Mistletoe as Complementary Treatment in Patients With Advanced Non-small-cell Lung Cancer (NSCLC), Treated With Carboplatin/Gemcitabine Chemotherapy Combination: Randomized Phase II Study
The study design is to include 90 subjects. All subjects are treated with the common
chemotherapy treatment. 50 percent will be treated with Iscador as combination with their
common chemotherapy regimen. Common chemotherapy regimen used for NSCLC: Carboplatin and
Gemcitabine. All study participants will receive this same chemotherapy regimen. This
chemotherapy treatment is given every 3 weeks for up to 6 treatment cycles. The first day
of the first treatment cycle, the combination of both Carboplatin and Gemcitabine will be
administered. After a week (day 8 of treatment cycle) only Gemcitabine will be
administered. Drugs would be calculated according to patient's body mass, renal function
and general appearance. Once the patient signed Informed Consent he is assigned randomly to
be treated with/without the injections of Mistletoe (called "Iscador"). Patient will receive
the study medication (Iscador) as an intravenous injection that can be self injected or
injected by any other of the family. Injections would be administered with low dose at the
first week of the first treatment cycle and then, dose would be escalated, so as to check
high sensitivity to the drug. Dosage would include: 2 injections of 0.1 mg, 2 injections of
0.1 mg and 2 injections of 1 mg. After that, treatment would continue with dosage of 10 g
once every 2 days.
Patients from both treatment arms would be asked to fill-out QOL questionnaires at every
treatment cycle and at follow-up visit after.
Study Primary Objectives:
1. Improvement in QOL
2. Improvement in the toxicity profile of the chemotherapy treatment
1. Improvement in time to tumor progression (TTP) and survival.
2. Safety profile of mistletoe extract with combination of chemotherapy treatment
This is a single center study, randomized phase II, with patients with advanced NSCLC
treated with carboplatin/gemcitabine chemotherapy combination.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Rambam Health Care Campus
Israel: Ministry of Health