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

Head and Neck Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02485470
• Other study ID #: UMCC 2015.073
• Secondary ID: HUM00100889
• Status: Terminated
• Phase: Phase 2
• Start date: February 2016
• Est. completion date: October 2018

Study information

• Verified date: October 2019
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Other:
• MPACT
Maintaining Physical Activity during Cancer Treatment

Locations

Country	Name	City	State
United States	The University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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