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)
Autor: | Per Fransson, Johanna Hök Nordberg, Lena Sharp, Roger Henriksson, Nils O. Elander, Gunver S. Kienle, Kathrin Wode, B. Sunde, Britt-Marie Bernhardson |
---|---|
Rok vydání: | 2020 |
Předmět: |
Quality of life
medicine.medical_specialty Palliative care Pancreatic neoplasms Medicine (miscellaneous) Placebo law.invention Study Protocol 03 medical and health sciences 0302 clinical medicine Mistletoe extract Double-Blind Method Randomized controlled trial law Neoplasms Internal medicine Pancreatic cancer medicine Humans Multicenter Studies as Topic Pharmacology (medical) Prospective Studies 030212 general & internal medicine Mistletoe Complementary therapies Clinical trial Randomised controlled trial Randomized Controlled Trials as Topic Cancer och onkologi lcsh:R5-920 Plant Extracts business.industry Kirurgi Standard treatment medicine.disease Cross-Sectional Studies Treatment Outcome Cancer and Oncology 030220 oncology & carcinogenesis Surgery lcsh:Medicine (General) business |
Zdroj: | Trials Trials, Vol 21, Iss 1, Pp 1-17 (2020) |
ISSN: | 1745-6215 2014-0045 |
Popis: | Background Most pancreatic cancer patients present with advanced stage at diagnosis with extremely short expected survival and few treatment options. A multimodal palliative approach is necessary for symptom relief and optimisation of health-related quality of life. In a recent open-label trial of mistletoe extract for advanced pancreatic cancer patients not eligible for chemotherapy, promising results on improved overall survival and better health-related quality of life were reported. The objective of the present study is to assess the value of mistletoe extract as a complement to standard treatment (palliative chemotherapy or best supportive care) in advanced pancreatic cancer patients with regard to overall survival and health-related quality of life. Methods The trial is prospective, randomised, double-blind, multicentre, parallel group and placebo-controlled. In total, 290 participants are randomly assigned to placebo or mistletoe extract given subcutaneously in increasing dosage from 0.01 to 20 mg three times per week for 9 months. Stratification is performed for site and palliative chemotherapy. Main inclusion criteria are advanced pancreatic cancer and Eastern Cooperative Oncology Group performance status 0 to 2; main exclusion criteria are life expectancy less than 4 weeks and neuroendocrine tumour of the pancreas. Two ancillary studies on sub-sets of participants are nested in the trial: a biomarker study collecting blood samples and a cross-sectional qualitative study with semi-structured face-to-face interviews. Discussion To our knowledge, this is the first placebo-controlled randomised trial assessing the impact of mistletoe extract as a complement to standard treatment on overall survival and health-related quality of life in patients with advanced pancreatic cancer. The presented trial with its two nested ancillary studies exploring biomarkers and patient experiences is expected to give new insights into the treatment of advanced pancreatic cancer. Trial registration EU Clinical Trial Register, EudraCT Number 2014-004552-64. Registered on 19 January 2016. ClinicalTrials.gov NCT02948309. Registered on 28 October 2016. |
Databáze: | OpenAIRE |
Externí odkaz: |