Metastatic Breast Cancer & Vegan Diet

 

ClinicalTrials.gov Identifier: NCT03045289

Recruitment Status : Recruiting

First Posted : February 7, 2017

Last Update Posted : July 23, 2018

See Contacts and Locations

Sponsor:

University of Rochester

Collaborator:

Johns Hopkins University

Information provided by (Responsible Party):

Thomas M Campbell, University of Rochester

Study Description

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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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer

Breast Cancer Stage IV

Behavioral: Plant-Based Diet Not Applicable

Study Design

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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

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

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.

Source

 

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