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

NCT02485470 | Terminated Phase 2 DMC

• 2 other identifiers: UMCC 2015.073HUM00100889
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mean change in 6 minute walk distance (6MWD)

  6 MWD will be assessed at baseline, at weeks 4, 7, 11, and 14 and at 6 months and 1 year. The change from baseline will be calculated for each participant and longitudinal mixed models will be used to characterize mean outcomes over time for each intervention group.

  1 Year

Study Arms (2)

MPACT

EXPERIMENTAL

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.

Other: MPACT

Usual Care

NO INTERVENTION

Interventions

MPACT OTHER

Maintaining Physical Activity during Cancer Treatment

MPACT

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Michelle Mierzwa, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: June 30, 2015
• Study Start: February 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 9, 2019

Record last verified: 2019-10

Locations

US (1)