The Effect of Berries on Lung Cancer Tumors

NCT ID: NCT00681512

Last Updated: 2018-02-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2013-12-31

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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

berries; berry

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

James Graham Brown Cancer Center

OTHER

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Ramesh Gupta

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ramesh Gupta, PhD

Role: PRINCIPAL_INVESTIGATOR

James Graham Brown Cancer Center

Locations

James Graham Brown Cancer Center

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

BCC-LUN-07-002

Identifier Type: OTHER

Identifier Source: secondary_id

08.0040

Identifier Type: -

Identifier Source: org_study_id