Iscar for Supplemental Care in Stage IV Lung Cancer | NCT00079794

Studies
Iscar for Supplemental Care in Stage IV Lung Cancer

NCT00079794

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Status

Completed

Last Update Posted

Jan 25, 2008Estimated

Enrollment

Phase

Phase 2

Conditions

Lung Cancer

Interventions

Iscar
mistletoe

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Rosenzweig

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Sep 2001

Primary Completion Date

Feb 2004Actual

Completion Date

Feb 2004Actual

First Submitted Date

Mar 15, 2004

First Submission Date that Met QC Criteria

Mar 15, 2004

First Posted Date

Mar 16, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2008

Last Update Posted Date

Jan 25, 2008Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven Rosenzweig, MD	Jefferson Medical College of Thomas Jefferson University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thomas Jefferson University		Philadelphia	Pennsylvania	19107	United States

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Iscar	Drug
mistletoe	Drug