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Grape seed extract studied as Pre-Surgery lung cancer treatment

NCT ID NCT04515004

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a special grape seed extract (leucoselect phytosome) given before surgery to people with early-stage lung cancer. The goal was to see if it was safe and could slow tumor growth. Only 6 people took part, and the study was stopped early, so we don't have clear answers yet.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

6 people

The number who actually took part.

Started

Nov 2023

Finished

Mar 2025

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: A. Initial screening: * Lesions suspicious for lung cancer * Competent to provide consent * CBC within normal limits (WNL) * liver function test WNL * Normal Creatinine clearance as measured by the Cockcroft-Gault equation * ECOG Performance status: 0-1 B. Enrollment for treatment with LP: * Histologically proven and surgically resectable clinical I and II stage NSCLC Exclusion Criteria: * Inability to provide informed consent (e.g. cognitive impairment, severe psychiatric disorders) * Hypersensitivity to grapes or related products * Advance respiratory disease (Post resection FEV1 \< 0.8 liters, resting hypoxemia, to ensure pts have adequate reserve to undergo diagnostic procedures and surgical resection) * Unstable angina * Other concurrent malignancy, excluding non-melanoma type skin cancer * Have had a solid organ or bone marrow transplant * Pregnancy * Breast feeding * Systemic corticoid steroid therapy of \> 10 mg prednisone equivalent daily * Coagulopathy (PT-INR \> 1.2, PTT \> 40 seconds) or history of bleeding/clotting problems * Concurrent use of Grapes or related products * Unwilling to refrain from drinking more than 1 glass of wine a day * Pts receiving medications known to be modulators of cytochrome P450 3A4 if alternative medication cannot be provided * Currently taking other investigational agents * Pts with concurrent medical conditions that may interfere with completion of tests, therapy, or the follow up schedule

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Conditions

The condition(s) this trial relates to.

lung cancer non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early stage lung cancer (I and II)

Contacts and locations

Locations

  • VA San Diego Healthcare System, San Diego, CA

    San Diego, California, 92161-0002, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.