Breast Cancer FemaleNCT03270111
High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women
A study testing Supervised Exercise, Home-based Exercise and Reduced Energy Diet in people with Breast Cancer Female, run by Carol Fabian, MD at 1 site in United States.
Trial summary
The purpose of this second pilot study is to extend the feasibility demonstrated in NCT02963740 that the intervention achieves high levels of moderate to vigorous physical activity (MVI PA) and modulates risk biomarkers for breast cancer and cardiovascular disease in older, obese sedentary breast cancer survivors who… Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Supervised Exercise, Home-based Exercise and Reduced Energy Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2017to 24 Jul 2018
- 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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of breast cancer having completed any cytotoxic chemotherapy, radiation or surgery at least 3 months prior to study entry (Cohort A2) OR No prior diagnosis of breast cancer but at high risk for development of breast cancer and participating in HSC 4601 (Cohort B)
- Body Mass Index (BMI) >30 kg/m2. Women with a BMI > 45 kg/m2 must be age < 60 and ability to perform physical activity must be confirmed
- By self-assessment, currently performing 60 minutes or less of purposeful exercise per week but able to walk at least 30 minutes on a level surface
- Possession of smart phone capable of running MyFitnessPal and Garmin Connect apps and willing to have diet and exercise data accessed by study personnel
- Access to a personal computer
- Live in the greater Kansas City Metropolitan Area
Show all 10Show fewer
- Willing and able to perform moderate intensity exercise at least 5 days per week for 6 months. This consists of a supervised exercise intervention at one of the 15 YMCAs affiliated with our program for 2 days per week. Must be willing to perform unsupervised home exercise for the entire 6 months.
- Willing to participate in a weekly behavioral modification group phone call for first 3 months and every 2 weeks for the second 3 months
- Willing to participate in a controlled dietary intervention with portion controlled meals and partial meal replacements plus 35 servings of fruits and vegetables/week for 6 months and track food intake and exercise
- Blood tests (Cohort A2) must have been performed after completion of any breast cancer surgery, radiation therapy, or cytotoxic chemotherapy, with reasonably normal liver and renal function as well as a hemoglobin of 10 or higher and/or performed within a year of study entry
Who cannot join
- Use of metformin, insulin, steroids or prescription weight loss or anti-psychotic drugs within the prior 3 weeks
- Individuals with prior gastric bypass surgery or procedure that would impair absorption of nutrients
- Need for chronic immunosuppressive drugs
- Participation within the past 6 months on a structured weight loss program such as Weight Watchers®
- Physical impairments (bad hip, knees, feet, peripheral neuropathy) that would prohibit performing moderate intensity exercise at least 5 days per week.
- Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for participation in the trial such as recent cardiac event
- Currently receiving investigational agents in a clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: High Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women
The purpose of this second pilot study is to extend the feasibility demonstrated in NCT02963740 that the intervention achieves high levels of moderate to vigorous physical activity (MVI PA) and modulates risk biomarkers for breast cancer and cardiovascular disease in older, obese sedentary breast cancer survivors who are undergoing moderate calorie restriction.
Read the detailed description
All subjects participate in same intervention. Intervention consists of a 6-month structured weight loss program utilizing portion controlled meals and a prescribed level of graduated physical activity with an eventual goal of 200 minutes or more per week. The program will include twice weekly sessions with a trainer at a local YMCA, and weekly phone group sessions the first 3 months with transition to unsupervised exercise and less frequent group phone sessions the second 3 months.
- Conditions
- Breast Cancer Female
- Being tested
- Supervised Exercise, Home-based Exercise, Reduced Energy Diet, Group Phone Calls
- Keywords
- breast cancer survivor, weight loss program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised ExerciseBehavioural
Participants will take part in supervised exercise activities two times per week at a YMCA. Length of the activity will be increased during participation in study. Participants will start at 40 minutes per week and work their way up to 120 minutes per week.
Home-based ExerciseBehavioural
Aerobic exercise activities to be completed at home. Participants will be asked to start out doing 60 minutes at home and work up to 180 minutes of purposeful aerobic home exercise per week.
Reduced Energy DietBehavioural
Diet is a nutritionally balanced, reduced energy diet recommended by the Academy of Nutrition and Dietetics.
Group Phone CallsBehavioural
Sessions are weekly months 1-3 and every other week months 4-6. The calls will discuss lifestyle changes specific to participants and cover the effects of diet, physical activity, and weight on breast cancer risk, as well as body image and emotional eating.
| Study group | Role | What they receive |
|---|---|---|
| A2: Breast Cancer Survivor | Experimental | Participants will include breast cancer survivors who take part in a weight loss intervention program. The intervention is the same for all participants. Receives: Behavioral: Supervised Exercise; Behavioral: Home-based Exercise; Behavioral: Reduced Energy Diet; Behavioral: Group Phone Calls |
| B: High Risk Women | Experimental | Participants will include women at high risk of breast cancer who take part in a weight loss intervention program. The intervention is the same for all participants. Receives: Behavioral: Supervised Exercise; Behavioral: Home-based Exercise; Behavioral: Reduced Energy Diet; Behavioral: Group Phone Calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to supervised exercise sessions
Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant.
Measured: Week 12
Secondary outcomes (1)
Percent participants meeting physical activity goal
Measured as percentage of participants meeting final physical activity goal between week 9 to week 12. Measurement based off activity tracker participants will wear.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start25 Sep 2017
- Primary completion24 Jul 2018
- Study completion24 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carol Fabian, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carol Fabian, MD, University of Kansas Medical Center
- Investigators
- Carol Fabian, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270111
- Sponsor's protocol ID
- STUDY00141301
- Status last verified
- Dec 2024
- First submitted
- 30 Aug 2017
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fabian CJ, Klemp JR, Marchello NJ, Vidoni ED, Sullivan DK, Nydegger JL, Phillips TA, Kreutzjans AL, Hendry B, Befort CA, Nye L, Powers KR, Hursting SD, Giles ED, Hamilton-Reeves JM, Li B, Kimler BF. Rapid Escalation of High-Volume Exercise during Caloric Restriction; Change in Visceral Adipose Tissue and Adipocytokines in Obese Sedentary Breast Cancer Survivors. Cancers (Basel). 2021 Sep 28;13(19):4871. doi: 10.3390/cancers13194871.
PubMed 34638355
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women
- ClinicalTrials.gov ID
- NCT03270111
- Acronym / sponsor ID
- STUDY00141301
- Conditions
- Breast Cancer Female
- Keywords
- breast cancer survivor, weight loss program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Carol Fabian, MDUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 24 Jul 2018 (actual)
- Study completion
- 24 Jul 2018 (actual)
- First posted
- 1 Sep 2017 (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.
The purpose of this second pilot study is to extend the feasibility demonstrated in NCT02963740 that the intervention achieves high levels of moderate to vigorous physical activity (MVI PA) and modulates risk biomarkers for breast cancer and cardiovascular disease in older, obese sedentary breast cancer survivors who are undergoing moderate calorie restriction.
Detailed description
All subjects participate in same intervention. Intervention consists of a 6-month structured weight loss program utilizing portion controlled meals and a prescribed level of graduated physical activity with an eventual goal of 200 minutes or more per week. The program will include twice weekly sessions with a trainer at a local YMCA, and weekly phone group sessions the first 3 months with transition to unsupervised exercise and less frequent group phone sessions the second 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A2: Breast Cancer Survivor | Experimental | Behavioral: Supervised Exercise, Behavioral: Home-based Exercise, Behavioral: Reduced Energy Diet, Behavioral: Group Phone CallsParticipants will include breast cancer survivors who take part in a weight loss intervention program. The intervention is the same for all participants. |
| B: High Risk Women | Experimental | Behavioral: Supervised Exercise, Behavioral: Home-based Exercise, Behavioral: Reduced Energy Diet, Behavioral: Group Phone CallsParticipants will include women at high risk of breast cancer who take part in a weight loss intervention program. The intervention is the same for all participants. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of breast cancer having completed any cytotoxic chemotherapy, radiation or surgery at least 3 months prior to study entry (Cohort A2) OR No prior diagnosis of breast cancer but at high risk for development of breast cancer and participating in HSC 4601 (Cohort B)
- Body Mass Index (BMI) >30 kg/m2. Women with a BMI > 45 kg/m2 must be age < 60 and ability to perform physical activity must be confirmed
- By self-assessment, currently performing 60 minutes or less of purposeful exercise per week but able to walk at least 30 minutes on a level surface
- Possession of smart phone capable of running MyFitnessPal and Garmin Connect apps and willing to have diet and exercise data accessed by study personnel
- Access to a personal computer
Key exclusion criteria (7 listed)
- Use of metformin, insulin, steroids or prescription weight loss or anti-psychotic drugs within the prior 3 weeks
- Individuals with prior gastric bypass surgery or procedure that would impair absorption of nutrients
- Need for chronic immunosuppressive drugs
- Participation within the past 6 months on a structured weight loss program such as Weight Watchers®
- Physical impairments (bad hip, knees, feet, peripheral neuropathy) that would prohibit performing moderate intensity exercise at least 5 days per week.
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 |
|---|---|---|
| Supervised ExerciseParticipants will take part in supervised exercise activities two times per week at a YMCA. Length of the activity will be increased during participation in study. Participants will start at 40 minutes per week and work their way up to 120 minutes per week. | Behavioural | A2: Breast Cancer Survivor, B: High Risk Women |
| Home-based ExerciseAerobic exercise activities to be completed at home. Participants will be asked to start out doing 60 minutes at home and work up to 180 minutes of purposeful aerobic home exercise per week. | Behavioural | A2: Breast Cancer Survivor, B: High Risk Women |
| Reduced Energy DietDiet is a nutritionally balanced, reduced energy diet recommended by the Academy of Nutrition and Dietetics. | Behavioural | A2: Breast Cancer Survivor, B: High Risk Women |
| Group Phone CallsSessions are weekly months 1-3 and every other week months 4-6. The calls will discuss lifestyle changes specific to participants and cover the effects of diet, physical activity, and weight on breast cancer risk, as well as body image and emotional eating. | Behavioural | A2: Breast Cancer Survivor, B: High Risk Women |
Primary outcome
Adherence to supervised exercise sessions
Time frame: Week 12
Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant.
1 secondary outcome
Percent participants meeting physical activity goal
Time frame: Week 12
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 18 Dec 2024.
- Results publication: PubMed 34638355Fabian CJ, Klemp JR, Marchello NJ, Vidoni ED, Sullivan DK, Nydegger JL, Phillips TA, Kreutzjans AL, Hendry B, Befort CA, Nye L, Powers KR, Hursting SD, Giles ED, Hamilton-Reeves JM, Li B, Kimler BF. Rapid Escalation of High-Volume Exercise during Caloric Restriction; Change in Visceral Adipose Tissue and Adipocytokines in Obese Sedentary Breast Cancer Survivors. Cancers (Basel). 2021 Sep 28;13(19):4871. doi: 10.3390/cancers13194871.
- Individual participant dataSharing planned: No
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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.
Carol Fabian, MD principal investigator
University of Kansas Medical 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 Supervised Exercise, Home-based Exercise and Reduced Energy Diet in people with Breast Cancer Female, run by Carol Fabian, MD 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 10 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 18 Dec 2024. 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?
Adherence to supervised exercise sessions (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03270111, which also lists 1 linked publication.
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 18 Dec 2024.