Iscar for Supplemental Care in Stage IV Lung Cancer

This study has been completed.

Sponsor:

Information provided by:

National Center for Complementary and Alternative Medicine (NCCAM)

ClinicalTrials.gov Identifier:

NCT00079794

First received: March 15, 2004

Last updated: January 23, 2008

Last verified: January 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

March 15, 2004

Last Updated Date

January 23, 2008

Start Date ^ICMJE

September 2001

Primary Completion Date

February 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00079794 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Iscar for Supplemental Care in Stage IV Lung Cancer

Official Title ^ICMJE

Iscar for Supplemental Care in Stage IV Lung Cancer

Brief Summary

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.

Detailed Description

See Brief Summary

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Lung Cancer

Intervention ^ICMJE

Drug: Iscar
Drug: mistletoe

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2004

Primary Completion Date

February 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00079794

Other Study ID Numbers ^ICMJE

R21 AT001020-01, Rosenzweig

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Steven Rosenzweig, MD

Jefferson Medical College of Thomas Jefferson University

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top