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

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

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.

Study Overview

• Status: Completed
• Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Counseling; Behavioral: Dietary Counseling and Surveillance; Other: Resistance Training

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with locally advanced human papillomavirus (HPV)+ stage III-IV head and neck (HN) squamous cell carcinomas undergoing concurrent chemotherapy and radiation therapy. Patients with prior cancers or post-surgical patients needing adjuvant therapy will not be allowed to participate in this study
• Undergoing planned course of standard of care CRT for a total of 33 to 35 RT fractions (six and a half or seven weeks of treatment)
• Adults 18 years old (yo) or older who have clearance from their primary care provider (PCP) or medical oncologist to participate in resistance exercises during treatment. These patients will be monitored very closely on a weekly basis during the trial
• All participants must be free of severe heart or systemic disease or medical contraindications that would make supervised RE participation unsafe
• Receive medical clearance to participate from treating primary care physician or Medical Oncologists
• Ability to understand and the willingness to sign a written informed consent
• Willing and physically able to participate in RE

Exclusion Criteria:

• Severe heart or systemic disease or medical contraindications to exercise
• Diagnosis of cancer other than HNCa
• Musculoskeletal/Neurological disorder inhibiting them from safe exercise
• Pregnant or nursing women
• Unable to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supportive care (resistance exercise, counseling); 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.

Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Counseling; Receive group-based behavioral counseling; Other Names: Counseling Intervention; Behavioral: Dietary Counseling and Surveillance; Receive dietary counseling; Other: Resistance Training; Undergo personalized resistance exercises; Other Names: Strength Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rates	Number of patients agreed to participate by signing the informed consent	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..	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..	At 6-month
Incidence of adverse events	Monitored by direct observation and or patient reporting of signs and symptoms using NCI CTCAE version 5	At 3-month
Incidence of adverse events	Monitored by direct observation and or patient reporting of signs and symptoms using NCI CTCAE version 5	At 6-month
Retention rates	Rates will be calculated prospectively throughout the trial	At 3-month
Retention rates	Rates will be calculated prospectively throughout the trial	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.	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.	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).	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).	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.	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.	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.	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.	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.	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.	At 6-month

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Dukagjin Blakaj, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2021
• Primary Completion (Actual): May 22, 2022
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Health Care Quality, Access, and Evaluation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Investigative Techniques; Epidemiologic Methods; Therapeutics; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Physical Therapy Modalities; Patient Care; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Behavioral Disciplines and Activities; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Mental Health Services; Epidemiologic Measurements; Physical Conditioning, Human; Exercise; Resistance Training; Nutrition Assessment; Counseling
• Other Study ID Numbers: OSU-19113; NCI-2020-13834 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No