The Effect of Berries on Lung Cancer Tumors

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00681512
• Other study ID #: 08.0040
• Secondary ID: BCC-LUN-07-002
• Status: Terminated
• Phase: N/A
• First received: May 19, 2008
• Last updated: February 3, 2018
• Start date: April 2008
• Est. completion date: December 2013

Study information

• Verified date: February 2018
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	James Graham Brown Cancer Center	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	James Graham Brown Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	upon completion of 4 to 5 weeks of daily consumption of berry powder

External Links

•   Search for clinical trials at the James Graham Brown Cancer Center