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The Effect of Berries on Lung Cancer Tumors

Primary Purpose

Non Small Cell Lung Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
berry powder
Sponsored by
University of Louisville
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Non Small Cell Lung Cancer focused on measuring NSCLC, lung cancer, non small cell lung cancer, lung carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • James Graham Brown Cancer Center

Outcomes

Primary Outcome Measures

Assessment of blueberry and black raspberry phenolics in plasma and urine
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.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2008
Last Updated
February 3, 2018
Sponsor
University of Louisville
Collaborators
James Graham Brown Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00681512
Brief Title
The Effect of Berries on Lung Cancer Tumors
Official Title
Berry Interventional Trial (BIT) in Resected Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
James Graham Brown Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
NSCLC, lung cancer, non small cell lung cancer, lung carcinoma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
berry powder
Other Intervention Name(s)
berries, berry
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of blueberry and black raspberry phenolics in plasma and urine
Description
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.
Time Frame
upon completion of 4 to 5 weeks of daily consumption of berry powder

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramesh Gupta, PhD
Organizational Affiliation
James Graham Brown Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Links:
URL
https://uoflbrowncancercenter.org/clinical-trials
Description
Search for clinical trials at the James Graham Brown Cancer Center

Learn more about this trial

The Effect of Berries on Lung Cancer Tumors

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