Exercise Post-Diagnosis of Breast Cancer

A Pilot Study: The Effect of Longitudinal Exercise Programming in Breast Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Exercise

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • University of Hawaii Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 - Agree to Exercise Program; 12-week exercise program	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
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Hawaii
• Collaborators: Rehabilitation Hospital of the Pacific
• Investigators: Principal Investigator: Jami Fukui, MD, University of Hawaii Cancer Research Center

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2019
• Primary Completion (Actual): March 6, 2026
• Study Completion (Actual): March 6, 2026

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: Fukui-2019-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No