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The Effect of Berries on Lung Cancer Tumors

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ClinicalTrials.gov Identifier: NCT00681512
Recruitment Status : Terminated (slow accrual)
First Posted : May 21, 2008
Last Update Posted : February 6, 2018
Sponsor:
Collaborator:
James Graham Brown Cancer Center
Information provided by (Responsible Party):
Ramesh Gupta, University of Louisville

Tracking Information
First Submitted Date  ICMJE May 19, 2008
First Posted Date  ICMJE May 21, 2008
Last Update Posted Date February 6, 2018
Study Start Date  ICMJE April 2008
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2013)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2008)
Biological specimens (blood, urine, lung tissue, bronchoalveolar lavage fluid, and sputum) will be collected to measure the effect of the berry treatment. [ Time Frame: pre-treatment and post-treatment ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Berries on Lung Cancer Tumors
Official Title  ICMJE Berry Interventional Trial (BIT) in Resected Non-Small Cell Lung Cancer
Brief Summary The purpose of this study is to determine how berries affect cancer tumors in patients with non-small cell lung cancer.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 18, 2014)
6
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2008)
12
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00681512
Other Study ID Numbers  ICMJE 08.0040
BCC-LUN-07-002 ( Other Identifier: Brown Cancer Center Clinical Trials Office )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ramesh Gupta, University of Louisville
Study Sponsor  ICMJE University of Louisville
Collaborators  ICMJE James Graham Brown Cancer Center
Investigators  ICMJE
Principal Investigator: Ramesh Gupta, PhD James Graham Brown Cancer Center
PRS Account University of Louisville
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP