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

Locally Advanced Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04733495
• Other study ID #: OSU-19113
• Secondary ID: NCI-2020-13834
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Locally Advanced Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Other:
• Counseling
Receive group-based behavioral counseling

Behavioral:
• Dietary Counseling and Surveillance
Receive dietary counseling

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies
• Resistance Training
Undergo personalized resistance exercises

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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

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