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).

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.

Dealing with taste and smell alterations-A qualitative interview study of people treated for lung cancer.

Taste and smell alterations have been recognized as common symptoms in relation to various cancers. However, previous research suggests that patients do not receive sufficient support in managing taste and smell alterations. Therefore, the objective of this study is to investigate how persons with experience from lung cancer-related taste and smell alterations reason about resources and strategies offered and used to manage these symptoms. Data from semi-structured individual interviews with 13 women and four men were analyzed with qualitative content analysis. We used Kleinman's now classic medical anthropological model of local health care systems, consisting of the personal, professional, and folk sector, to interpret and understand how people respond to sickness experiences in their daily lives. By presenting the findings using this model, we demonstrate that most strategies for dealing with taste and smell alterations were undertaken in the personal sector, i.e. in participants' daily lives, on an individual level and in interaction with family, social networks and communities. Taste and smell alterations implied two overarching challenges: 1) adjusting to no longer being able to trust information provided by one's own senses of taste and/or smell, and 2) coming to terms with taste and smell alterations as a part of having lung cancer. Health care professionals' involvement was described as limited, but appeared to fulfil most participants' expectations. However, through provision of normalizing information, practical advice, and to some extent, emotional support, health care professionals had potential to influence strategies and resources used for dealing with taste and smell alterations. With this study, we further the understanding of how people deal with lung cancer-related taste and smell alterations and discuss the role of health care professionals for this process.