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Plant Extract

Grape Seed Extract for Early Stage Lung Cancer

Phase 2

Recruiting

Led By Jenny T. Mao, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Lesions suspicious for lung cancer

ECOG Performance status: 0-1

Must not have

Unstable angina

Coagulopathy (PT-INR > 1.2, PTT > 40 seconds) or history of bleeding/clotting problems

Timeline

Screening 3 weeks

Treatment Varies

Follow Up interim analysis on matched, pre- and post-treatment comparisons will be performed after 10 subjects have completed the treatment portion of the study, anticipated to be in year 2

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the effectiveness of a grape seed extract in preventing lung cancer in veterans.

Who is the study for?

This trial is for early stage lung cancer patients who can consent, have a good performance status (0-1), normal blood counts and liver function, and lesions likely to be lung cancer. They must not have advanced respiratory disease, be pregnant or breastfeeding, take certain drugs affecting the liver enzyme P450 3A4, or consume more than one glass of wine daily.

What is being tested?

The study tests leucoselect phytosome (LP), a grape seed extract with enhanced absorption as pre-surgical treatment for early stage lung cancer. It's based on promising earlier results suggesting LP might improve outcomes and reduce recurrence in these patients.

What are the potential side effects?

While specific side effects are not listed here, participants should watch out for any unusual symptoms since LP is derived from grapes; those with grape hypersensitivity may experience allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have suspicious lung lesions.

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I am fully active or can carry out light work.

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I am mentally capable of understanding and agreeing to participate.

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My lung cancer is in an early stage and can be removed with surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have unstable chest pain.

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I have a bleeding or clotting disorder.

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I am currently consuming grapes or grape-related products.

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I am taking more than 10 mg of prednisone or its equivalent daily.

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I have had a solid organ or bone marrow transplant.

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I am able to understand and consent to medical procedures.

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I have no other cancers except for non-melanoma skin cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ interim analysis on matched, pre- and post-treatment comparisons will be performed after 10 subjects have completed the treatment portion of the study, anticipated to be in year 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~interim analysis on matched, pre- and post-treatment comparisons will be performed after 10 subjects have completed the treatment portion of the study, anticipated to be in year 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and interim analysis on matched, pre- and post-treatment comparisons will be performed after 10 subjects have completed the treatment portion of the study, anticipated to be in year 2 for reporting.