Benefits of MPACT in Locally Advanced Head and Neck Cancer Patients Undergoing Chemoradiotherapy

NCT ID: NCT02485470

Last Updated: 2019-10-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-10-31

Brief Summary

The goal of this study is to test, in a randomized controlled trial among head and neck cancer patients, the short and longer term effects of the MPACT (Maintaining Physical Activity during Cancer Treatment) program (infused with motivational interviewing and self-determination theory-based strategies) initiated at the time of concurrent chemotherapy with radiation (CCRT), on key outcomes such as functional mobility and quality of life, and ultimately physical activity. The central hypotheses is that in head and neck cancer patients undergoing CCRT, the MPACT program, as compared to usual care controls, will result in less acute decline, faster recovery, and better maintenance of these key outcomes.

Conditions

Head and Neck Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

MPACT

A 7-week (7 weeks x 3 sessions per week), on site, functional resistance training (FRT) as well as a walking program concurrent with CCRT will be followed by a 7-week post-CCRT home program. The protocol follows American College of Sports Medicine (ACSM) prescription guidelines for cancer patients.

Group Type: EXPERIMENTAL

MPACT

Intervention Type: OTHER

Maintaining Physical Activity during Cancer Treatment

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MPACT

Maintaining Physical Activity during Cancer Treatment

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients greater than or equal to 40 years old with AJCC (American Joint Committee on Cancer) stage II-IV head and neck squamous cell carcinoma who are beginning first-line non-surgical treatment with concurrent chemoradiotherapy (CCRT) and who are capable of understanding and adhering to the protocol requirements
• Patients must be willing to comply with the study procedures and visits.

Exclusion Criteria

• Active or symptomatic cardiopulmonary disease
• Substantial dementia
• Acute medical conditions, such as acute flare-up of joint condition or infection
• Participants must not be actively receiving physical therapy in a relevant area, at the time of enrollment, or participating in intensive (30 min per day) aerobic program three times per week.
• Patients are actively being treated for another cancer at the time of enrollment
• Active or unstable metabolic conditions such as brittle diabetes or severe anemia
• Alcohol intake less than 3 ounces per day
• Hemiplegia or lower limb amputation
• Significant orthopedic or musculoskeletal condition that does not allow weight bearing
• Unable to maintain safe stance and walk, either with or without an assistive device

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Mierzwa, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00100889

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2015.073

Identifier Type: -

Identifier Source: org_study_id