Study on Leucoselect Phytosome for Pre-Surgery Treatment of Early Stage Lung Cancer

Sponsor: VA Office of Research and Development

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04515004

Provider View

This clinical trial is exploring the use of a special grape seed extract, called Leucoselect Phytosome, as a treatment before surgery for patients with early stage lung cancer. The study aims to see if this natural treatment can help improve outcomes and reduce the chance of cancer returning.

Patient Parameters

Program Overview

Lung cancer is a major cause of cancer-related deaths, especially among veterans who are at higher risk due to smoking and exposure to environmental toxins. This study is testing a new treatment using Leucoselect Phytosome (LP), a grape seed extract with enhanced absorption, to see if it can be a safe and effective pre-surgery treatment for early stage lung cancer. The findings could lead to larger studies in the future.

Description

This study involves a phase IIa trial where 30 patients with early stage I and II lung cancer will take Leucoselect Phytosome (LP) by mouth for 2-3 weeks before their surgery to remove the cancer.

Screening: Patients suspected of having early stage lung cancer will be recruited from clinics. After agreeing to participate, patients will undergo various tests, including medical history review, physical exams, and lung function tests. Blood and urine samples will be collected for research, and a pregnancy test will be done for women who can have children.

Treatment: If diagnosed with stage I or II lung cancer, patients will take LP once a day until their surgery. During surgery, samples from the lung and other tissues will be collected to see how well LP is absorbed and if it causes any positive changes in the cancer cells. Patients will have weekly phone check-ins to monitor their health and any side effects.

Follow-up: After surgery, patients will have follow-up phone calls at 3-4 weeks, 6 months, and then annually for up to 4 years to monitor their health and the long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Suspected lung cancer lesions
  • Able to provide consent
  • Normal blood counts and liver function
  • Normal kidney function
  • Good overall health (ECOG status 0-1)
  • Confirmed stage I or II non-small cell lung cancer that can be surgically removed

Exclusion Criteria

  • Unable to provide consent due to cognitive or psychiatric issues
  • Allergic to grapes or similar products
  • Severe lung disease
  • Unstable heart conditions
  • Other active cancers (except certain skin cancers)
  • History of organ or bone marrow transplant
  • Pregnant or breastfeeding
  • Taking high doses of steroids
  • Blood clotting issues
  • Using grape products or drinking more than one glass of wine daily
  • Taking certain medications that affect liver enzymes
  • Participating in other clinical trials
  • Medical conditions that could interfere with the study

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