Mistletoe therapy for Advanced PAncreatic Cancer

ISRCTN	ISRCTN70760582
DOI	https://doi.org/10.1186/ISRCTN70760582
Secondary identifying numbers	29/07

Submission date: 08/12/2008
Registration date: 05/02/2009
Last edited: 30/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Wilfried Troger
Scientific

Zechenweg 6
Freiburg
79111
Germany

Study information

Study design	Group sequential randomised open label phase III study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Mistletoe therapy for advanced pancreatic cancer: a group sequential, randomised, phase III, open label study
Study acronym	MAPAC
Study hypothesis	Primary hypothesis: Patients receiving Iscador Qu Spzial (IQuS) will show a higher overall survival rate. Secondary hypothesis: Patients receiving IQuS will show improved (better) quality of life.
Ethics approval(s)	Ethics Committee of the Clinical Centres of Serbia gave approval on the 4th March 2008 (ref: 60/6)
Condition	Pancreatic cancer stage III and IV
Intervention	Subcutaneous (s.c.) injection of an extract of Viscum album (L.), the generic name of the investigational product is "Iscador Qu Spzial". The dosage begins for all patients in the verum group with an initial phase: 2 x 0.01 mg, 2 x 0.1 mg, 5 x 1 mg, 5 x 5 mg, and 10 mg. For the following maintenance phase, the highest dosage of 10 mg is recommended. During the initial and the maintenance phase the dosage will be modified according to the patients tolerability. The investigational product is injected subcutaneously 3 times weekly. Patients in the mistletoe group will administer the investigational product for 12 months. All patients of the study are followed up 12 months after inclusion into the study.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Iscador Qu Spzial (IQuS)
Primary outcome measure	Overall survival rate, followed up after inclusion at months 1, 2, 3, 6, 9, and 12.
Secondary outcome measures	Quality of life questionnaire, measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30), followed up after inclusion at months 1, 2, 3, 6, 9, and 12.
Overall study start date	01/01/2009
Overall study end date	31/12/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	434
Total final enrolment	220
Participant inclusion criteria	1. Patients with diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas, and, if easily accessible, histo- or cytologically confirmed 2. Aged greater than or equal to 18 years at study enrolment, either sex 3. Written informed consent must be given voluntarily 4. Patients not eligible for gemcitabine 5. Leucocytes greater than 3000/mm^3 6. Thrombocytes greater than 100,000/mm^3 7. Serum creatinine less than 2 mg % 8. Serum glutamic oxaloacetic transaminase (SGOT) less than 3.5-fold upper institutional limit (liver metastasis: five-fold upper institutional limit) 9. Serum glutamic pyruvic transaminase (SGPT) less than 3.5-fold upper institutional limit (liver metastasis: five-fold upper institutional limit) 10. Adequate negative pregnancy test and adequate contraception (where appropriate)
Participant exclusion criteria	1. Pregnancy or breastfeeding 2. Terminally ill patients (life expectancy less than 4 weeks) 3. Significant weight loss (less than 20% body weight in the preceding 6 weeks) 4. Current use of immunostimulant or immuno-suppressive agents except therapeuticals within the routinely administered standard therapy "best supportive care" 5. Current use of investigational agents or participation in a clinical study during the last 4 weeks 6. Clinically significant unrelated systemic illness 7. Co-morbidity with one of the following: 7.1. Diabetes mellitus 7.2. Active tuberculosis 7.3. Active thyroid hyperfunction 7.4. Cancer 7.5. Human immunodeficiency virus (HIV)-infection/acquired immune deficiency syndrome (AIDS) 7.6. Other severe systemic diseases as cardiac insufficiency, parasitosis or Crohn's disease 7.7. Acute inflammatory diseases with body temperature greater than 38°C 8. Drug abuse, alcohol abuse, methadone treatment 9. Known hypersensitivity to mistletoe-containing products 10. Second primary malignancy 11. Known brain metastasis
Recruitment start date	01/01/2009
Recruitment end date	31/12/2014

Locations

Countries of recruitment

Germany
Serbia

Study participating centre

Zechenweg 6

Freiburg
79111
Germany

Sponsor information

Society for Cancer Research (Verein fuer Krebsforschung) (Switzerland)
Research organisation

Kirschweg 9
Arlesheim
4144
Switzerland

Website	http://www.hiscia.ch/
"ROR"	https://ror.org/045jyg234

Funders

Funder type

Research organisation

Society for Cancer Research (Verein fuer Krebsforschung) (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	21/07/2014	30/12/2020	Yes	No

Editorial Notes

30/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.