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Completed

NCT Number: NCT04733495

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.

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Key information

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling

Other

Receive group-based behavioral counseling

Other names: Counseling Intervention

Dietary Counseling and Surveillance

Behavioral

Receive dietary counseling

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Resistance training

Other

Undergo personalized resistance exercises

Other names: Strength Training

Primary outcomes

  1. Recruitment rates

    Time frame: At baseline

    Number of patients agreed to participate by signing the informed consent

  2. Adherence of Intervention

    Time frame: At 3-month

    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..

  3. Adherence of Intervention

    Time frame: At 6-month

    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..

  4. Incidence of adverse events

    Time frame: At 3-month

    Monitored by direct observation and or patient reporting of signs and symptoms using NCI CTCAE version 5

  5. Incidence of adverse events

    Time frame: At 6-month

    Monitored by direct observation and or patient reporting of signs and symptoms using NCI CTCAE version 5

  6. Retention rates

    Time frame: At 3-month

    Rates will be calculated prospectively throughout the trial

  7. Retention rates

    Time frame: At 6-month

    Rates will be calculated prospectively throughout the trial

  8. Functional Battery

    Time frame: At 3-month

    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.

  9. Functional Battery

    Time frame: At 6-month

    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.

  10. Patient Reported Outcomes (Quality of Life/Fatigue/Physical Function)

    Time frame: At 3-month

    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).

  11. Patient Reported Outcomes (Quality of Life/Fatigue/Physical Function)

    Time frame: At 6-month

    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).

  12. Muscular strength

    Time frame: At 3-month

    Muscular strength will be assessed using standardized one-repetition maximum testing protocols for the chest press and leg extension exercises.

  13. Muscular strength

    Time frame: At 6-month

    Muscular strength will be assessed using standardized one-repetition maximum testing protocols for the chest press and leg extension exercises.

  14. Anthropometric measurements

    Time frame: At 3-month

    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.

  15. Anthropometric measurements

    Time frame: At 6-month

    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.

  16. Body composition

    Time frame: At 3-month

    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.

  17. Body composition

    Time frame: At 6-month

    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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 2, 2021
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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