Breast CancerNCT02940470
Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors
A study testing Calorie restricted diet plus exercise and Weight management classes in people with Breast Cancer and Obesity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
The primary objective of this pilot study is to determine the effect of weight loss on a wide range of biomarkers associated with risk of breast cancer recurrence in overweight and obese breast cancer survivors. Read more about this study
- Who is it for?
- Ages 44 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Obesity, Overweight
- What is being tested?
- Calorie restricted diet plus exercise and Weight management classes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Aug 2010
- 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 44 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- postmenopausal (defined as experiencing at least 12 months without a menstrual period)
- diagnosed with operable invasive breast cancer and treated with mastectomy or with lumpectomy and radiation
- completed all surgery, radiation, and systemic chemotherapy one to 12 months prior to enrollment
- BMI ≥ 27 kg/m2
- less than 7 servings of alcohol per week
- willing to be randomized into either group
- not planning to move away from the area during the period of study
- non-smoker
Who cannot join
- serious illness requiring medical treatment
- inability to participate in physical activity due to severe disability
- history of schizophrenia, psychosis or untreated major depression
- unwilling to commute to study site once per week
- failure to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The primary objective of this pilot study is to determine the effect of weight loss on a wide range of biomarkers associated with risk of breast cancer recurrence in overweight and obese breast cancer survivors. We hypothesized that weight loss would result in a statistically significant improvement in biomarkers associated with risk of breast cancer recurrence.
Read the detailed description
Women who are overweight, obese or gain weight after a breast cancer diagnosis are at greater risk for recurrence and death compared with lighter women. There have been a few studies examining the effects of different interventions on weight loss in breast cancer survivors but very few have examined the effect of weight loss interventions on circulating levels of markers associated with cancer risk. The overall objective of this proposal is to determine how weight loss affects circulating levels of biomarkers associated with breast cancer risk and recurrence, and quality of life of overweight and obese breast cancer survivors. The central hypothesis is that weight loss will decrease the levels of markers adversely associated with breast cancer and increase quality of life in these women. To test the central hypothesis the following specific aims will be pursued:
- To assess the effects of two different weight loss interventions on biomarkers associated with breast cancer risk and recurrence
- To assess the impact of the weight loss interventions on quality of life and sleep
- To assess the impact of weight loss on measures of bone health
- Conditions
- Breast Cancer, Obesity, Overweight
- Being tested
- Calorie restricted diet plus exercise, Weight management classes
- Medical subject headings
- Breast Neoplasms, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calorie restricted diet plus exerciseOther
Daily meals plus exercise providing 1000 kcal restriction per day for 12 weeks.
Weight management classesOther
Weekly 1-hour weight management classes for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Calorie restricted diet plus exercise | Experimental | See Intervention Description Receives: Other: Calorie restricted diet plus exercise |
| Weight management classes | Active comparator | See Intervention Description Receives: Other: Weight management classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured: 0, 6, 12, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionAug 2010
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 CancerStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Susan Raatz, PhD, MPH, RD, Principal investigator, USDA Grand Forks Human Nutrition Research CenterMindy S Kurzer, PhD, MPH, RD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940470
- Sponsor's protocol ID
- UMN999
- Other IDs
- U54CA116849, CPRC#2008NTLS107
- Status last verified
- Aug 2018
- First submitted
- 18 Oct 2016
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Arikawa AY, Kaufman BC, Raatz SK, Kurzer MS. Effects of a parallel-arm randomized controlled weight loss pilot study on biological and psychosocial parameters of overweight and obese breast cancer survivors. Pilot Feasibility Stud. 2017 Jul 10;4:17. doi: 10.1186/s40814-017-0160-9. eCollection 2018.
PubMed 28702218
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02940470
- Acronym / sponsor ID
- UMN999
- Conditions
- Breast Cancer, Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Oct 2016 (estimated)
- 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 primary objective of this pilot study is to determine the effect of weight loss on a wide range of biomarkers associated with risk of breast cancer recurrence in overweight and obese breast cancer survivors. We hypothesized that weight loss would result in a statistically significant improvement in biomarkers associated with risk of breast cancer recurrence.
Detailed description
Women who are overweight, obese or gain weight after a breast cancer diagnosis are at greater risk for recurrence and death compared with lighter women. There have been a few studies examining the effects of different interventions on weight loss in breast cancer survivors but very few have examined the effect of weight loss interventions on circulating levels of markers associated with cancer risk. The overall objective of this proposal is to determine how weight loss affects circulating levels of biomarkers associated with breast cancer risk and recurrence, and quality of life of overweight and obese breast cancer survivors. The central hypothesis is that weight loss will decrease the levels of markers adversely associated with breast cancer and increase quality of life in these women. To test the central hypothesis the following specific aims will be pursued:
- To assess the effects of two different weight loss interventions on biomarkers associated with breast cancer risk and recurrence
- To assess the impact of the weight loss interventions on quality of life and sleep
- To assess the impact of weight loss on measures of bone health
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calorie restricted diet plus exercise | Experimental | Other: Calorie restricted diet plus exerciseSee Intervention Description |
| Weight management classes | Active comparator | Other: Weight management classesSee Intervention Description |
Who may qualify
- Ages
- 44 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- postmenopausal (defined as experiencing at least 12 months without a menstrual period)
- diagnosed with operable invasive breast cancer and treated with mastectomy or with lumpectomy and radiation
- completed all surgery, radiation, and systemic chemotherapy one to 12 months prior to enrollment
- BMI ≥ 27 kg/m2
- less than 7 servings of alcohol per week
Key exclusion criteria (5 listed)
- serious illness requiring medical treatment
- inability to participate in physical activity due to severe disability
- history of schizophrenia, psychosis or untreated major depression
- unwilling to commute to study site once per week
- failure to provide written informed consent
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 |
|---|---|---|
| Calorie restricted diet plus exerciseDaily meals plus exercise providing 1000 kcal restriction per day for 12 weeks. | Other | Calorie restricted diet plus exercise |
| Weight management classesWeekly 1-hour weight management classes for 12 weeks. | Other | Weight management classes |
Primary outcome
Change in body weight
Time frame: 0, 6, 12, 18 weeks
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 3 Aug 2018.
- Derived from this study: PubMed 28702218Arikawa AY, Kaufman BC, Raatz SK, Kurzer MS. Effects of a parallel-arm randomized controlled weight loss pilot study on biological and psychosocial parameters of overweight and obese breast cancer survivors. Pilot Feasibility Stud. 2017 Jul 10;4:17. doi: 10.1186/s40814-017-0160-9. eCollection 2018.
- 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.
Susan Raatz, PhD, MPH, RD principal investigator
USDA Grand Forks Human Nutrition Research Center
Mindy S Kurzer, PhD, MPH, RD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calorie restricted diet plus exercise and Weight management classes in people with Breast Cancer and Obesity, run by USDA Grand Forks Human Nutrition Research 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 8 inclusion and 5 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 3 Aug 2018. 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?
Change in body weight (time frame: 0, 6, 12, 18 weeks). 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 NCT02940470, 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 3 Aug 2018.