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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial examines a group-mediated cognitive behavioral resistance exercise intervention in head and neck cancer patients who are undergoing chemoradiation treatment. Chemoradiation is the established standard of care for locally advanced head and neck cancer patients. However, many head and neck cancer patients experience clinically meaningful declines in muscle mass, physical function, and quality of life during and following treatment. Resistance exercise has been shown to improve muscle mass, body composition, and physical function when integrated with appropriate standard of care nutritional counseling/supplementation. This trial may help researchers determine the important of integrating exercise interventions with routine cancer care.

Research Team

Dukagjin Blakaj, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+