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

The Ohio State University

Status: Completed

Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04733495

OSU-19113

NCI-2020-13834 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Supportive care (resistance exercise, counseling)

Experimental group

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.

Treatment:

Behavioral: Dietary Counseling and Surveillance

Other: Counseling

Other: Resistance Training

Other: Questionnaire Administration

Other: Quality-of-Life Assessment