Mistletoe Therapy in Primary and Recurrent Inoperable Pancreatic Cancer

NCT02948309 | Completed Phase 3

• 2 other identifiers: 1310162014-004552-64
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

Primary diagnosis; Relapse

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  OS defined as time from randomization to death for any reason

  End of study (estimated 3 years)

Secondary Outcomes (11)

• Quality of Life questionnaire EORTC QLQ-C30

  At 7 visits during study (9 months)

• Quality of Life questionnaire EORTC PAN -26

  At 7 visits during study (9 months)

• Weight in kilograms, height in meters, BMI in kg/m^2

  At 7 visits during study (9 months)

• Corticosteroid use in milligrams betamethasone per day and indication (appetite, chemotherapy, nausea, pain, general wellbeing, other: specified)

  At 7 visits during study (9 months)

• Number of visits of homecare team per week

  At 7 visits during study (9 months)

Study Arms (2)

Mistletoe extract (Iscador Qu)

EXPERIMENTAL

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

PLACEBO COMPARATOR

isotonic saline solution, subcutaneous use 3 injections/week

Drug: Placebo

Interventions

Mistletoe extract (Iscador Qu) DRUG

1ml subcutaneous injection 3 times/week, dose escalation 0,01mg - 20mg

Also known as: Fermented aqueous extract of Viscum album ssp album (L.)

Mistletoe extract (Iscador Qu)

Placebo DRUG

1ml subcutaneous injection 3 times/week

Also known as: Isotonic saline solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• Age ≥ 18 years
• Inoperable locally advanced or metastatic pancreatic cancer or relapse of pancreatic cancer.
• Primary diagnosis: if histology is not clinically achievable diagnosis is to be confirmed according to local practice sufficient for diagnosis and choice of therapy (such as CA19-9 (=cancer antigen 19-9) and CT).
• Relapse: histology (not required) or diagnosis according to local practice such as clinical signs and/or imaging and/or CA19-9.
• ECOG ( Eastern Cooperative Oncology Group) performance status 0-2 (see table in section 12.14 )
• Adequate negative pregnancy test and adequate contraception (where appropriate)

You may not qualify if:

• Life expectancy less than 4 weeks
• Pregnancy or breastfeeding
• Neuroendocrine tumors of the pancreas (NET)
• Current use of interferon, G-CSF (granulocyte colony-stimulating factor) and thymus preparations
• Symptomatic brain edema due to brain metastases
• Known hypersensitivity to mistletoe-containing products
• Current use of mistletoe extract preparations in any form
• Chronic granulomatous disease or active autoimmune disease or autoimmune disease with immunosuppressive treatment
• Medical, psychiatric, cognitive or other conditions that may compromise the patient´s ability to understand the patient information, give informed consent, comply with the study protocol or complete the study (e.g. needle phobia).

Sponsors & Collaborators

• Karolinska University Hospital: lead
• University of Witten/Herdecke: collaborator
• Karolinska Institutet: collaborator
• Regional Cancer Centre Stockholm Gotland: collaborator
• Stiftelsen Konung Gustaf V:s Jubileumsfond för cancerforskning: collaborator
• Signe & Ane Gyllenbergs Stiftelse: collaborator
• Ekhagastiftelsen: collaborator
• Dagmar Ferbs Minnesfond: collaborator
• Cancerforskningsfonden i Norrland: collaborator
• Immunpathologisches Labor, University Tübingen: collaborator
• The Sjöberg Foundation: collaborator

Study Sites (1)

Kathrin Wode

Stockholm, 14186, Sweden

Location

Related Publications (6)

• Troger W, Galun D, Reif M, Schumann A, Stankovic N, Milicevic M. Quality of life of patients with advanced pancreatic cancer during treatment with mistletoe: a randomized controlled trial. Dtsch Arztebl Int. 2014 Jul 21;111(29-30):493-502, 33 p following 502. doi: 10.3238/arztebl.2014.0493.

  PMID: 25142075 BACKGROUND

• Troger W, Galun D, Reif M, Schumann A, Stankovic N, Milicevic M. Viscum album [L.] extract therapy in patients with locally advanced or metastatic pancreatic cancer: a randomised clinical trial on overall survival. Eur J Cancer. 2013 Dec;49(18):3788-97. doi: 10.1016/j.ejca.2013.06.043. Epub 2013 Jul 24.

  PMID: 23890767 BACKGROUND

• Horneber MA, Bueschel G, Huber R, Linde K, Rostock M. Mistletoe therapy in oncology. Cochrane Database Syst Rev. 2008 Apr 16;2008(2):CD003297. doi: 10.1002/14651858.CD003297.pub2.

  PMID: 18425885 BACKGROUND

• Kienle GS, Glockmann A, Schink M, Kiene H. Viscum album L. extracts in breast and gynaecological cancers: a systematic review of clinical and preclinical research. J Exp Clin Cancer Res. 2009 Jun 11;28(1):79. doi: 10.1186/1756-9966-28-79.

  PMID: 19519890 BACKGROUND

• Wode K, Kienle GS, Bjor O, Fransson P, Sharp L, Elander NO, Bernhardson BM, Johansson B, Edwinsdotter Ardnor C, Scheibling U, Hok Nordberg J, Henriksson R. Mistletoe Extract in Patients With Advanced Pancreatic Cancer: a Double-Blind, Randomized, Placebo-Controlled Tial (MISTRAL). Dtsch Arztebl Int. 2024 May 31;121(11):347-354. doi: 10.3238/arztebl.m2024.0080.

  PMID: 38915151 DERIVED

• Wode K, Hok Nordberg J, Kienle GS, Elander NO, Bernhardson BM, Sunde B, Sharp L, Henriksson R, Fransson P. Efficacy of mistletoe extract as a complement to standard treatment in advanced pancreatic cancer: study protocol for a multicentre, parallel group, double-blind, randomised, placebo-controlled clinical trial (MISTRAL). Trials. 2020 Sep 11;21(1):783. doi: 10.1186/s13063-020-04581-y.

  PMID: 32917288 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Recurrence

Interventions

viscum album peptide

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Annika Bergquist, Ass Prof

  Gastrocentrum Karolinska University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: October 28, 2016
• Study Start: June 1, 2016
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)