Lifestyle Program for Head and Neck Cancer

(STRONGER Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Renown Health

Disqualifiers: Severe malnutrition, Cognitive conditions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a 20-week lifestyle program to determine its effectiveness in helping people with head and neck cancer feel better during chemoradiation therapy. The program includes nutrition counseling, exercise routines, and wellness education to reduce side effects, improve strength, and boost emotional well-being. It targets individuals with squamous cell carcinoma of the head and neck who can engage in light-to-moderate exercise and are about to begin chemoradiation treatment. Researchers aim to assess whether this program can make a difference and use the findings to plan a larger study in the future. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance quality of life during cancer treatment.

Do I need to stop my current medications for this trial?

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 this lifestyle program is safe for patients with head and neck cancer?

Research has shown that lifestyle programs with nutrition advice and exercise are generally safe for people with head and neck cancer. Studies indicate that these activities alone have positive effects and are well-tolerated. For example, a review of several studies found these programs helpful, with no major safety issues. One study demonstrated that a group exercise program was practical and safe, improving participants' quality of life. Overall, based on past evidence, the lifestyle program under study is likely safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this lifestyle program for head and neck cancer because it offers a holistic approach that combines nutrition, exercise, and wellness education, which is not a focus in traditional treatments. Unlike standard options that primarily involve surgery, radiation, or chemotherapy, this program emphasizes improving overall well-being through individualized nutrition plans, exercise routines, and stress management techniques. The inclusion of a Speech, Voice, Swallowing, and Airway Care series also uniquely addresses specific challenges faced by head and neck cancer patients, which are often overlooked in conventional treatments.

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

Research has shown that lifestyle programs focusing on healthy eating and exercise can benefit people with head and neck cancer. A review of several studies found that these programs can significantly improve recovery from treatment and quality of life. In this trial, participants will engage in a 20-week lifestyle program that includes working with a registered dietitian on nutrition, enhancing nutrition and overall well-being. Staying active through home-based exercises and daily walking can help manage symptoms and speed up recovery during and after cancer treatment. These findings suggest that structured lifestyle changes could support patients dealing with the challenges of chemoradiation therapy. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with head and neck cancers who are about to undergo or are currently undergoing chemoradiation therapy. The study aims to support these patients through a lifestyle program that includes nutrition, exercise, and wellness education.

Inclusion Criteria

Able to provide informed consent

I can do light to moderate exercise.

I am over 18 and have been diagnosed with squamous cell carcinoma of the head or neck.

Exclusion Criteria

Comorbidities that preclude safe participation in exercise

Cognitive or psychiatric conditions that impair study engagement

I need tube feeding due to severe malnutrition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 20-week lifestyle program including nutrition counseling, guided exercise, and wellness education during chemoradiation therapy

20 weeks

Weekly group sessions, home-based exercises twice per week, daily walking

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 20-Week Lifestyle Program

Trial Overview The intervention being tested is a 20-week lifestyle program designed to mitigate side effects of cancer treatment, enhance physical function and resilience, and improve quality of life during chemoradiation therapy for head and neck cancer patients.

How Is the Trial Designed?

Group I: Open Label Arm Experimental Treatment 1 Intervention

Participate in a 20-week lifestyle program that includes: * Nutrition counseling: Weekly group sessions with an oncology dietitian, including individualized calorie and protein goals. * Exercise: Home-based resistance and mobility exercises twice per week using online videos, and daily walking with self-tracking. * Wellness education: Weekly group sessions focused on stress management, sleep, fatigue, and mindset, facilitated by a health and wellness coach. Five of the 20 sessions will include a Speech, Voice, Swallowing, and Airway Care in Head \& Neck Cancer training series led by a speech pathologist.

Who Is Running the Clinical Trial?

Renown Health

Lead Sponsor

Trials

5

Recruited

2,006,000+

Citations

1. withpower.com withpower.com/trial/phase-head-and-neck-cancer-8-2025-ddb8f

Lifestyle Program for Head and Neck Cancer Participants undergo a 20-week lifestyle program including nutrition counseling, guided exercise, and wellness education during chemoradiation therapy. 20 weeks.

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

Physical activity in people affected by head and neck cancers People with head and neck cancers (HNCs) often experience deconditioning, nutritional challenges, and low adherence to physical activity ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3551727/

Exercise and nutrition for head and neck cancer patients Research on physical activity and nutrition interventions aimed at positively impacting symptom management, treatment-related recovery and quality of life ...

4. mdpi.com mdpi.com/2072-6643/12/11/3233

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

5. researchgate.net researchgate.net/publication/367566737_Systematic_Review_of_Nutrition_Interventions_to_Improve_Short_Term_Outcomes_in_Head_and_Neck_Cancer_Patients

Systematic Review of Nutrition Interventions to Improve ... Nutrition counseling by a registered dietitian leads to improved nutrition status and QOL. Further research is needed to determine best ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7690392/

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.

7. link.springer.com link.springer.com/article/10.1007/s00520-023-08126-2

Effect of exercise across the head and neck cancer ... This study aims to systematically explore the impact of physical exercise as supportive therapy for head and neck cancer.

8. journals.sagepub.com journals.sagepub.com/doi/10.1177/02601060221106624

Lifestyle choices following head and neck cancer treatment 80% of participants made lifestyle changes following HNC treatment. The most prevalent changes were to diet and alcohol intake. Key motivators ...

9. researchgate.net researchgate.net/publication/266253766_A_clinic-supported_group_exercise_program_for_head_and_neck_cancer_survivors_managing_cancer_and_treatment_side_effects_to_improve_quality_of_life

A clinic-supported group exercise program for head and ... Results: Overall, this program was feasible, as indicated by recruitment, adherence, and safety outcomes. Survivors experienced improved acute ...