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

NCT04733495 | Completed DMC

• 2 other identifiers: OSU-19113NCI-2020-13834
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (17)

• 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

Study Arms (1)

Supportive care (resistance exercise, counseling)

EXPERIMENTAL

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: Counseling; Behavioral: Dietary Counseling and Surveillance; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Resistance Training

Interventions

Counseling OTHER

Receive group-based behavioral counseling

Also known as: Counseling Intervention

Supportive care (resistance exercise, counseling)

Dietary Counseling and Surveillance BEHAVIORAL

Receive dietary counseling

Supportive care (resistance exercise, counseling)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (resistance exercise, counseling)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (resistance exercise, counseling)

Resistance Training OTHER

Undergo personalized resistance exercises

Also known as: Strength Training

Supportive care (resistance exercise, counseling)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Interventions

Counseling; Nutrition Assessment; Resistance Training

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dukagjin Blakaj, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: February 2, 2021
• Study Start: April 19, 2021
• Primary Completion: May 22, 2022
• Study Completion: February 20, 2023
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)