Breast CancerNCT04365569
Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program
A study testing Nutrition and physical activity counseling program in people with Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
More than 65% of breast cancer survivors are overweight and less than one-third participate in recommended levels of physical exercise. Obese breast cancer survivors have been found to have greater than a two-fold increase in mortality compared to women with normal body mass index (BMI). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Nutrition and physical activity counseling program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2021to 16 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer diagnosis (stage 0-III)
- Body mass index of 25mg/k2 or greater
- Actively being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center
- Able and willing to participate in nutrition counseling at Maroone Cancer Center
- Able (cleared by participant's primary oncologist) and willing to perform cardiopulmonary exercise testing
- Participants must have the ability to understand and the willingness to sign a written informed consent document
- Performance status 0 or 1 as per ECOG scale [see Appendix IV]
Who cannot join
- Body mass index below 25kg/m2
- No prior history of breast cancer
- History of metastatic disease
- Not being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center
- Unable or unwilling to participate in nutrition counseling at Maroone Cancer Center
- Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Participants actively undergoing chemotherapy, immunotherapy or radiation treatment. However, participants currently taking hormonal therapy, such as selective estrogen receptor modulators (SERMS), or aromatase inhibitors, may be included in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center
Weston, Florida, 33331
About this study
Official title: Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program on Body Weight, Composition, Cardiovascular Function and Quality of Life in Breast Cancer Survivors
More than 65% of breast cancer survivors are overweight and less than one-third participate in recommended levels of physical exercise. Obese breast cancer survivors have been found to have greater than a two-fold increase in mortality compared to women with normal body mass index (BMI). The current standard for weight loss interventions involves in-person counseling. However, this incurs costs related to travel for counseling sessions, potentially limiting program participation, compliance and sustainability.This is a pilot study of an individualized in-person and telephone-based nutrition and exercise counseling program.
- Conditions
- Breast Cancer
- Being tested
- Nutrition and physical activity counseling program
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and physical activity counseling programBehavioural
6-month interventional, counseling program based on nutrition and physical activity consisting of:
- Nutritional counseling by a Registered Dietitian (RD) 2) Implementation of an adequate physical activity program
| Study group | Role | What they receive |
|---|---|---|
| Individualized, nutrition and physical activity intervention | Experimental | Initial in-person consult with a registered dietitian, with further in-person follow-ups and monthly telephone consults Receives: Behavioral: Nutrition and physical activity counseling program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants achieving 10% weight loss
Efficacy of intervention as assessed by percent of participants achieving 10% weight loss
Measured: At baseline
Percent of participants achieving 10% weight loss
Efficacy of intervention as assessed by percent of participants achieving 10% weight loss
Measured: At 3 months
Percent of participants achieving 10% weight loss
Efficacy of intervention as assessed by percent of participants achieving 10% weight loss
Measured: At 6 months
Compliance to the recommended dietary pattern
Assess compliance to the recommended dietary pattern, diet quality scores will be calculated by the RD after monthly telephone consults or in-person at 3 months and 6 months into the intervention. Each of the 3 elements will be scored from 0-3, resulting in a total score range from 0-9
Measured: At 3 months
Compliance to physical activity goal
Percent of participants complying with proposed activity goal of 150 minutes of moderate intensity physical activity or 75 minutes of vigerous intensity physical activity (or a combination of both) per week over six months
Measured: At 6 months
Secondary outcomes (20)
Body fat percentage
Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis
Measured: Baseline
Body fat percentage
Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis
Measured: 3 months
Body fat percentage
Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis
Measured: 6 months
Glycemic control as measured by HbA1c
Glycemic control as measured by HbA1c
Measured: At 3 months
Glycemic control as measured by HbA1c
Glycemic control as measured by HbA1c
Measured: At 6 months
Cholesterol
Effect of the intervention on lipid profile as measured by high density cholesterol levels
Measured: At 3 months
Cholesterol
Effect of the intervention on lipid profile as measured by high density cholesterol levels
Measured: At 6 months
Low density lipoprotein
Effect of the intervention on lipid profile as measured by low density lipoprotein levels
Measured: At 3 months
Low density lipoprotein
Effect of the intervention on lipid profile as measured by low density lipoprotein levels
Measured: At 6 months
high density lipoprotein
Effect of the intervention on lipid profile as measured by high density lipoprotein levels
Measured: At 3 months
high density lipoprotein
Effect of the intervention on lipid profile as measured by high density lipoprotein levels
Measured: At 6 months
Triglycerides
Effect of the intervention on lipid profile as measured by triglyceride levels
Measured: At 3 months
Triglycerides
Effect of the intervention on lipid profile as measured by triglyceride levels
Measured: At 6 months
Serum vitamin D
Effect of the intervention on serum vitamin D
Measured: At 3 months
Serum vitamin D
Effect of the intervention on serum vitamin D
Measured: At 6 months
Serum C-reactive protein (CRP)
Effect of the intervention on CRP
Measured: At 3 months
Serum C-reactive protein (CRP)
Effect of the intervention on CRP
Measured: At 6 months
Maximum oxygen uptake as measured by VO2 max
Maximum oxygen uptake as measured by VO2 max
Measured: Baseline
Maximum oxygen uptake as measured by VO2 max
Maximum oxygen uptake as measured by VO2 max
Measured: At 3 months
Maximum oxygen uptake as measured by VO2 max
Maximum oxygen uptake as measured by VO2 max
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start6 Jan 2021
- Primary completion16 May 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Stone, MD, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365569
- Sponsor's protocol ID
- CASE11119
- Status last verified
- Aug 2025
- First submitted
- 23 Apr 2020
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share IPD with other researchers within the same institution, but not outside the institution
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program on Body Weight, Composition, Cardiovascular Function and Quality of Life in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT04365569
- Acronym / sponsor ID
- CASE11119
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
More than 65% of breast cancer survivors are overweight and less than one-third participate in recommended levels of physical exercise. Obese breast cancer survivors have been found to have greater than a two-fold increase in mortality compared to women with normal body mass index (BMI). The current standard for weight loss interventions involves in-person counseling. However, this incurs costs related to travel for counseling sessions, potentially limiting program participation, compliance and sustainability.This is a pilot study of an individualized in-person and telephone-based nutrition and exercise counseling program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualized, nutrition and physical activity intervention | Experimental | Behavioral: Nutrition and physical activity counseling programInitial in-person consult with a registered dietitian, with further in-person follow-ups and monthly telephone consults |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Breast cancer diagnosis (stage 0-III)
- Body mass index of 25mg/k2 or greater
- Actively being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center
- Able and willing to participate in nutrition counseling at Maroone Cancer Center
- Able (cleared by participant's primary oncologist) and willing to perform cardiopulmonary exercise testing
Key exclusion criteria (7 listed)
- Body mass index below 25kg/m2
- No prior history of breast cancer
- History of metastatic disease
- Not being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center
- Unable or unwilling to participate in nutrition counseling at Maroone Cancer Center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition and physical activity counseling program6-month interventional, counseling program based on nutrition and physical activity consisting of: 1. Nutritional counseling by a Registered Dietitian (RD) 2) Implementation of an adequate physical activity program | Behavioural | Individualized, nutrition and physical activity intervention |
Primary outcome
Percent of participants achieving 10% weight loss
Time frame: At baseline
Efficacy of intervention as assessed by percent of participants achieving 10% weight loss
Percent of participants achieving 10% weight loss
Time frame: At 3 months
Efficacy of intervention as assessed by percent of participants achieving 10% weight loss
Percent of participants achieving 10% weight loss
Time frame: At 6 months
Efficacy of intervention as assessed by percent of participants achieving 10% weight loss
Compliance to the recommended dietary pattern
Time frame: At 3 months
Assess compliance to the recommended dietary pattern, diet quality scores will be calculated by the RD after monthly telephone consults or in-person at 3 months and 6 months into the intervention. Each of the 3 elements will be scored from 0-3, resulting in a total score range from 0-9
Compliance to physical activity goal
Time frame: At 6 months
Percent of participants complying with proposed activity goal of 150 minutes of moderate intensity physical activity or 75 minutes of vigerous intensity physical activity (or a combination of both) per week over six months
20 secondary outcomes
Body fat percentage
Time frame: Baseline
Body fat percentage
Time frame: 3 months
Body fat percentage
Time frame: 6 months
Glycemic control as measured by HbA1c
Time frame: At 3 months
Glycemic control as measured by HbA1c
Time frame: At 6 months
Cholesterol
Time frame: At 3 months
Cholesterol
Time frame: At 6 months
Low density lipoprotein
Time frame: At 3 months
Low density lipoprotein
Time frame: At 6 months
high density lipoprotein
Time frame: At 3 months
high density lipoprotein
Time frame: At 6 months
Triglycerides
Time frame: At 3 months
Triglycerides
Time frame: At 6 months
Serum vitamin D
Time frame: At 3 months
Serum vitamin D
Time frame: At 6 months
Serum C-reactive protein (CRP)
Time frame: At 3 months
Serum C-reactive protein (CRP)
Time frame: At 6 months
Maximum oxygen uptake as measured by VO2 max
Time frame: Baseline
Maximum oxygen uptake as measured by VO2 max
Time frame: At 3 months
Maximum oxygen uptake as measured by VO2 max
Time frame: At 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: Yes. Will share IPD with other researchers within the same institution, but not outside the institution
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Stone, MD principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and physical activity counseling program in people with Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants achieving 10% weight loss (time frame: At baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.