TERMINATED

Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Lung cancer is the leading cause of cancer death in the country, surpassing deaths caused by colorectal, prostate and breast cancers combined. Veterans are at higher risk of lung cancer due to the higher rate of smoking and environmental toxin exposures. The lack of effective therapy for lung cancer provides the impetus to search for alternative, safe, and effective treatment agents to improve treatment strategy against lung cancer, enhance the probability of a cure and reduce recurrence. Based on encouraging preclinical and clinical findings from an early phase I lung cancer prevention study, using a special formulation of a standardized grape seed extract with enhanced absorption called leucoselect phytosome (LP), the purpose of this new CSR\&D Merit Review project is to evaluate the potential usefulness of LP for pre-surgical treatment of early stage lung cancer patients in a phase IIa clinical trial. Findings from this study may set the stage for larger, confirmatory trials in the near future.

Official Title

Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer

Quick Facts

Study Start:2023-11-20
Study Completion:2025-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04515004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Lesions suspicious for lung cancer
  2. * Competent to provide consent
  3. * CBC within normal limits (WNL)
  4. * liver function test WNL
  5. * Normal Creatinine clearance as measured by the Cockcroft-Gault equation
  6. * ECOG Performance status: 0-1
  7. * Histologically proven and surgically resectable clinical I and II stage NSCLC
  1. * Inability to provide informed consent (e.g. cognitive impairment, severe psychiatric disorders)
  2. * Hypersensitivity to grapes or related products
  3. * Advance respiratory disease (Post resection FEV1 \< 0.8 liters, resting hypoxemia, to ensure pts have adequate reserve to undergo diagnostic procedures and surgical resection)
  4. * Unstable angina
  5. * Other concurrent malignancy, excluding non-melanoma type skin cancer
  6. * Have had a solid organ or bone marrow transplant
  7. * Pregnancy
  8. * Breast feeding
  9. * Systemic corticoid steroid therapy of \> 10 mg prednisone equivalent daily
  10. * Coagulopathy (PT-INR \> 1.2, PTT \> 40 seconds) or history of bleeding/clotting problems
  11. * Concurrent use of Grapes or related products
  12. * Unwilling to refrain from drinking more than 1 glass of wine a day
  13. * Pts receiving medications known to be modulators of cytochrome P450 3A4 if alternative medication cannot be provided
  14. * Currently taking other investigational agents
  15. * Pts with concurrent medical conditions that may interfere with completion of tests, therapy, or the follow up schedule

Contacts and Locations

Principal Investigator

Jenny T. Mao, MD
PRINCIPAL_INVESTIGATOR
VA San Diego Healthcare System, San Diego, CA

Study Locations (Sites)

VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Jenny T. Mao, MD, PRINCIPAL_INVESTIGATOR, VA San Diego Healthcare System, San Diego, CA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-20
Study Completion Date2025-03-31

Study Record Updates

Study Start Date2023-11-20
Study Completion Date2025-03-31

Terms related to this study

Keywords Provided by Researchers

  • Grape seed procyanidin extract
  • Early stage lung cancer
  • Neoadjuvant treatment

Additional Relevant MeSH Terms

  • Early Stage Lung Cancer (I and II)