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Completed

NCT Number: NCT04013568

Exercise Post-Diagnosis of Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

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

Primary outcomes

  1. Fat mass

    Time frame: 1 day

    Measure fat mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data

  2. 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

  3. Lean mass

    Time frame: 1 day

    Measure lean mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data

  4. Bone mass

    Time frame: 1 day

    Measure bone mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data

  5. Waist to Hip ratio (WHR) from manual tape measurement

    Time frame: 1 day

    Manual physical anthropometry of waist and hip circumferences

  6. 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

  7. 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

  8. Percent fat

    Time frame: 1 day

    Percent fat (arms, legs, trunk and total) using Dual energy X-ray absorptiometry (DXA) data

  9. 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

  10. 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

  11. 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 outcomes

  1. Recurrence Free Survival

    Time frame: 5 years

    obtained from last physician note

  2. BIBCQ-Body Image After Breast Cancer questionnaire

    Time frame: 5 years

    45 items

  3. BFI-Brief Fatigue Innovatory questionnaire

    Time frame: 5 years

    9 items

  4. PHQ-9- Patient Health (Depression) questionnaire

    Time frame: 5 years

    9 items

  5. FACT-G-Functional Assessment of Cancer Therapy-General (Comorbidities)questionnaire

    Time frame: 5 years

    27 items

  6. Diet History Questionnaire II

    Time frame: 5 years

    Self-reported energy intake, measured as kcal/day

  7. 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

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

  • Rehabilitation Hospital of the Pacific

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2019
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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