Cognitive Behavioral Resistance Exercise for Head and Neck Cancer

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Severe heart disease, Other cancer, Musculoskeletal/Neurological disorder, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a combination of resistance exercises (also known as strength training or weight training), dietary counseling, and behavioral support can aid those with head and neck cancer undergoing chemoradiation. The researchers aim to determine if these exercises can improve muscle mass, physical function, and overall quality of life during cancer treatment. They seek participants with HPV-positive stage III-IV head and neck cancer who are already receiving chemotherapy and radiation therapy. This trial suits individuals medically cleared for resistance exercises who wish to maintain or improve their physical health during treatment. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance supportive care 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 your doctor or the trial coordinators.

What prior data suggests that this resistance exercise intervention is safe for head and neck cancer patients?

Research has shown that resistance training is generally safe for people with head and neck cancer. Studies have found that it can increase muscle mass and improve physical abilities. One study focused on heavy lifting and found it both feasible and safe for cancer survivors. Participants managed the exercises well, with no serious side effects reported. Another study suggested that resistance training can effectively prevent muscle loss in cancer patients, especially when supervised. Overall, resistance training appears to be a well-tolerated method to enhance physical health in cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining cognitive behavioral resistance exercise with supportive care for head and neck cancer because it offers a holistic, non-pharmacological approach that addresses both physical and mental well-being. Unlike traditional treatments like surgery, chemotherapy, or radiation, which directly target cancer cells, this method focuses on improving patients' strength and quality of life through personalized resistance exercises. Additionally, the integration of dietary and behavioral counseling aims to empower patients with skills to manage their health beyond the physical symptoms of cancer, potentially enhancing overall treatment outcomes and long-term recovery.

What evidence suggests that resistance training is effective for head and neck cancer patients?

Research has shown that strength training benefits people with head and neck cancer. Studies have found that this exercise helps cancer patients build muscle and enhance physical abilities, even during treatment. One study found that strength training prevents muscle loss, which often occurs during chemotherapy and radiation. Another study showed that patients who engaged in strength training became stronger and improved their overall physical health. In this trial, participants will undergo personalized resistance exercises and receive dietary counseling. Combined with nutrition advice, this exercise might help patients maintain or even improve their quality of life during cancer treatment. ^{1 2 4 6 7}

Who Is on the Research Team?

Dukagjin Blakaj, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with head and neck cancer, specifically HPV+ stage III-IV squamous cell carcinomas, who are undergoing chemoradiation. They must be cleared by their doctor to do resistance exercises and have no severe heart conditions or other medical issues that make exercise unsafe. Pregnant or nursing women and those with prior cancers not eligible.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent

Receive medical clearance to participate from treating primary care physician or Medical Oncologists

I don't have severe heart disease or other conditions that make exercise unsafe.

Exclusion Criteria

I have a condition that makes it unsafe for me to exercise.

I have a severe heart condition or other serious illness that prevents me from exercising.

Pregnant or nursing women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo personalized resistance exercises daily, receive dietary counseling weekly, and group-based behavioral counseling over 24 weeks

24 weeks

Daily exercise sessions, weekly dietary counseling, and bi-weekly to monthly behavioral counseling

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Resistance Training

Trial Overview The study tests a cognitive-behavioral program combined with resistance training during standard chemoradiation treatment for head and neck cancer patients. It aims to see if this approach helps maintain muscle mass, physical function, and quality of life.

How Is the Trial Designed?

Group I: Supportive care (resistance exercise, counseling) Experimental Treatment 5 Interventions

Patients undergo personalized resistance exercises over 1 hour daily. Patients receive dietary counseling over 60 minutes at week 1 and then over 15-30 minutes weekly for up to 6 weeks. Patients also receive group-based behavioral counseling BIW in weeks 1-8, QW in weeks 9-12, and then twice a month in weeks 13-24.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10625510/

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

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12244484/

Feasibility and preliminary efficacy of heavy Lifting Strength ... Here, we propose the Feasibility and Preliminary Efficacy of Heavy Lifting Strength Training versus Usual Care in Head and Neck Cancer Survivors ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1040842821001591

Muscle hypertrophy in cancer patients and survivors via ... Resistance training can counteract the loss of muscle mass in cancer patients. Especially in a supervised setting.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01332682

Resistance Training and Physical Functioning in Head ... The purpose of this feasibility study is to examine the safety and effect of resistance training on muscle strength, lean body mass, physical functioning, ...

5. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.30901

Feasibility and preliminary effects of resistance training and ... The objective of the current study was to evaluate the feasibility of an exercise and nutrition intervention during radiotherapy (RT) compared with after RT.

6. link.springer.com link.springer.com/article/10.1007/s00520-023-07815-2

Feasibility and safety of Heavy Lifting Strength Training in ... The primary aim of the LIFTING trial was to examine the feasibility and safety of a HLST program in HNCS ≥1-year post-surgical neck dissection.

7. nature.com nature.com/articles/s41416-020-0921-8

Resistance training and total and site-specific cancer risk Resistance training was associated with lower risk of bladder and kidney cancers. Future studies are warranted to confirm our findings.