Clinical trial NCT04013568: Exercise Post-Diagnosis of Breast Cancer
Official title: A Pilot Study: The Effect of Longitudinal Exercise Programming in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: Rehabilitation Hospital of the Pacific
First posted: 2019-07-09
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants choose the initial intervention (12-week exercise program (Group1) vs monitoring (Group2)).
Primary purpose: TREATMENT

Brief summary: The investigators are doing this study to determine if there are body composition changes after a 12-week exercise program in breast cancer patients and determine what factors contribute to sustained physical activity after the 12-week exercise program intervention.

Detailed description: The study is enrolling breast cancer patients up to 2 years after their diagnosis in a 12-week exercise program. The participants will either participate in: Group 1-participating in an exercise program with biometric evaluations or Group 2-biometric evaluations but not participating in the exercise program. At the end of the 12-week exercise program, participants in Group 1 will be randomized to either: a) continuing with exercise group classes or b) continuing with exercise individual classes. Both Group 1a and 1b participants will be followed for the remainder of the year and be evaluated for continued physical activity. All Group study participants' biometrics will be assessed at baseline and at the end of 12-weeks, with continued annual medical review follow-up for a total of 5 years.

Eligibility criteria: Inclusion Criteria:

* New diagnosis of breast cancer (within the past 2 years, any subtype, stage I-III)
* Can be undergoing neo/adjuvant treatment (surgery, chemotherapy, radiation or endocrine therapy)
* Participant is willing and able to comply with the protocol for the duration of the study including undergoing scheduled exercise sessions, completing questionnaires and biometric/biomarker studies
* Participant must be able to lie flat on their back for up to 10 minutes
* Participant must be able to stand without aid for at least 2 minutes

Exclusion Criteria:

* Participant with breast cancer recurrence
* Metastatic breast cancer
* Uncontrolled psychiatric disorder that can affect self-assessment
* Pregnant patient
* Participants with any internal artifact (e.g. pacemakers, internal fixation, arthroplasty) or other physical impairment that would alter the body composition assessment

Primary outcomes:
measure: Fat mass
timeFrame: 1 day
measure: Isometric peak torque
timeFrame: 1 day
measure: Lean mass
timeFrame: 1 day
measure: Bone mass
timeFrame: 1 day
measure: Waist to Hip ratio (WHR) from manual tape measurement
timeFrame: 1 day
measure: Automatic 3D optical (3DO) scan measurement: girth measurement
timeFrame: 1 day
measure: Muscle Function
timeFrame: 1 day
measure: Percent fat
timeFrame: 1 day
measure: Automatic 3D optical (3DO) scan measurement: length measurement
timeFrame: 1 day
measure: Automatic 3D optical (3DO) scan measurement: volume measurement
timeFrame: 1 day
measure: Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data
timeFrame: 1 day
Secondary outcomes:
measure: Recurrence Free Survival
timeFrame: 5 years
measure: BIBCQ-Body Image After Breast Cancer questionnaire
timeFrame: 5 years
measure: BFI-Brief Fatigue Innovatory questionnaire
timeFrame: 5 years
measure: PHQ-9- Patient Health (Depression) questionnaire
timeFrame: 5 years
measure: FACT-G-Functional Assessment of Cancer Therapy-General (Comorbidities)questionnaire
timeFrame: 5 years
measure: Diet History Questionnaire II
timeFrame: 5 years
measure: Biomarkers
timeFrame: 5 years
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: University of Hawaii Cancer Center
state: Hawaii
Study officials:
affiliation: University of Hawaii Cancer Research Center
name: Jami Fukui, MD
role: PRINCIPAL_INVESTIGATOR
References: