Iscar for Supplemental Care in Stage IV Lung Cancer

January 23, 2008 updated by: National Center for Complementary and Integrative Health (NCCIH)
The purpose of this study it to determine whether supplemental treatment with Iscar improves immune function and quality of life among Stage IV non-small cell lung carcinoma patients receiving conventional chemotherapy. Iscar is an herbal medicine made from the total plant extract of mistletoe. this preparation is already in use in Europe and its use in the US is likely to increase as cancer patients continue to seek alternative therapies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See Brief Summary

Study Type

Interventional

Enrollment

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stage IV NSCLC patients who receive standard chemotherapy

Exclusion criteria:

  • Known allergy to Viscum Album L.
  • Concomitant use of other mistletoe products
  • Concomitant use of mushroom glucan and proteoglycan extracts
  • Concomitant use of thymus extract products
  • Inability to self-report quality of life utilizing assessment tools
  • Ongoing steroid or ACTH therapy
  • Co-morbid immunocompromised state
  • Pregnancy
  • Participation in other clinical trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Steven Rosenzweig, MD, Jefferson Medical College of Thomas Jefferson University

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 Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

February 1, 2004

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

March 15, 2004

First Submitted That Met QC Criteria

March 15, 2004

First Posted (Estimate)

March 16, 2004

Study Record Updates

Last Update Posted (Estimate)

January 25, 2008

Last Update Submitted That Met QC Criteria

January 23, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AT001020-01 (U.S. NIH Grant/Contract)
  • Rosenzweig

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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