A Phase 3 interventional study of Mistletoe extract (Iscador Qu) and Placebo in Pancreatic Cancer, sponsored by Karolinska University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-13.
Sponsored by Karolinska University Hospital · Phase 3, Interventional, and Treatment
In this study a mistletoe preparation (Iscador Qu) is added to standard therapy in inoperable pancreatic cancer in order to evaluate effect on overall survival and health-related quality of life. Half of participants will take subcutaneous injections with mistletoe in addition to standard therapy (palliative chemotherapy or best supportive care); the other half will receive a placebo and standard therapy.
Extracts from European mistletoe (Viscum album L.) have been used as complementary cancer therapy since the 1920s. To date over 160 clinical studies on mistletoe in cancer therapy have been conducted with varying quality; the therapy is still controversial.
Best evidence is found for increase of health-related quality of life (HRQoL) and reduction of side effects of conventional therapies (chemotherapy, radiation) in breast cancer patients. Mistletoe treatment is described as safe and well tolerated. There are some clinical studies supporting the use of mistletoe extract in the management of late stage cancer.
Statistically significant effects on overall survival (OS) and HRQoL in pancreatic cancer patients have recently been shown in a randomized open label trial in Serbia investigating the addition of mistletoe extract to best supportive care. The results are questioned because patients knew what kind of treatment they received.
Mistletoe extracts are usually administered subcutaneously. They contain a multitude of substances with immune modulatory and cytotoxic or - in animal studies - antitumorigenic, anti-metastatic and antiangiogenic effects.
This trial investigates whether there is a beneficial effect of mistletoe extracts on OS and HRQoL in pancreatic cancer patients receiving standard treatment (palliative chemotherapy or best supportive care).
Inclusion has started at 4 study centers (2 more centers are waiting for participation). And participants are randomized 1:1 to mistletoe treatment (Iscador Qu®) given in increasing dosage from 0,01mg to 20 mg or placebo injections subcutaneously 3 times /week. Stratification will be performed for received oncological treatment (palliative chemotherapy or best supportive care). At 7 visits in 9 months, participants fill in the validated EORTC QLQ-C30 (QLO=quality of life questionnaire) and PAN-26 (PAN=pancreas) quality of life questionnaires. Body weight, use of cancer-related medicines, substitution of nutrition, adverse events need of supportive care and inpatient care are measured. To be able to assess more dimensions of quality of life than possible with questionnaires, a qualitative sub-study with interviews on about 30 participants in this trial is performed in month 3. A 2nd substudy has been added november 2016 to elucidate the systemic effects of mistletoe therapy and to explore potential prognostic and predictive biomarkers (anticipated n=100).
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 290 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Karolinska University Hospital is the lead sponsor of 275 studies on the registry; 54 are open to participants now.
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Signed written informed consent
Inoperable locally advanced or metastatic pancreatic cancer or relapse of pancreatic cancer.
Exclusion Criteria:
Life expectancy less than 4 weeks
Fermented aqueous extract of Viscum album ssp album (L.) (mistletoe) = Iscador Qu, subcutaneous use 3 injections/week; dose escalation from 0,01mg - 20mg
Drug: Mistletoe extract (Iscador Qu)
isotonic saline solution, subcutaneous use 3 injections/week
Drug: Placebo
1ml subcutaneous injection 3 times/week, dose escalation 0,01mg - 20mg
Also known as: Fermented aqueous extract of Viscum album ssp album (L.)
1ml subcutaneous injection 3 times/week
Also known as: Isotonic saline solution
Overall survival (OS)
OS defined as time from randomization to death for any reason
Time frame: End of study (estimated 3 years)
Quality of Life questionnaire EORTC QLQ-C30
Evaluation according to EORTC QLQ-C30 Scoring Manual
Time frame: At 7 visits during study (9 months)
Quality of Life questionnaire EORTC PAN -26
Evaluation according to EORTC PAN-26 Scoring Manual
Time frame: At 7 visits during study (9 months)
Weight in kilograms, height in meters, BMI in kg/m^2
Body weight, Body Mass Index
Time frame: At 7 visits during study (9 months)
Corticosteroid use in milligrams betamethasone per day and indication (appetite, chemotherapy, nausea, pain, general wellbeing, other: specified)
Corticosteroid use and indication
Time frame: At 7 visits during study (9 months)
Number of visits of homecare team per week
Costs for supportive care
Time frame: At 7 visits during study (9 months)
Use of oral nutrition support per week (number used per day)
Costs for supportive care
Time frame: At 7 visits during study (9 months)
Use of symptom relieving medication in mg/day (painkillers, antiemetic and anxiolitic medication)
Costs for supportive care
Time frame: At 7 visits during study (9 months)
Chemotherapy use (number of cycles first line, second line, ..) and dose reduction in%
Costs for supportive care
Time frame: At 7 visits during study (9 months)
Number of parenteral nutrition infusions per week
Costs for supportive care
Time frame: At 7 visits during study (9 months)
Days of unplanned inpatient care
Costs for inpatient care
Time frame: At 7 visits during study (9 months)
Incidence of treatment-emergent adverse events (AE)
Safety
Time frame: Through study completion (9 months)
Plan to share: Yes — The trial results will be submitted for publication in relevant medical journals
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Karolinska University Hospital