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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
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 belowSelect...
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 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
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have suspicious lung lesions.You are currently breastfeeding.I am fully active or can carry out light work.I am taking medication that affects liver enzyme levels and cannot switch.Your complete blood count (CBC) is normal.My lung function is strong enough for surgery.I have unstable chest pain.I have a bleeding or clotting disorder.I am mentally capable of understanding and agreeing to participate.I am currently consuming grapes or grape-related products.I am taking more than 10 mg of prednisone or its equivalent daily.I have had a solid organ or bone marrow transplant.You are allergic to grapes or grape-related products.My lung cancer is in an early stage and can be removed with surgery.I do not have any health conditions that could affect my participation in the study.Your kidneys are working well, as measured by a test called the Cockcroft-Gault equation.I am able to understand and consent to medical procedures.I have no other cancers except for non-melanoma skin cancer.Your liver function test results are normal.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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