Using grape seed extract to treat early stage lung cancer before surgery
Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer
This study is testing if a special grape seed extract can help people with early stage lung cancer feel better before they have surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Drugs / interventions | prednisone |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT04515004 on ClinicalTrials.gov |
What this trial studies
This phase IIa clinical trial aims to evaluate the effectiveness of leucoselect phytosome, a specialized grape seed extract, as a neoadjuvant treatment for patients with early stage lung cancer (stages I and II). The study will involve 30 patients who will receive 2-3 weeks of oral treatment with the extract prior to surgical resection of their tumors. Participants will be screened for eligibility based on specific health criteria and will undergo various diagnostic tests to ensure they meet the study requirements. The goal is to improve treatment strategies and outcomes for lung cancer patients.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically proven, surgically resectable early stage non-small cell lung cancer.
Not a fit: Patients with advanced respiratory diseases, other concurrent malignancies, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance the effectiveness of surgical interventions and reduce the recurrence of lung cancer.
How similar studies have performed: While this approach is based on promising preclinical findings, it represents a novel application in the context of neoadjuvant treatment for lung cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Diego, California
- VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Jenny T. Mao, MD — VA San Diego Healthcare System, San Diego, CA
- Study coordinator: Jenny T Mao, MD
- Email: jenny.mao@va.gov
- Phone: (858) 642-6403
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.