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Effects of Selected Vegetable and Herb Mix (SV) on Advanced Non-small Cell Lung Cancer

NCT00246727 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2011-10-31

No results posted yet for this study

Summary

The primary objective of these two studies is to test the hypothesis that the daily ingestion of a dietary supplement, Selected Vegetables and Herbs Mix (SV), which consists of non-toxic botanicals containing known anti-cancer and/or immune enhancing components, may prolong the survival time of stage IIIB/IV non-small cell lung cancer (NSCLC) patients. Either SV or placebo will be added to their daily diet in a double-blind randomized fashion, so that there will be 2 chances out of 3 of receiving SV and 1 chance out of 3 of receiving placebo.

* Study 1: For newly diagnosed patients who will be receiving or have received less than 4 weeks of, a standard chemotherapy regimen.
* Study 2: For those who have stopped or refuse standard chemotherapy but will receive best supportive care.

Conditions

Interventions

DRUG

Selected Vegetable and Herb Mix

The phytomix consists of 19 vegetable and herbs in a highly concentrated form. These vegetables and herbs were selected based on their anti-cancer and immune-enhancing activities. Each batch of raw materials has gone through a very strict quality control (QC) scheme to make sure the product meets our QC standards and devoid of deleterious contaminations, such as heavy metals, pesticides, aflatoxin, and microorganisms. The manufacturing process is tightly controlled to ensure batch-to-batch consistency. The final product, a 20 gram freeze-dried powder, is sealed in a pouch. In our previous studies, patients who ingested phytomix daily for 17-60 months showed no clinical sign of adverse effect.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Sun Farm Corporation

    lead OTHER

Principal Investigators

  • Henry S Sacks, MD, Ph.D · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00246727 on ClinicalTrials.gov