Back to resultsIscar for Supplemental Care in Stage IV Lung Cancer
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Iscar
mistletoe
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring lung cancer, herbal medicine, non-small cell cancer, Iscar, mistletoe
Eligibility 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
Sites / Locations
- Thomas Jefferson University
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00079794
First Posted
March 15, 2004
Last Updated
January 23, 2008
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00079794
Brief Title
Iscar for Supplemental Care in Stage IV Lung Cancer
Official Title
Iscar for Supplemental Care in Stage IV Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
lung cancer, herbal medicine, non-small cell cancer, Iscar, mistletoe
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Iscar
Intervention Type
Drug
Intervention Name(s)
mistletoe
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Rosenzweig, MD
Organizational Affiliation
Jefferson Medical College of Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Iscar for Supplemental Care in Stage IV Lung Cancer
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