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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00079794
Other study ID # R21AT001020-01
Secondary ID Rosenzweig
Status Completed
Phase Phase 2
First received March 15, 2004
Last updated January 23, 2008
Start date September 2001
Est. completion date February 2004

Study information

Verified date January 2008
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

See Brief Summary


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date February 2004
Est. primary completion date February 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Iscar

mistletoe


Locations

Country Name City State
United States Thomas Jefferson University Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

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