Exercise Post-Diagnosis of Breast Cancer

Overview

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.

Full Title of Study: “A Pilot Study: The Effect of Longitudinal Exercise Programming in Breast Cancer Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 1, 2026

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.

Interventions

  • Other: Exercise
    • First Intervention 12-week exercise program, 3 days/week, 90min exercise sessions at the Rehabilitation Hospital of the Pacific. Private or semi-private (1:1 or 2:1 ratio participant to instructor) sessions, led by Kinesiology students Second Intervention- 12-week exercise program, 2 days/week, 90min exercise sessions at the Rehabilitation Hospital of the Pacific. Group Fitness Classes

Arms, Groups and Cohorts

  • Active Comparator: Group 1 – Agree to Exercise Program
    • 12-week exercise program
  • No Intervention: Group 2 – Declines Exercise Program
    • Same biometric and biomarker assessment at as Group 1 (at baseline, after 12 weeks and annually) however they will not participate in the exercise sessions

Clinical Trial Outcome Measures

Primary Measures

  • Fat mass
    • Time Frame: 1 day
    • Measure fat mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data
  • Isometric peak torque
    • Time Frame: 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
  • Lean mass
    • Time Frame: 1 day
    • Measure lean mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data
  • Bone mass
    • Time Frame: 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
    • Time Frame: 1 day
    • Manual physical anthropometry of waist and hip circumferences
  • Automatic 3D optical (3DO) scan measurement: girth measurement
    • Time Frame: 1 day
    • Automated 3DO measurements generate the following: girth in cm measurements across the whole body
  • Muscle Function
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 1 day
    • Automated 3DO measurements generate the following: length in cm measurements across the whole body
  • Automatic 3D optical (3DO) scan measurement: volume measurement
    • Time Frame: 1 day
    • Automated 3DO measurements generate the following: volume in cm measurements across the whole body
  • Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data
    • Time Frame: 1 day
    • Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data

Secondary Measures

  • Recurrence Free Survival
    • Time Frame: 5 years
    • obtained from last physician note
  • BIBCQ-Body Image After Breast Cancer questionnaire
    • Time Frame: 5 years
    • 45 items
  • BFI-Brief Fatigue Innovatory questionnaire
    • Time Frame: 5 years
    • 9 items
  • PHQ-9- Patient Health (Depression) questionnaire
    • Time Frame: 5 years
    • 9 items
  • FACT-G-Functional Assessment of Cancer Therapy-General (Comorbidities)questionnaire
    • Time Frame: 5 years
    • 27 items
  • Diet History Questionnaire II
    • Time Frame: 5 years
    • Self-reported energy intake, measured as kcal/day
  • Biomarkers
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Hawaii
  • Collaborator
    • Rehabilitation Hospital of the Pacific
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jami Fukui, MD, Principal Investigator, University of Hawaii Cancer Research Center
  • Overall Contact(s)
    • Jami Fukui, MD, 808-441-8199, JFukui@cc.hawaii.edu

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