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.
PRIMARY OBJECTIVES: I. To determine the feasibility of implementing a group-mediated cognitive behavioral (GMCB) personalized resistance exercise (RE) intervention in head and neck cancer (HNCa) patients undergoing chemoradiation (CRT). II. To examine the effects of GMCB RE intervention upon functional limitations, body composition, and quality of life (QOL) in HNCa patients undergoing CRT. OUTLINE: 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 twice weekly (BIW) in weeks 1-8, once a week (QW) in weeks 9-12, and then twice a month in weeks 13-24.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
Receive group-based behavioral counseling
Receive dietary counseling
Ancillary studies
Ancillary studies
Undergo personalized resistance exercises
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Recruitment rates
Number of patients agreed to participate by signing the informed consent
Time frame: At baseline
Adherence of Intervention
Adherence will be defined via session attendance and compliance with the prescribed sets, repetitions, and loads of the RE prescription as assessed using exercise logs, upon which participants will record all exercise performed at the center or independently..
Time frame: At 3-month
Adherence of Intervention
Adherence will be defined via session attendance and compliance with the prescribed sets, repetitions, and loads of the RE prescription as assessed using exercise logs, upon which participants will record all exercise performed at the center or independently..
Time frame: At 6-month
Incidence of adverse events
Monitored by direct observation and or patient reporting of signs and symptoms using NCI CTCAE version 5
Time frame: At 3-month
Incidence of adverse events
Monitored by direct observation and or patient reporting of signs and symptoms using NCI CTCAE version 5
Time frame: At 6-month
Retention rates
Rates will be calculated prospectively throughout the trial
Time frame: At 3-month
Retention rates
Rates will be calculated prospectively throughout the trial
Time frame: At 6-month
Functional Battery
Functional Battery Objective Functional Performance will be assessed using 3 valid and reliable timed performance-related mobility tasks: 400-meter walk (the primary outcome), stair-climb, and lift and carry task. Assessments of Mobility-Related Self-Efficacy to complete each functional task will also be completed with the tests.
Time frame: At 3-month
Functional Battery
Functional Battery Objective Functional Performance will be assessed using 3 valid and reliable timed performance-related mobility tasks: 400-meter walk (the primary outcome), stair-climb, and lift and carry task. Assessments of Mobility-Related Self-Efficacy to complete each functional task will also be completed with the tests.
Time frame: At 6-month
Patient Reported Outcomes (Quality of Life/Fatigue/Physical Function)
QoF will be assessed using both global and disease-specific measures including the satisfaction with life scale, the SF-12, the Functional Assessment of Cancer Therapy - Head and Neck (FACT - HN) and the EORTC Quality of Life scale. Fatigue symptoms will be assessed with the Brief Fatigue Inventory (BFI).
Time frame: At 3-month
Patient Reported Outcomes (Quality of Life/Fatigue/Physical Function)
QoF will be assessed using both global and disease-specific measures including the satisfaction with life scale, the SF-12, the Functional Assessment of Cancer Therapy - Head and Neck (FACT - HN) and the EORTC Quality of Life scale. Fatigue symptoms will be assessed with the Brief Fatigue Inventory (BFI).
Time frame: At 6-month
Muscular strength
Muscular strength will be assessed using standardized one-repetition maximum testing protocols for the chest press and leg extension exercises.
Time frame: At 3-month
Muscular strength
Muscular strength will be assessed using standardized one-repetition maximum testing protocols for the chest press and leg extension exercises.
Time frame: At 6-month
Anthropometric measurements
Anthropometric measurements are a series of quantitative measurements of the muscle, bone, and adipose tissue used to assess the composition of the body. The core elements of anthropometry are height, weight, body mass index (BMI), body circumferences (waist, hip, and limbs), and skinfold thickness. Anthropometric measurements will be taken in a consultation room to ensure the privacy of the participant.
Time frame: At 3-month
Anthropometric measurements
Anthropometric measurements are a series of quantitative measurements of the muscle, bone, and adipose tissue used to assess the composition of the body. The core elements of anthropometry are height, weight, body mass index (BMI), body circumferences (waist, hip, and limbs), and skinfold thickness. Anthropometric measurements will be taken in a consultation room to ensure the privacy of the participant.
Time frame: At 6-month
Body composition
Body composition will be assessed using dual-energy x-ray absorptiometry (DEXA; GE Health Care Lunar, Madison, WI) for all outcome measures. The DEXA scans will be used to determine total body composition including bone-mineral density, as well as, percentage body fat and fat-free mass for all body regions.
Time frame: At 3-month
Body composition
Body composition will be assessed using dual-energy x-ray absorptiometry (DEXA; GE Health Care Lunar, Madison, WI) for all outcome measures. The DEXA scans will be used to determine total body composition including bone-mineral density, as well as, percentage body fat and fat-free mass for all body regions.
Time frame: At 6-month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.