Metastatic Breast Cancer & Vegan Diet

Clinical Trials.gov Identifier: NCT03045289

Recruitment Status : Recruiting

First Posted : February 7, 2017

Last Update Posted : July 23, 2018

Sponsor:

University of Rochester

Collaborator:

Johns Hopkins University

Information provided by (Responsible Party):

Thomas M Campbell, University of Rochester

Study Details

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No Results Posted

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Study Description

Brief Summary:

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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