ClinicalTrials.gov Identifier: NCT03045289
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : July 23, 2018
University of Rochester
Johns Hopkins University
Information provided by (Responsible Party):
Thomas M Campbell, University of Rochester
This research will examine the feasibility of conducting a strict whole-food, plant-based dietary intervention in women with stable metastatic breast cancer currently undergoing conventional treatments. In addition, this research will provide preliminary data on dietary intakes and the effect of plant-based nutrition on numerous outcomes reflecting cancer prognosis and overall health using advanced imaging, various blood biomarkers linked to cancer progression, and numerous symptom questionnaires.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer
Breast Cancer Stage IV
|Behavioral: Plant-Based Diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Whole-Food, Plant-Based Nutrition Among Women With Metastatic Breast Cancer: A Pilot Study of Recruitment, Retention, and Preliminary Changes in Biomarkers and Symptoms.|
|Actual Study Start Date :||January 5, 2018|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||October 1, 2019|
Resource links provided by the National Library of Medicine
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Have a diagnosis of HR+, HER2− metastatic breast cancer (mBC).
- Have all of the following:
- Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy.
- Prior treatment with chemotherapy for locally advanced or metastatic disease.
- No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.
- Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.
- Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.
- Have adequate organ function.
- Women of child-bearing potential must have a negative pregnancy test.
- Are able to swallow tablets/capsules.
- Are currently receiving treatment in a clinical study involving an investigational product.
- Have a serious concomitant systemic disorder.
- Have symptomatic central nervous system (CNS) malignancy or metastasis.
- Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.
- Have a personal history of syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
- Have a history of any other cancer.
- Had major surgery within 14 days prior to randomization.
- Are breastfeeding.
- Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.