The Effect of Berries on Lung Cancer Tumors

NCT00681512 | Terminated DMC

• 2 other identifiers: 08.0040BCC-LUN-07-002
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC; lung cancer; non small cell lung cancer; lung carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

berry powder DIETARY_SUPPLEMENT

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.

Also known as: berries, berry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Fruit

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ramesh Gupta, PhD

  James Graham Brown Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2008
• First Posted: May 21, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 6, 2018

Record last verified: 2018-02

Locations

US (1)