Mistletoe as Complementary Treatment in Patients With Advanced Non-small-cell Lung Cancer (NSCLC), Treated With Carboplatin/Gemcitabine Chemotherapy Combination.

NCT00516022 | Completed Phase 2

• 1 other identifier: Mistletoe.ctil
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Mistletoe extract is one of the most common complementary treatments used in Europe. Recent basic studies reported tumor response and survival prolongation in number of treatments with Mistletoe preparations. There are evidence based data for using this drug as side effect reducer when use in combination with chemotherapy regimen treatment. Other clinical data, although not well based is that complementary treatment when used in combination with the common oncology treatment has tumor response effect. Combinations with platinum compound and a third generation cytotoxic agent have been accepted as 'standard of care' for patients with advanced NSCLC. The combination of platinum compound and one of the new agents are associated with response rates of 30-40% and a median survival of 8-11 months for advanced NSCLC patients with good performance status. Study objective: Improvement in QOL, Improvement in the toxicity profile of the chemotherapy treatment.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Quality Of Life

  To check the effect of the treatment(or lack of it) on the quality of life of the patients enrolled to the trial.

  During the trial

• Improvement in QOL. Improvement in the toxicity profile of the chemotherapy treatment

  To check on the difference in QoL of all patients.

  During all the trial

Secondary Outcomes (2)

• Objective Response

  During all the duration of the trial

• Improvement in time to tumor progression (TTP) and survival Safety profile of mistletoe extract with combination of chemotherapy treatment

  During duration of all the trial

Study Arms (2)

Investigator product

EXPERIMENTAL

The patients randomized to this arm will receive the IP injections at home 3 times a week (the patients will inject the IP themselves).

Drug: Mistletoe extract

Control

OTHER

The patients randomized to this arm will continue to receive chemotherapy as usual without further treatment (unless prescribed by the Doctor).

Drug: Mistletoe extract

Interventions

Mistletoe extract DRUG

The drug will be administered 3 times a week at home.

Also known as: There's no drug to be administered in the control group.

Control; Investigator product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years
• Histology proven of NSCLC
• Stage IIIB or IV (TNM classification)
• Performance status \< 2 (ECOG classification
• Measurable disease with one or more disease sites measured by computed tomography (CT)
• Life expectancy of more than 12 weeks.
• Treatment combination of gemcitabine/carboplatin (GC)
• Sign of written informed consent -

You may not qualify if:

• Prior chemotherapy
• Prior radiation- allowed as long as the treatment was not targeted only site of measurable disease and given more than 3 weeks before entry the trial.
• Central nervous system metastases
• Hypercalcemia
• Other life threatening medical conditions
• Patients not able to comply with s.c. injections

Sponsors & Collaborators

• Rambam Health Care Campus: lead
• Weleda AG: collaborator

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gil Bar-Sela

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2007
• First Posted: August 14, 2007
• Study Start: April 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: May 1, 2011
• Last Updated: September 27, 2011

Record last verified: 2011-09

Locations

IL (1)