Exercise Post-Diagnosis of Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04013568
• Other study ID #: Fukui-2019-1
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2019
• Est. completion date: September 1, 2026

Study information

• Verified date: October 2023
• Source: University of Hawaii
• Contact: Jami Fukui, MD
• Phone: 808-441-8199
• Email: JFukui[@]cc.hawaii.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Hawaii Cancer Center	Honolulu	Hawaii

Sponsors (2)

Lead Sponsor	Collaborator
University of Hawaii	Rehabilitation Hospital of the Pacific

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat mass	Measure fat mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data	1 day
Primary	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
Primary	Lean mass	Measure lean mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data	1 day
Primary	Bone mass	Measure bone mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data	1 day
Primary	Waist to Hip ratio (WHR) from manual tape measurement	Manual physical anthropometry of waist and hip circumferences	1 day
Primary	Automatic 3D optical (3DO) scan measurement: girth measurement	Automated 3DO measurements generate the following: girth in cm measurements across the whole body	1 day
Primary	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
Primary	Percent fat	Percent fat (arms, legs, trunk and total) using Dual energy X-ray absorptiometry (DXA) data	1 day
Primary	Automatic 3D optical (3DO) scan measurement: length measurement	Automated 3DO measurements generate the following: length in cm measurements across the whole body	1 day
Primary	Automatic 3D optical (3DO) scan measurement: volume measurement	Automated 3DO measurements generate the following: volume in cm measurements across the whole body	1 day
Primary	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	Recurrence Free Survival	obtained from last physician note	5 years
Secondary	BIBCQ-Body Image After Breast Cancer questionnaire	45 items	5 years
Secondary	BFI-Brief Fatigue Innovatory questionnaire	9 items	5 years
Secondary	PHQ-9- Patient Health (Depression) questionnaire	9 items	5 years
Secondary	FACT-G-Functional Assessment of Cancer Therapy-General (Comorbidities)questionnaire	27 items	5 years
Secondary	Diet History Questionnaire II	Self-reported energy intake, measured as kcal/day	5 years
Secondary	Biomarkers	Adipokines: leptin, HMW-high molecular weight adiponectin, PAI1-plasminogen activator inhibitor; Cytokines & Inflammation: TNF-tumor necrosis factor a, IL-interleukin 1ß, 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