Mistletoe Therapy in Primary and Recurrent Inoperable Pancreatic Cancer (MISTRAL)
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|ClinicalTrials.gov Identifier: NCT02948309|
Recruitment Status : Recruiting
First Posted : October 28, 2016
Last Update Posted : June 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Mistletoe extract (Iscador Qu) Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||290 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Mistletoe Therapy in Primary & Recurrent Inoperable Pancreatic Cancer. A Phase III Prospective Randomized Double Blinded Multicenter Parallel Group Placebo Controlled Clinical Trial on Overall Survival and Quality of Life|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
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)
1ml subcutaneous injection 3 times/week, dose escalation 0,01mg - 20mg
Other Name: Fermented aqueous extract of Viscum album ssp album (L.)
Placebo Comparator: Placebo
isotonic saline solution, subcutaneous use 3 injections/week
1ml subcutaneous injection 3 times/week
Other Name: Isotonic saline solution
- Overall survival (OS) [ Time Frame: End of study (estimated 3 years) ]OS defined as time from randomization to death for any reason
- Quality of Life questionnaire EORTC QLQ-C30 [ Time Frame: At 7 visits during study (9 months) ]Evaluation according to EORTC QLQ-C30 Scoring Manual
- Quality of Life questionnaire EORTC PAN -26 [ Time Frame: At 7 visits during study (9 months) ]Evaluation according to EORTC PAN-26 Scoring Manual
- Weight in kilograms, height in meters, BMI in kg/m^2 [ Time Frame: At 7 visits during study (9 months) ]Body weight, Body Mass Index
- Corticosteroid use in milligrams betamethasone per day and indication (appetite, chemotherapy, nausea, pain, general wellbeing, other: specified) [ Time Frame: At 7 visits during study (9 months) ]Corticosteroid use and indication
- Number of visits of homecare team per week [ Time Frame: At 7 visits during study (9 months) ]Costs for supportive care
- Use of oral nutrition support per week (number used per day) [ Time Frame: At 7 visits during study (9 months) ]Costs for supportive care
- Use of symptom relieving medication in mg/day (painkillers, antiemetic and anxiolitic medication) [ Time Frame: At 7 visits during study (9 months) ]Costs for supportive care
- Chemotherapy use (number of cycles first line, second line, ..) and dose reduction in% [ Time Frame: At 7 visits during study (9 months) ]Costs for supportive care
- Number of parenteral nutrition infusions per week [ Time Frame: At 7 visits during study (9 months) ]Costs for supportive care
- Days of unplanned inpatient care [ Time Frame: At 7 visits during study (9 months) ]Costs for inpatient care
- Incidence of treatment-emergent adverse events (AE) [ Time Frame: Through study completion (9 months) ]Safety
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948309
|Contact: Kathrin Wode, MD||+46 8 585 828 firstname.lastname@example.org|
|Contact: Roger Henriksson, Prof||+46-8 email@example.com|
|Stockholm, Sweden, 14186|
|Contact: Kathrin Wode, MD +46-8-12314261;+46-707-374261 firstname.lastname@example.org|
|Contact: Maura Krook, study nurse 08-58582864, 073-9660811 email@example.com|
|Study Chair:||Annika Bergquist, Ass Prof||Gastrocentrum Karolinska University Hospital|