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The Effect of Berries on Lung Cancer Tumors

This study is currently recruiting participants.
Verified May 2013 by James Graham Brown Cancer Center
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT00681512
First received: May 19, 2008
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to determine how berries affect cancer tumors in patients with non-small cell lung cancer.


Condition Intervention
Non Small Cell Lung Cancer
 Dietary Supplement: berry powder

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Berry Interventional Trial (BIT) in Resected Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by James Graham Brown Cancer Center:

Primary Outcome Measures:
  • Assessment of blueberry and black raspberry phenolics in plasma and urine [ Time Frame: upon completion of 4 to 5 weeks of daily consumption of berry powder ] [ Designated as safety issue: No ]
    In addition to determining the berry phytochemical profile in plasma and urine, this study will attempt to establish the effect of berries on modulating immunological profiles such as the complete blood count, and T, B and natural killer (NK) cell populations and circulating biomarkers (serum proteins and microRNAs). This pilot study will establish the safety and feasibility of conducting a larger clinical trial with berry intervention.


Estimated Enrollment: 24
Study Start Date: April 2008
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: berry powder

    All subjects (lung cancer survivors and volunteers) will consume 20 grams of berry powder (blueberries, black raspberries, or a mixture of both) per day by mouth for the first 3 days, then 40 grams of berry powder by mouth every day for 4 to 5 weeks.

    The berry powder is to be mixed in subject's routine intake of milk, yogurt, juice, or water.

    All subjects will have the option to continue the berry regimen for an extended period. Subjects who choose to do so will not consume any berry powder for one week. After one week, subjects will begin consuming 40 grams of the berry powder every day for an additional 4 to 5 weeks.

    Other Names:
    • berries
    • berry
Detailed Description:

In the United States, more people (161,840 per year) die of lung cancers than of prostate cancer, breast cancer and colon cancer combined. Presently, there are over 43 million current smokers and over 47 million ex-smokers living in the US. Due to the lag time between smoking and the development of cancer, there are significant numbers of ex-smokers and current smokers who may develop lung cancer compared to never smokers.

Recent studies in animals have shown that berries, given as a dietary supplement, are highly effective against certain types of cancers. In a study involving mice with lung tumors, mice that had consumed a mixture of berries developed fewer tumors and had less tumor growth than mice that did not consume berries.

The berries used in this study will consist of blueberries, black raspberries, or a mixture of both.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (lung cancer survivors):

  • men treated for lung cancer, women treated for lung cancer and with no child-bearing potential (hysterectomy, tubal ligation, post-menopausal women)

Exclusion Criteria (lung cancer survivors):

  • women who are on hormone replacement therapy
  • women who are pregnant, or planning for pregnancy
  • history of lung transplant
  • prison inmate
  • inability to take oral medication or food
  • known or suspected allergy to berries or berry products
  • HIV patients

Inclusion Criteria (volunteers):

  • adult men, adult women with no child bearing potential (hysterectomy, tubal ligation, post-menopausal women)

Exclusion Criteria (volunteers):

  • women who are on hormone replacement therapy
  • women who are pregnant, or planning for pregnancy
  • history of lung transplant
  • prison inmate
  • inability to take oral medication or food
  • known or suspected allergy to berries or berry products
  • HIV patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681512

Contacts
Contact: Radha Munagala (502) 852-3684 r0muna01@louisville.edu

Locations
United States, Kentucky
James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Principal Investigator: Ramesh Gupta, PhD            
Sponsors and Collaborators
James Graham Brown Cancer Center
University of Louisville
Investigators
Principal Investigator: Ramesh Gupta, PhD James Graham Brown Cancer Center
  More Information

No publications provided

Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT00681512     History of Changes
Other Study ID Numbers: 08.0040, BCC-LUN-07-002
Study First Received: May 19, 2008
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by James Graham Brown Cancer Center:
NSCLC
lung cancer
non small cell lung cancer
lung carcinoma

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013