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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-19

Study Completion Date

2023-02-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Locally Advanced Head and Neck Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (resistance exercise, counseling)

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.

Group Type EXPERIMENTAL

Counseling

Intervention Type OTHER

Receive group-based behavioral counseling

Dietary Counseling and Surveillance

Intervention Type BEHAVIORAL

Receive dietary counseling

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Resistance Training

Intervention Type OTHER

Undergo personalized resistance exercises

Interventions

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Counseling

Receive group-based behavioral counseling

Intervention Type OTHER

Dietary Counseling and Surveillance

Receive dietary counseling

Intervention Type BEHAVIORAL

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Resistance Training

Undergo personalized resistance exercises

Intervention Type OTHER

Other Intervention Names

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Counseling Intervention Quality of Life Assessment Strength Training

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No