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2016-06
2022-09
2022-09
290
NCT02948309
Karolinska University Hospital
Karolinska University Hospital
INTERVENTIONAL
Mistletoe Therapy in Primary and Recurrent Inoperable Pancreatic Cancer
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).
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-09-13 | N/A | 2023-01-12 |
2016-10-26 | N/A | 2023-01-13 |
2016-10-28 | N/A | 2023-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Mistletoe extract (Iscador Qu) 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)
|
| PLACEBO_COMPARATOR: Placebo isotonic saline solution, subcutaneous use 3 injections/week | DRUG: Placebo
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS defined as time from randomization to death for any reason | End of study (estimated 3 years) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Quality of Life questionnaire EORTC QLQ-C30 | Evaluation according to EORTC QLQ-C30 Scoring Manual | At 7 visits during study (9 months) |
| Quality of Life questionnaire EORTC PAN -26 | Evaluation according to EORTC PAN-26 Scoring Manual | At 7 visits during study (9 months) |
| Weight in kilograms, height in meters, BMI in kg/m^2 | Body weight, Body Mass Index | 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 | At 7 visits during study (9 months) |
| Number of visits of homecare team per week | Costs for supportive care | At 7 visits during study (9 months) |
| Use of oral nutrition support per week (number used per day) | Costs for supportive care | At 7 visits during study (9 months) |
| Use of symptom relieving medication in mg/day (painkillers, antiemetic and anxiolitic medication) | Costs for supportive care | At 7 visits during study (9 months) |
| Chemotherapy use (number of cycles first line, second line, ..) and dose reduction in% | Costs for supportive care | At 7 visits during study (9 months) |
| Number of parenteral nutrition infusions per week | Costs for supportive care | At 7 visits during study (9 months) |
| Days of unplanned inpatient care | Costs for inpatient care | At 7 visits during study (9 months) |
| Incidence of treatment-emergent adverse events (AE) | Safety | Through study completion (9 months) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
