Exercise and Nutrition for Head and Neck Cancers

Overseen By Sylvia Crowder, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Pregnancy, Non-primary cancer, Surgery, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exercise and nutrition can aid individuals with head and neck cancers during and after treatment. Researchers are testing two approaches: one combines exercise with a special diet, while the other focuses solely on the diet. The goal is to determine how these methods might improve recovery and overall health. This trial suits those recently diagnosed with oral, throat, or voice box cancers, who will undergo radiation or chemoradiation treatment and can eat by mouth. As an unphased trial, it offers a unique opportunity to contribute to valuable research that could enhance recovery strategies for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the ENHANCE Intervention is safe for head and neck cancer patients?

Research shows that combining exercise and good nutrition benefits people with head and neck cancers. Studies have found these approaches improve both physical health and overall well-being. For example, a review of multiple studies found that nutrition and exercise programs significantly helped patients during treatment.

Regarding safety, activities like resistance training are generally safe and can help prevent or reduce long-term problems after cancer treatment. Good nutrition is also important because many head and neck cancer patients experience malnutrition, which can lead to more serious health issues.

In summary, exercise and nutrition programs are not only safe but also greatly benefit the health and recovery of head and neck cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ENHANCE intervention for head and neck cancers because it combines diet and exercise in a way that's tailored specifically to the unique challenges faced by these patients. Unlike standard care, which often focuses on surgery, radiation, and chemotherapy, the ENHANCE approach integrates supervised resistance training and a Mediterranean-inspired diet, addressing common issues like difficulty swallowing. Both treatment arms provide continuous activity tracking with a Fitbit, allowing for personalized adjustments. This holistic approach not only aims to support patients during treatment but also empowers them with tools and strategies for long-term health management.

What evidence suggests that this trial's treatments could be effective for head and neck cancer patients?

This trial will evaluate the effectiveness of combining exercise and nutrition for people with head and neck cancer. Research has shown that these approaches can improve both physical health and overall well-being. Participants in the "ENHANCE Intervention Diet and Exercise" arm will engage in supervised resistance training sessions and receive dietary coaching. Studies suggest these methods can lead to better results than not using them. Meanwhile, participants in the "ENHANCE Intervention Diet Only" arm will focus on nutritional guidance, which helps people eat better and can lead to improved health. Overall, these methods support recovery and enhance quality of life. ^{1 5 6 7 8}

Who Is on the Research Team?

Sylvia Crowder, PhD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

The ENHANCE Study is for adults over 18 with new diagnoses of oral, oropharyngeal, hypopharyngeal, or laryngeal cancers. Participants must be able to eat orally, speak and read English, have no major psychiatric disorders, and be cleared for physical activity. They should not be pregnant or scheduled for surgery and must consent to a Mediterranean diet.

Inclusion Criteria

Able to speak and read English

You can eat food by mouth.

I do not have any mental health conditions that would prevent me from participating.

Exclusion Criteria

I am currently pregnant.

I am scheduled for surgery.

My primary diagnosis is not head and neck cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo radiation therapy while receiving dietary interventions and supervised resistance training sessions

7 weeks

2 in-person visits per week

Post-Radiation Treatment

Participants continue with dietary coaching and switch to virtual resistance training sessions

5 weeks

2 virtual visits per week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including exit surveys and adherence assessments

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ENHANCE Intervention

Trial Overview This study tests an intervention combining exercise with a special diet versus just the dietary change alone in head and neck cancer patients. The goal is to design a program that improves health outcomes by integrating physical activity and nutrition.

How Is the Trial Designed?

Group I: ENHANCE Intervention Diet and Excerise Experimental Treatment 1 Intervention

Participants will participate in 2 in-person supervised resistance training sessions every week for the 7 weeks (during radiation), followed by 2 ZOOM video conference supervised resistance training sessions every week for 5 weeks (after radiation). During radiation, participants will be provided 15 meals each week for 7 weeks. Participants will also attend weekly dietary coaching sessions. Participants will receive a Fitbit to wear continuously 24/7 over 12-weeks to track steps and activity intensity.

Group II: ENHANCE Intervention Diet Only Experimental Treatment 1 Intervention

Participants will be provided 15 meals each week for 7 weeks that will accommodate common NIS concerns (ex. dysphagia and difficulty chewing) following an aMED dietary pattern (5 breakfast, 5 lunch, and 5 dinner), will be taught proper portion size, and will be asked to record percentages of each meal consumed in a provided food journal, in addition to any outside meals, snacks, or nutritional supplements. They will be provided with dietary coaching weekly to discuss NIS, aMED diet compliance, and set weekly SMART goals. Following completion of chemoradiotherapy (5 weeks), participants will be provided dietary coaching weekly (in-person or via videoconference), discuss NIS, aMED diet compliance at home, and set weekly SMART goals (30 min). Participants will receive a Fitbit to wear continuously 24/7 over 12-weeks to track steps and activity intensity.

Group III: Usual Care + Fitbit Active Control 1 Intervention

Participants will receive handouts with diet and exercise education. Participants will receive a Fitbit to wear continuously 24/7 over 12-weeks to track steps and activity intensity.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Published Research Related to This Trial

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 of 16 studies on head and neck cancer patients found that physical activity interventions are feasible, safe, and beneficial, leading to improvements in lean body mass, muscular strength, physical functioning, quality of life, and fatigue management.

The evidence suggests that engaging in physical activity can help mitigate the negative side effects of cancer and its treatment, although the studies varied widely in design and quality, indicating a need for further research to clarify the best types of interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of physical activity on health-related fitness and quality of life for patients with head and neck cancer: a systematic review. Capozzi, LC., Nishimura, KC., McNeely, ML., et al.[2018]

A supervised exercise program for patients with head and neck cancer, involving 144 participants, aims to prevent loss of lean body mass and improve quality of life, with sessions scheduled over 12 weeks before or after radiotherapy.

The pilot study indicates that the exercise program is feasible and safe, but attendance decreased over time, highlighting the need for strategies to enhance patient engagement and adherence to the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for the SEHNeCa randomised clinical trial assesing Supervised Exercise for Head and Neck Cancer patients. Rodriguez-Arietaleanizbeaskoa, M., Mojas Ereño, E., Arietaleanizbeaskoa, MS., 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]

Nutritional interventions during radiotherapy for head and neck cancer significantly improved body composition and physical function, with a notable effect size of 0.42 for body composition and 0.78 for physical function based on a meta-analysis of 13 randomized controlled trials involving 858 patients.

Combining nutrition and physical exercise interventions did not show significant benefits compared to control groups, indicating that future research should focus on larger trials to explore the potential of these combined approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and Nutrition Interventions in Patients with Head and Neck Cancer during Curative Treatment: A Systematic Review and Meta-Analysis. Bye, A., Sandmael, JA., Stene, GB., et al.[2021]

Before treatment for head and neck cancer, 62.2% of patients met UK physical activity guidelines, but this dropped to 40.1% after treatment, indicating a significant decline in physical activity levels post-diagnosis.

There is a positive correlation between post-treatment physical activity and quality of life, suggesting that engaging in physical activity may help improve the well-being of patients after head and neck cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participation in sport and physical activity in head and neck cancer survivors: associations with quality of life. Sammut, L., Fraser, LR., Ward, MJ., et al.[2017]

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]

Eighteen patients with stage III/IV head and neck cancer showed a significant decline in health-related quality of life (HRQoL) and physical functions after radical chemoradiotherapy, indicating the treatment's substantial impact on their overall well-being.

Despite the negative effects of treatment, 78% of patients recognized the benefits of exercise training and expressed willingness to participate in an exercise program, suggesting that exercise could be a valuable supportive care strategy for improving outcomes in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Impact of Cancer Treatment on Head and Neck Cancer Patients: FIT4TREATMENT. Leão, I., Garcia, C., Antunes, P., et al.[2022]

The exercise program for head and neck cancer patients undergoing chemoradiotherapy showed low overall adherence (54%) and retention (65%), indicating that while the program is feasible for some, it needs improvements to engage more patients effectively.

Despite the intention to counteract negative effects of treatment, significant declines in grip strength, fat-free mass, and quality of life were observed, suggesting that the current exercise intervention may not sufficiently mitigate the adverse impacts of chemoradiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a supervised and home-based tailored exercise intervention in head and neck cancer patients during chemoradiotherapy. Kok, A., Passchier, E., May, AM., et al.[2022]

The study involved 50 patients with head and neck cancer, with 41 (82%) agreeing to participate in an exercise and nutrition intervention during or after radiotherapy, showing that such interventions are feasible for this patient group.

The intervention during radiotherapy (EN-DUR) showed a trend toward reducing muscle mass loss, while the intervention after radiotherapy (EN-AF) also indicated potential benefits, suggesting that exercise and nutrition can help maintain muscle mass in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary effects of resistance training and nutritional supplements during versus after radiotherapy in patients with head and neck cancer: A pilot randomized trial. Sandmael, JA., Bye, A., Solheim, TS., et al.[2019]

Citations

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Exercise and Nutrition Interventions in Patients with Head and ... This meta-analysis found significantly positive effects of nutrition and physical exercise interventions alone in favor of the treatment groups.

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Exercise and Nutrition Interventions in Head and Neck ... Effectiveness of physical activity interventions in improving objective and patient-reported outcomes in head and neck cancer survivors: a ...

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Exercise and nutrition for head and neck cancer patients Therefore, the purpose of the present study is to examine the impact and timing of a 12-week PA and nutrition intervention (either during or following treatment) ...

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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 ...

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Exercise and nutrition for head and neck cancer patients Nutritional counseling has been found to improve dietary intake in patients who face increased risk of malnutrition, thereby improving outcomes ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12484345/

Physical activity in people affected by head and neck cancers Additional supportive-care data indicate that physical therapy can prevent or ameliorate long-term functional deficits after HNC treatment [46].

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Five-Year Mortality Outcomes for Eating As Treatment ... Malnutrition affects up to 80% of patients with head and neck cancer (HNC) and is associated with higher burden of disease, poorer treatment outcomes, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01332682

Resistance Training and Physical Functioning in Head ... The investigators hypothesize that patients receiving resistance training with nutritional counseling will demonstrate greater improvements in the outcomes when ...