Locally Advanced Head and Neck Squamous Cell CarcinomaNCT04733495
Group-Mediated Cognitive Behavioral Resistance Exercise Intervention in Head and Neck Cancer Patients Undergoing Chemoradiation Treatment
A study testing Counseling, Dietary Counseling and Surveillance and Quality-of-Life Assessment in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Counseling, Dietary Counseling and Surveillance and Quality-of-Life Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2021to 20 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Counseling, Dietary Counseling and Surveillance, Quality-of-Life Assessment, Questionnaire Administration, Resistance Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingOther
Also called Counseling Intervention
Receive group-based behavioral counseling
Dietary Counseling and SurveillanceBehavioural
Receive dietary counseling
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Resistance TrainingOther
Also called Strength Training
Undergo personalized resistance exercises
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Counseling; Behavioral: Dietary Counseling and Surveillance; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rates
Number of patients agreed to participate by signing the informed consent
Measured: 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..
Measured: 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..
Measured: At 6-month
Incidence of adverse events
Monitored by direct observation and or patient reporting of signs and symptoms using NCI CTCAE version 5
Measured: At 3-month
Incidence of adverse events
Monitored by direct observation and or patient reporting of signs and symptoms using NCI CTCAE version 5
Measured: At 6-month
Retention rates
Rates will be calculated prospectively throughout the trial
Measured: At 3-month
Retention rates
Rates will be calculated prospectively throughout the trial
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start19 Apr 2021
- Primary completion22 May 2022
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dukagjin Blakaj, Ohio State University Comprehensive Cancer Center
- Investigators
- Dukagjin Blakaj, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733495
- Sponsor's protocol ID
- OSU-19113
- Other IDs
- NCI-2020-13834
- Status last verified
- Jun 2026
- First submitted
- 6 Jan 2021
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Group-Mediated Cognitive Behavioral Resistance Exercise Intervention in Head and Neck Cancer Patients Undergoing Chemoradiation Treatment
- ClinicalTrials.gov ID
- NCT04733495
- Acronym / sponsor ID
- OSU-19113
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 22 May 2022 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (resistance exercise, counseling) | Experimental | Other: Counseling, Behavioral: Dietary Counseling and Surveillance, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Resistance TrainingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounselingAlso: Counseling InterventionReceive group-based behavioral counseling | Other | Supportive care (resistance exercise, counseling) |
| Dietary Counseling and SurveillanceReceive dietary counseling | Behavioural | Supportive care (resistance exercise, counseling) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive care (resistance exercise, counseling) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (resistance exercise, counseling) |
| Resistance TrainingAlso: Strength TrainingUndergo personalized resistance exercises | Other | Supportive care (resistance exercise, counseling) |
Primary outcome
Recruitment rates
Time frame: At baseline
Number of patients agreed to participate by signing the informed consent
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..
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..
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
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
Retention rates
Time frame: At 3-month
Rates will be calculated prospectively throughout the trial
Retention rates
Time frame: At 6-month
Rates will be calculated prospectively throughout the trial
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dukagjin Blakaj, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling, Dietary Counseling and Surveillance and Quality-of-Life Assessment in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates (time frame: At baseline). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.