Efficacy and Safety of Mistletoe Extract in the Palliative Therapy of Patients Suffering from Pancreatic Cancer (PALM-Pan)

Phase 1

• Conditions: ocally advanced or metastatic adenocarcinoma of the pancreas (UICC stadium III or IV); MedDRA version: 21.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002386-30-BG
• Lead Sponsor: Verein für Krebsforschung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-16
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

1. Patients with diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas (UICC stadium III or IV), histologically confirmed if easily accessible
2. Age between 18 and 90 years at study enrolment, legal competence
3. Voluntarily given written informed consent in advance of any study-specific procedure
4. No pre-treatment with mistletoe extracts
5. No option for surgical resection or radiation in curative intent at the time of inclusion
6. Adequate negative pregnancy test and adequate contraception for women of child-bearing age
7. Scheduled Gemcitabine mono- or Gemcitabine-based combination chemotherapy starting within the next 4 weeks but only after baseline visit
8. Adequate bone marrow function, assessed by laboratory values (existing results not older than 7 days may be used):
8.1 Leucocyte count = 3000 / mm3
8.2 Neutrophil count = 1500 / mm3
8.3 Platelet count = 100.000 / mm3
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 290
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 290

Exclusion Criteria

1. Pregnancy or breastfeeding
2. Terminally ill patients (life expectancy less than 4 weeks)
3. Previous chemotherapy, other systemic therapy or radiotherapy of the current cancer disease
4. Significant weight loss (= 20% body weight in the preceding 6 weeks)
5. Current use of immunostimulant or immunosuppressive agents except therapeutics within the routinely administered standard therapy (e.g. corticosteroids for anti-emesis)
6. Current use of any investigational agent or participation in a clinical trial during the last 4 weeks
7. Drug abuse, alcohol abuse, methadone treatment
8. Second primary malignancy in the last 5 years
9. Known intracranial and spinal tumours and/or metastases
10. Clinically significant concomitant disease critically influencing the ability of the patient to protocol adequate behaviour
11. Co-morbidity with one of the following: chronic granulomatous diseases (incl. Tbc), hyperthyroidism with tachycardia, HIV infection/AIDS, other severe systemic diseases such as cardiac insufficienc (NYHA Stadium III - IV), parasitosis or Crohn's disease, acute inflammatory diseases with body temperature > 38°C, and other high febrile or autoimmune diseases
12. Assured allergy to mistletoe-containing products.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the overall survival and the fatigue symptoms of patients who suffer from advanced pancreatic cancer and who will receive additive palliative therapy with mistletoe extract (ME). ;Secondary Objective: To determine the quality of life and the extent of pain and neutropenia as well as the compatibility of chemotherapy with additive palliative mistletoe therapy.;Primary end point(s): - Overall Survival: time from randomization to death for any reason<br>- Fatigue according to FACIT-FATIGUE, assessed every four weeks;Timepoint(s) of evaluation of this end point: After completion of study and closure of data base.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Time to definitive deterioration of the Physical Functioning Scale of the EORTC QLQ-C30 by 10 units as assessed by a weekly questionnaire or to death for any reason, whichever occurs first<br>- QoL dimensions of the EORTC QLQ-C30 Global Health, Role Functioning, Emotional Functioning, Social Functioning, Cognitive Functioning, Physical Functioning, Nausea/Vomiting, Pain, Insomnia and Appetite Loss, assessed at every study visit except the phone visit<br>- pancreatic cancer-specific pain symptoms, assessed by a weekly questionnaire<br>- Body weight weekly<br>- Rates of moderate and severe/life-threatening neutropenia:<br>CTC II (<1500-1000/mm3), CTC III (<1000-500/mm3) / CTC IV (<500/mm3)<br>- Frequency of other chemotherapy-induced adverse events.;Timepoint(s) of evaluation of this end point: After completion of study and closure of data base.