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

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ClinicalTrials.gov Identifier: NCT02485470
Recruitment Status : Recruiting
First Posted : June 30, 2015
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center

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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Other: MPACT Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Benefits of MPACT in Locally Advanced Head and Neck Cancer Patients Undergoing Chemoradiotherapy
Study Start Date : February 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: MPACT
Maintaining Physical Activity during Cancer Treatment

No Intervention: Usual Care



Primary Outcome Measures :
  1. Mean change in 6 minute walk distance (6MWD) [ Time Frame: 1 Year ]
    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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485470


Contacts
Contact: Shruti Jolly, M.D. 734-936-4302 shrutij@umich.edu

Locations
United States, Michigan
The University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Shruti Jolly, M.D.    734-936-4302    shrutij@umich.edu   
Principal Investigator: Shruti Jolly, MD         
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Shruti Jolly, M.D. University of Michigan Cancer Center

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT02485470     History of Changes
Other Study ID Numbers: UMCC 2015.073
HUM00100889 ( Other Identifier: University of Michigan )
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms