search
Back to results

Exercise Post-Diagnosis of Breast Cancer

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Hawaii
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Hawaii Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group 1 - Agree to Exercise Program

Group 2 - Declines Exercise Program

Arm Description

12-week 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 14, 2019
Last Updated
October 18, 2023
Sponsor
University of Hawaii
Collaborators
Rehabilitation Hospital of the Pacific
search

1. Study Identification

Unique Protocol Identification Number
NCT04013568
Brief Title
Exercise Post-Diagnosis of Breast Cancer
Official Title
A Pilot Study: The Effect of Longitudinal Exercise Programming in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2019 (Actual)
Primary Completion Date
September 1, 2026 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hawaii
Collaborators
Rehabilitation Hospital of the Pacific

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants choose the initial intervention (12-week exercise program (Group1) vs monitoring (Group2)).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - Agree to Exercise Program
Arm Type
Active Comparator
Arm Description
12-week exercise program
Arm Title
Group 2 - Declines Exercise Program
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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 Outcome Measure Information:
Title
Fat mass
Description
Measure fat mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data
Time Frame
1 day
Title
Isometric peak torque
Description
Measure the peak torque value generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device
Time Frame
1 day
Title
Lean mass
Description
Measure lean mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data
Time Frame
1 day
Title
Bone mass
Description
Measure bone mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data
Time Frame
1 day
Title
Waist to Hip ratio (WHR) from manual tape measurement
Description
Manual physical anthropometry of waist and hip circumferences
Time Frame
1 day
Title
Automatic 3D optical (3DO) scan measurement: girth measurement
Description
Automated 3DO measurements generate the following: girth in cm measurements across the whole body
Time Frame
1 day
Title
Muscle Function
Description
Measure the peak torque value generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device
Time Frame
1 day
Title
Percent fat
Description
Percent fat (arms, legs, trunk and total) using Dual energy X-ray absorptiometry (DXA) data
Time Frame
1 day
Title
Automatic 3D optical (3DO) scan measurement: length measurement
Description
Automated 3DO measurements generate the following: length in cm measurements across the whole body
Time Frame
1 day
Title
Automatic 3D optical (3DO) scan measurement: volume measurement
Description
Automated 3DO measurements generate the following: volume in cm measurements across the whole body
Time Frame
1 day
Title
Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data
Description
Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Recurrence Free Survival
Description
obtained from last physician note
Time Frame
5 years
Title
BIBCQ-Body Image After Breast Cancer questionnaire
Description
45 items
Time Frame
5 years
Title
BFI-Brief Fatigue Innovatory questionnaire
Description
9 items
Time Frame
5 years
Title
PHQ-9- Patient Health (Depression) questionnaire
Description
9 items
Time Frame
5 years
Title
FACT-G-Functional Assessment of Cancer Therapy-General (Comorbidities)questionnaire
Description
27 items
Time Frame
5 years
Title
Diet History Questionnaire II
Description
Self-reported energy intake, measured as kcal/day
Time Frame
5 years
Title
Biomarkers
Description
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
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jami Fukui, MD
Phone
808-441-8199
Email
JFukui@cc.hawaii.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Drucker, MS
Phone
808-564-3989
Email
bcexercise@cc.hawaii.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jami Fukui, MD
Organizational Affiliation
University of Hawaii Cancer Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hawaii Cancer Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jami Fukui, MD
Phone
808-441-8199

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exercise Post-Diagnosis of Breast Cancer

We'll reach out to this number within 24 hrs