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Breast CancerPhase 2NCT00811824

Effects of Physical Activity and Dietary Change in Minority Breast Cancer Survivors

A Phase 2 study testing Physical activity and dietary change in people with Breast Cancer, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is testing the effects of exercise and dietary change on weight reduction and biological markers associated with breast cancer risk in breast cancer survivors of Hispanic or African descent (n=45). Read more about this study

Who is it for?
Ages 21 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Physical activity and dietary change
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
Jul 2007to Nov 2012
Phase
Phase 2
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 21 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 21-70 yrs
  • Stage 0-IIIa breast cancer
  • No evidence of recurrent/metastatic disease
  • Hispanic or African descent (African-American or Caribbean)
  • BMI > 25kg/m2
  • Sedentary
Show all 13Show fewer
  • Completed surgery, chemotherapy, and radiation therapy ≥ 6 months
  • Blood pressure < 140/90
  • HgbA1C < 8
  • LDL cholesterol < 150
  • No uncontrolled comorbidities
  • VO2 max normal EKG changes
  • Non-smoker

Who cannot join

  • Evidence of recurrent or metastatic breast cancer
  • Uncontrolled co-morbid illness including, but not limited to, type I diabetes mellitus, type II diabetes mellitus, hypertension, symptomatic congestive heart failure, unstable angina pectoris, claudication, cardiac arrhythmia; active pulmonary disease; hypercholesterolemia, neurological condition, ischemic heart disease, cardiac disease, kidney disease, respiration problems, asthma, shortness of breath, physical limitations, abnormal thyroid function, active malignancy, except for squamous or basal cell carcinoma of the skin; receiving active chemotherapy or radiotherapy; or psychiatric illness/social situations that would limit compliance with study requirements
  • Currently taking Herceptin therapy, or abnormal echo or MUGA post-Herceptin therapy
  • Active tobacco use
  • Currently active in an exercise and/or dietary change weight loss program
  • If a participant develops a breast cancer recurrence or metastasis during the 12-month study period, her participation in the study will be terminated.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Columbia University

    New York, New York, 10032

Other trials in United States

About this study

This study is testing the effects of exercise and dietary change on weight reduction and biological markers associated with breast cancer risk in breast cancer survivors of Hispanic or African descent (n=45). This is a randomized, crossover pilot and feasibility study to test the effects of a 30-minute circuit-based exercise program that combines resistance training with aerobic exercise in conjunction with a low-fat calorie reduced diet. Participants will be randomized to either an immediate 6-months of exercise and dietary change, or a delayed group who will begin their exercise and dietary change program 6-months after the study begins. Participants in the immediate group will be followed for an additional 6-months in order to evaluate adherence to the exercise and dietary change recommendations. Participants in both groups will exercise at a neighborhood Curves® facility at least 5 times per week for six months and will participate in a series of nutrition education classes.

Conditions
Breast Cancer
Being tested
Physical activity and dietary change
Keywords
Weight loss, Physical activity, Dietary change
Medical subject headings
Breast Neoplasms, Weight Loss, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activity and dietary changeBehavioural

    6 months of combined resistance training and aerobic exercise (5 times per week x 30 minutes) plus 6-week nutrition counseling class

Study groups in NCT00811824
Study groupRoleWhat they receive
1Active comparatorImmediate physical activity and dietary change intervention
Receives: Behavioral: Physical activity and dietary change
2OtherDelayed physical activity and dietary change intervention
Receives: Behavioral: Physical activity and dietary change

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in weight

    Measured: 6 months, 12 months

  2. Intervention adherence

    Measured: 6 months, 12 months

Secondary outcomes (7)

  1. Barriers to participation

    Measured: 3 months, 6 months, 9 months, 12 months

  2. Predictors of adherence

    Measured: 3 months, 6 months, 9 months, 12 months

  3. Changes in anthropometric measures

    Measured: 3 months, 6 months, 9 months, 12 months

  4. Changes in fitness

    Measured: 3 months, 6 months, 9 months, 12 months

  5. Changes in hormonal biomarkers

    Measured: 3 months, 6 months, 9 months, 12 months

  6. Changes in metabolic markers

    Measured: 3 months, 6 months, 9 months, 12 months

  7. Changes in psychological and quality of life measures

    Measured: 3 months, 6 months, 9 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2008 (estimated)
  2. Study startJul 2007
  3. Primary completionSep 2009
  4. Study completionNov 2012

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00811824
Sponsor's protocol ID
AAAB8839
Status last verified
Feb 2013
First submitted
18 Dec 2008
Last updated
22 Feb 2013
Results posted
No
Data monitoring committee
No

Publications

  • Delgado-Cruzata L, Zhang W, McDonald JA, Tsai WY, Valdovinos C, Falci L, Wang Q, Crew KD, Santella RM, Hershman DL, Greenlee H. Dietary modifications, weight loss, and changes in metabolic markers affect global DNA methylation in Hispanic, African American, and Afro-Caribbean breast cancer survivors. J Nutr. 2015 Apr;145(4):783-90. doi: 10.3945/jn.114.202853. Epub 2015 Feb 4.

    PubMed 25833781

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Physical activity and dietary change in people with Breast Cancer, run by Columbia University 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 13 inclusion and 6 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 22 Feb 2013. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 weight (time frame: 6 months, 12 months). The study lists 2 primary outcomes in all. 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 NCT00811824, 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 22 Feb 2013.

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