Menu
Peptide Database
Results
No peptides found
Featured

Use search to browse all 100+ peptides

Completed NA INTERVENTIONAL NCT04733495

Group-Mediated Cognitive Behavioral Resistance Exercise Intervention in Head and Neck Cancer Patients Undergoing Chemoradiation Treatment

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

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.

Detailed Description

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.

Interventions

Name: Counseling
Type: OTHER
Description: Receive group-based behavioral counseling
Name: Dietary Counseling and Surveillance
Type: BEHAVIORAL
Description: Receive dietary counseling
Name: Quality-of-Life Assessment
Type: OTHER
Description: Ancillary studies
Name: Questionnaire Administration
Type: OTHER
Description: Ancillary studies
Name: Resistance Training
Type: OTHER
Description: Undergo personalized resistance exercises

Primary Outcomes

Measure: Recruitment rates
TimeFrame: At baseline
Description: Number of patients agreed to participate by signing the informed consent
Measure: Adherence of Intervention
TimeFrame: At 3-month
Description: 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..
Measure: Adherence of Intervention
TimeFrame: At 6-month
Description: 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..
Measure: Incidence of adverse events
TimeFrame: At 3-month
Description: Monitored by direct observation and or patient reporting of signs and symptoms using NCI CTCAE version 5
Measure: Incidence of adverse events
TimeFrame: At 6-month
Description: Monitored by direct observation and or patient reporting of signs and symptoms using NCI CTCAE version 5
Measure: Retention rates
TimeFrame: At 3-month
Description: Rates will be calculated prospectively throughout the trial
Measure: Retention rates
TimeFrame: At 6-month
Description: Rates will be calculated prospectively throughout the trial
Measure: Functional Battery
TimeFrame: At 3-month
Description: 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.
Measure: Functional Battery
TimeFrame: At 6-month
Description: 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.
Measure: Patient Reported Outcomes (Quality of Life/Fatigue/Physical Function)
TimeFrame: At 3-month
Description: 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).
Measure: Patient Reported Outcomes (Quality of Life/Fatigue/Physical Function)
TimeFrame: At 6-month
Description: 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).
Measure: Muscular strength
TimeFrame: At 3-month
Description: Muscular strength will be assessed using standardized one-repetition maximum testing protocols for the chest press and leg extension exercises.
Measure: Muscular strength
TimeFrame: At 6-month
Description: Muscular strength will be assessed using standardized one-repetition maximum testing protocols for the chest press and leg extension exercises.
Measure: Anthropometric measurements
TimeFrame: At 3-month
Description: 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.
Measure: Anthropometric measurements
TimeFrame: At 6-month
Description: 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.
Measure: Body composition
TimeFrame: At 3-month
Description: 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.
Measure: Body composition
TimeFrame: At 6-month
Description: 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.

Trial Information

NCT ID

NCT04733495

Status

Completed

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Ohio State University Comprehensive Cancer Center

Last Updated

December 15, 2025