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Iscar for Supplemental Care in Stage IV Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
ClinicalTrials.gov Identifier:
NCT00079794
First received: March 15, 2004
Last updated: January 23, 2008
Last verified: January 2008
History of Changes
  Purpose
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.

Condition Intervention Phase
Lung Cancer
 Drug: Iscar
Drug: mistletoe
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Iscar for Supplemental Care in Stage IV Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):
Estimated Enrollment: 36
Study Start Date: September 2001
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Detailed Description:
See Brief Summary
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079794

Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Steven Rosenzweig, MD Jefferson Medical College of Thomas Jefferson University
  More Information

ClinicalTrials.gov Identifier: NCT00079794     History of Changes
Other Study ID Numbers: R21AT001020-01  Rosenzweig 
Study First Received: March 15, 2004
Last Updated: January 23, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
lung cancer
herbal medicine
non-small cell cancer
Iscar
mistletoe

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 29, 2016