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CompletedNCT02940470Updated Aug 3, 2018

Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors

An interventional study of Calorie restricted diet plus exercise and Weight management classes in Breast Cancer, Obesity and Overweight, sponsored by USDA Grand Forks Human Nutrition Research Center. Completed at 1 site in United States. Open to female participants aged 44 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-08-03.

Sponsored by USDA Grand Forks Human Nutrition Research Center · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
44 Years to 75 Years
Sex
Female
01

Study 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. 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
02

Conditions studied

  • Breast Cancer
  • Obesity
  • Overweight
03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's enrollment of 22 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

USDA Grand Forks Human Nutrition Research Center is the lead sponsor of 60 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
44 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Calorie restricted diet plus exercise

    See Intervention Description

    Other: Calorie restricted diet plus exercise

  • Active comparator
    Weight management classes

    See Intervention Description

    Other: Weight management classes

Interventions

  • OtherCalorie restricted diet plus exercise

    Daily meals plus exercise providing 1000 kcal restriction per day for 12 weeks.

  • OtherWeight management classes

    Weekly 1-hour weight management classes for 12 weeks.

06

What researchers measure

Primary outcomes

  1. Change in body weight

    Time frame: 0, 6, 12, 18 weeks

07

Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2009, a primary completion of Jan 2010 and a completion of Aug 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2016
First posted
Oct 21, 2016
Start
Jan 2009
Primary completionActual
Jan 2010
CompletionActual
Aug 2010
Last update
Aug 3, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02940470
Lead sponsor
USDA Grand Forks Human Nutrition Research Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Oct 21, 2016
Start date
Jan 2009
Primary completion
Jan 2010
Completion
Aug 2010
Last update
Aug 3, 2018

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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