Clinical trial NCT04733495: 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
Overall status: COMPLETED
Phase: NA
Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Recruitment rates
timeFrame: At baseline
measure: Adherence of Intervention
timeFrame: At 3-month
measure: Adherence of Intervention
timeFrame: At 6-month
measure: Incidence of adverse events
timeFrame: At 3-month
measure: Incidence of adverse events
timeFrame: At 6-month
measure: Retention rates
timeFrame: At 3-month
measure: Retention rates
timeFrame: At 6-month
measure: Functional Battery
timeFrame: At 3-month
measure: Functional Battery
timeFrame: At 6-month
measure: Patient Reported Outcomes (Quality of Life/Fatigue/Physical Function)
timeFrame: At 3-month
measure: Patient Reported Outcomes (Quality of Life/Fatigue/Physical Function)
timeFrame: At 6-month
measure: Muscular strength
timeFrame: At 3-month
measure: Muscular strength
timeFrame: At 6-month
measure: Anthropometric measurements
timeFrame: At 3-month
measure: Anthropometric measurements
timeFrame: At 6-month
measure: Body composition
timeFrame: At 3-month
measure: Body composition
timeFrame: At 6-month
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Dukagjin Blakaj, MD
role: PRINCIPAL_INVESTIGATOR
References: