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

Primary Purpose

Locally Advanced Head and Neck Squamous Cell Carcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counseling
Dietary Counseling and Surveillance
Quality-of-Life Assessment
Questionnaire Administration
Resistance Training
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Locally Advanced Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (resistance exercise, counseling)

Arm Description

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.

Outcomes

Primary Outcome Measures

Recruitment rates
Number of patients agreed to participate by signing the informed consent
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..
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..
Incidence of adverse events
Monitored by direct observation and or patient reporting of signs and symptoms using NCI CTCAE version 5
Incidence of adverse events
Monitored by direct observation and or patient reporting of signs and symptoms using NCI CTCAE version 5
Retention rates
Rates will be calculated prospectively throughout the trial
Retention rates
Rates will be calculated prospectively throughout the trial
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.
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.
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).
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).
Muscular strength
Muscular strength will be assessed using standardized one-repetition maximum testing protocols for the chest press and leg extension exercises.
Muscular strength
Muscular strength will be assessed using standardized one-repetition maximum testing protocols for the chest press and leg extension exercises.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 6, 2021
Last Updated
May 17, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04733495
Brief Title
Group-Mediated Cognitive Behavioral Resistance Exercise Intervention in Head and Neck Cancer Patients Undergoing Chemoradiation Treatment
Official Title
A Group-Mediated Cognitive Behavioral Resistance Exercise Intervention in Head and Neck Cancer Patients Undergoing Chemoradiation Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
February 20, 2023 (Actual)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Head and Neck Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (resistance exercise, counseling)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Counseling
Other Intervention Name(s)
Counseling Intervention
Intervention Description
Receive group-based behavioral counseling
Intervention Type
Behavioral
Intervention Name(s)
Dietary Counseling and Surveillance
Intervention Description
Receive dietary counseling
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Resistance Training
Other Intervention Name(s)
Strength Training
Intervention Description
Undergo personalized resistance exercises
Primary Outcome Measure Information:
Title
Recruitment rates
Description
Number of patients agreed to participate by signing the informed consent
Time Frame
At baseline
Title
Adherence of Intervention
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..
Time Frame
At 3-month
Title
Adherence of Intervention
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..
Time Frame
At 6-month
Title
Incidence of adverse events
Description
Monitored by direct observation and or patient reporting of signs and symptoms using NCI CTCAE version 5
Time Frame
At 3-month
Title
Incidence of adverse events
Description
Monitored by direct observation and or patient reporting of signs and symptoms using NCI CTCAE version 5
Time Frame
At 6-month
Title
Retention rates
Description
Rates will be calculated prospectively throughout the trial
Time Frame
At 3-month
Title
Retention rates
Description
Rates will be calculated prospectively throughout the trial
Time Frame
At 6-month
Title
Functional Battery
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.
Time Frame
At 3-month
Title
Functional Battery
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.
Time Frame
At 6-month
Title
Patient Reported Outcomes (Quality of Life/Fatigue/Physical Function)
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).
Time Frame
At 3-month
Title
Patient Reported Outcomes (Quality of Life/Fatigue/Physical Function)
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).
Time Frame
At 6-month
Title
Muscular strength
Description
Muscular strength will be assessed using standardized one-repetition maximum testing protocols for the chest press and leg extension exercises.
Time Frame
At 3-month
Title
Muscular strength
Description
Muscular strength will be assessed using standardized one-repetition maximum testing protocols for the chest press and leg extension exercises.
Time Frame
At 6-month
Title
Anthropometric measurements
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.
Time Frame
At 3-month
Title
Anthropometric measurements
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.
Time Frame
At 6-month
Title
Body composition
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.
Time Frame
At 3-month
Title
Body composition
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.
Time Frame
At 6-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dukagjin Blakaj, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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