiction

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}

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.

Inclusion Criteria

I am over 18 and have been newly diagnosed with head and neck cancer.

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.

Trial 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 (Behavioral Intervention)

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).

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UC Davis Health Sacramento, CA

UC Davis Medical Center Sacramento, CA

Who Is Running the Clinical Trial?

University of California, Davis Lead Sponsor

References

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

Current Landscape of Nutrition Within Prehabilitation Oncology Research: A Scoping Review. [2023] Background: Prehabilitation aims to improve functional capacity prior to cancer treatment to achieve better psychosocial and clinical outcomes. Prehabilitation interventions vary considerably in design and delivery. In order to identify gaps in knowledge and facilitate the design of future studies, we undertook a scoping review of prehabilitation studies to map the range of work on prehabilitation being carried out in any cancer type and with a particular focus on diet or nutrition interventions. Objectives: Firstly, to describe the type of prehabilitation programs currently being conducted. Secondly, to describe the extent to which prehabilitation studies involved aspects of nutrition, including assessment, interventions, implementation, and outcomes. Eligibility Criteria: Any study of quantitative or qualitative design that employed a formal prehabilitation program before cancer treatment ("prehabilitation" listed in keywords, title, or abstract). Sources of Evidence: Search was conducted in July 2020 using MEDLINE, PubMed, EMBASE, EMCARE, CINAHL, and AMED. Charting Methods: Quantitative data were reported as frequencies. Qualitative nutrition data were charted using a framework analysis that reflects the Nutrition Care Process Model: assessment, intervention, and monitoring/evaluation of the nutrition intervention. Results: Five hundred fifty unique articles were identified: 110 studies met inclusion criteria of a formal prehabilitation study in oncology. prehabilitation studies were mostly cohort studies (41%) or randomized-controlled trials (38%) of multimodal (49%), or exercise-only (44%) interventions that were applied before surgery (94%). Nutrition assessment was inconsistently applied across these studies, and often conducted without validated tools (46%). Of the 110 studies, 37 (34%) included a nutrition treatment component. Half of these studies provided the goal for the nutrition component of their prehabilitation program; of these goals, less than half referenced accepted nutrition guidelines in surgery or oncology. Nutrition interventions largely consisted of counseling with dietary supplementation. The nutrition intervention was indiscernible in 24% of studies. Two-thirds of studies did not monitor the nutrition intervention nor evaluate nutrition outcomes. Conclusion: Prehabilitation literature lacks standardized and validated nutritional assessment, is frequently conducted without evidence-based nutrition interventions, and is typically implemented without monitoring the nutrition intervention or evaluating the intervention's contribution to outcomes. We suggest that the development of a core outcome set could improve the quality of the studies, enable pooling of evidence, and address some of the research gaps identified.

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

Nutritional prehabilitation in head and neck cancer: a systematic review. [2022] Prehabilitation affords an opportunity to support the management of malnutrition that is strongly associated with head and neck cancer. The purpose of this systematic review was to identify the components of nutritional prehabilitation interventions and their effects on nutritional and health outcomes in head and neck cancer patients.

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

Nutritional prehabilitation in head and neck cancer: A systematic review of literature. [2023] Malnutrition is a common problem among patients with head and neck cancer and can have adverse effects on overall health and treatment outcomes. Nutritional and physical prehabilitation are potential strategies to optimize the nutritional status of these patients. This systematic review aimed to identify and describe prehabilitative interventions that can promote an improvement in nutritional status.

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] To investigate the effect of pre-rehabilitation interventions such as nutrition and exercise for patients with head and neck cancer (HNC).

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

Clinical review of physical activity and functional considerations in head and neck cancer patients. [2021] Patients facing head and neck cancer treatment are profoundly vulnerable to physiologic and functional disability. Exercise and nutrition have been shown to have many benefits in cancer patients, but much of this work has been performed in groups of breast, colon, and prostate cancer patients. Limited data exists regarding the role of exercise and nutrition in the management of head and neck cancer patients given their unique set of challenges relating to the cancer as well as its treatment. In this paper, we review the existing literature about general or recreational physical exercise as well as nutrition in this patient population as it pertains to lean muscle body composition, functional well-being, and overall quality of life.

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

Prehabilitation in head and neck cancer patients: a literature review. [2021] Dysphagia is one consequence of head and neck cancer that has a significant impact on quality of life for head and neck cancer survivors. While survival rates continue to improve, focus has shifted to maximizing long-term function, with prevention or prehabilitation programs becoming more common. Prehabilitation programs typically include an exercise regime that specifies the exercise type, the number of repetitions to complete per set, the number of sets of each exercise to complete per day, as well as the length of the treatment block. Ideally, exercise programs are designed with principles of neuromuscular plasticity in mind.

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] Patients with head and neck cancer experience loss of weight and muscle mass, decreased functioning, malnutrition, depression, and declines in quality of life during and after treatment. The purpose of this exploratory randomized study was to determine the optimal timing for the initiation of a lifestyle and progressive resistance exercise training intervention (during or after radiation therapy), as determined by intervention adherence and by comparing between-group outcomes across 24 weeks.