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Berry Interventional Trial (BIT) in Resected Non-Small Cell Lung Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

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Trial Information

Berry Interventional Trial (BIT) in Resected Non-Small Cell Lung Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Assessment of blueberry and black raspberry phenolics in plasma and urine

Outcome 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.

Outcome Time Frame:

upon completion of 4 to 5 weeks of daily consumption of berry powder

Safety Issue:

No

Principal Investigator

Ramesh Gupta, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James Graham Brown Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

08.0040

NCT ID:

NCT00681512

Start Date:

April 2008

Completion Date:

March 2014

Related Keywords:

  • Non Small Cell Lung Cancer
  • NSCLC
  • lung cancer
  • non small cell lung cancer
  • lung carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

James Graham Brown Cancer CenterLouisville, Kentucky  40202