20 Participants Needed

Exercise and Nutrition for Head and Neck Cancer

Recruiting at 1 trial location
RS
MA
Overseen ByMarianne Abouyared PI, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Davis
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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.12345

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.23456

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.23457

Research Team

MS

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.
See 9 more

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
1Treatment groups
Experimental Treatment
Group I: behavioral interventionExperimental Treatment1 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

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

References

Current Landscape of Nutrition Within Prehabilitation Oncology Research: A Scoping Review. [2023]
Nutritional prehabilitation in head and neck cancer: a systematic review. [2022]
Nutritional prehabilitation in head and neck cancer: A systematic review of literature. [2023]
Pre-rehabilitation interventions for patients with head and neck cancers: A systematic review and meta-analysis. [2023]
Clinical review of physical activity and functional considerations in head and neck cancer patients. [2021]
Prehabilitation in head and neck cancer patients: a literature review. [2021]
Patient-reported outcomes, body composition, and nutrition status in patients with head and neck cancer: Results from an exploratory randomized controlled exercise trial. [2022]
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