Exercise Post-Diagnosis of Breast Cancer

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Other: Exercise

• Registration Number: NCT04013568
• Lead Sponsor: University of Hawaii

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.

Study Timeline

• Study First Submitted: 2019-06-14
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-09
• Study Start: 2019-08-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-10
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 - Agree to Exercise Program	Exercise	12-week exercise program

Primary Outcome Measures

Name	Time	Method
Lean mass	1 day	Measure lean mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data
Bone mass	1 day	Measure bone mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data
Waist to Hip ratio (WHR) from manual tape measurement	1 day	Manual physical anthropometry of waist and hip circumferences
Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data	1 day	Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data
Muscle Function	1 day	Measure the peak torque value generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device
Automatic 3D optical (3DO) scan measurement: volume measurement	1 day	Automated 3DO measurements generate the following: volume in cm measurements across the whole body
Automatic 3D optical (3DO) scan measurement: girth measurement	1 day	Automated 3DO measurements generate the following: girth in cm measurements across the whole body
Fat mass	1 day	Measure fat mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data
Isometric peak torque	1 day	Measure the peak torque value generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device
Percent fat	1 day	Percent fat (arms, legs, trunk and total) using Dual energy X-ray absorptiometry (DXA) data
Automatic 3D optical (3DO) scan measurement: length measurement	1 day	Automated 3DO measurements generate the following: length in cm measurements across the whole body

Secondary Outcome Measures

Name	Time	Method
FACT-G-Functional Assessment of Cancer Therapy-General (Comorbidities)questionnaire	5 years	27 items
Recurrence Free Survival	5 years	obtained from last physician note
BIBCQ-Body Image After Breast Cancer questionnaire	5 years	45 items
BFI-Brief Fatigue Innovatory questionnaire	5 years	9 items
PHQ-9- Patient Health (Depression) questionnaire	5 years	9 items
Diet History Questionnaire II	5 years	Self-reported energy intake, measured as kcal/day
Biomarkers	5 years	Adipokines: leptin, HMW-high molecular weight adiponectin, PAI1-plasminogen activator inhibitor; Cytokines \& Inflammation: TNF-tumor necrosis factor α, IL-interleukin 1β, IL2, IL4, IL5, IL6, IL8, IL10, interferon, CRP-C reactive protein, uric acid, cortisol; Insulin Resistance \& IGFs: glucose, insulin, Hb-hemoglobin A1C, IGF-insulin growth factor 1, IGFBP-insulin like growth factor binding protein 1-3; Sex Steroid Hormones: total estradiol \& estrone, total testosterone, SHBG-sex hormone-binding globulin (for free estradiol and free testosterone will be derived); Lipid Profile \& Lipid-soluble Micronutrients: TG-triglycerides , total cholesterol, HDLC-high density lipoprotein cholesterol , free fatty acids, lycopene, 25OH-vitamin D3, alpha-tocopherol; Liver Enzymes: ALT-alanine aminotransferase; Neuropeptides \& Gut Hormones: ghrelin; MOTS-mitochondrial derived peptide-c

Trial Locations

Locations (1)

University of Hawaii Cancer Center; 🇺🇸 Honolulu, Hawaii, United States