← Back to Search

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
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

Study 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.Check my eligibility
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.See study design
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
Select...
I have suspicious lung lesions.
Select...
I am fully active or can carry out light work.
Select...
I am mentally capable of understanding and agreeing to participate.
Select...
My lung cancer is in an early stage and can be removed with surgery.

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
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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmaceutical Preparations
Secondary outcome measures
Histopathology: pathological response of resected tumor and Lymph nodes.
Tumor Ki-67 labeling index (LI), a marker of cell proliferation.
Tumor activated caspase 3.
Other outcome measures
15-HETE.
CRP.
IL-6.
+9 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
All qualified participants meeting entry criteria that are enrolled will receive 2-3 weeks of oral LP treatment.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,607 Previous Clinical Trials
3,306,005 Total Patients Enrolled
Jenny T. Mao, MDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
3 Previous Clinical Trials
133 Total Patients Enrolled

Media Library

Leucoselect Phytosome (Plant Extract) Clinical Trial Eligibility Overview. Trial Name: NCT04515004 — Phase 2
Lung Cancer Research Study Groups: Intervention
Lung Cancer Clinical Trial 2023: Leucoselect Phytosome Highlights & Side Effects. Trial Name: NCT04515004 — Phase 2
Leucoselect Phytosome (Plant Extract) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04515004 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still able to submit applications for this trial?

"Unfortunately, the clinical trial listed on clinicaltrials.gov is no longer recruiting participants as it was last edited on October 7th 2022. Despite this inactive state, a plethora of other medical studies are actively enrolling patients at this time with 1493 trials in total."

Answered by AI

Has the United States Food and Drug Administration given its imprimatur to leucoselect phytosome?

"A safety rating of two has been assigned to leucoselect phytosome due to limited clinical evidence demonstrating its efficacy and some data indicating that it is safe."

Answered by AI
~20 spots leftby Jan 2027