Mistletoe Extract in Patients With Advanced Pancreatic Cancer: A Double-Blind, Randomized, Placebo-Controlled Tial (MISTRAL).

BACKGROUND: Patients with advanced pancreatic cancer have -limited survival and few treatment options. We studied whether mistletoe extract (ME), in addition to comprehensive oncological treatment and palliative care, prolongs overall survival (OS) and -improves health-related quality of life (HRQoL). METHODS: The double-blind, placebo-controlled MISTRAL trial was conducted in Swedish oncology centers. The main inclusion criteria were advanced exocrine pancreatic cancer and Eastern Cooperative Oncology Group (ECOG) performance status 0-2. The subjects were randomly assigned to ME (n=143) or placebo (n=147) and were stratified by study site and by eligibility (yes/no) for palliative chemotherapy (June 2016-December 2021). ME or placebo was injected subcutaneously three times a week for nine months. The primary endpoint was overall survival (OS); one of the secondary endpoints was the HRQoL dimension global health/QoL (EORTC-QLQ-C30), as assessed at seven time points over nine months. Trial registration: EudraCT 2014-004552-64, NCT02948309. RESULTS: No statistically significant benefit of adding ME to standard treatment was seen with respect to either OS or global health/QoL. The adjusted hazard ratio for OS was 1.13 [0.89; 1.44], with a median survival time of 7.8 and 8.3 months for ME and placebo, respectively. The figures for the HRQoL dimension "global health/QoL" were similar in the two groups (p=0.86). The number, severity, and outcome of the reported adverse events were similar as well, except for more common local skin reactions at ME injection sites (66% vs. 1%). CONCLUSION: ME is unlikely to have a clinically significant effect on OS or the HRQoL dimension global health/QoL when administered in patients with advanced pancreatic cancer in addition to comprehensive cancer care.

Prevalence and predictive factors of complementary medicine use during the first wave of the COVID-19 pandemic of 2020 in the Netherlands.

INTRODUCTION: Major life changing events such as the COVID-19 pandemic may have major impact on one's health and general well-being. This study aimed to determine the prevalence and predictive factors, including gender specific differences, of Complementary Medicine (CM) use (including CM consultations, self-care management and self-help techniques) during the first wave of the COVID-19 pandemic in 2020 in the Netherlands. METHODS: CM use was studied among a random representative sample (n = 1004) of the adult Dutch population using an online survey conducted from 22-27 May 2020. The survey included a modified version of I-CAM-Q and additional questions on demographic characteristics, reasons for CM use, perceived effectiveness and side effects. RESULTS: 68.0% of the participants reported to have used CM (CM consultations (13.3%), self-management strategies (59.4%), self-help techniques (30.0%)). Most frequently reported reason of CM use was to improve general well-being (61.6%), prevention and/or treatment of COVID-19 was only reported by 10%. Perceived effectiveness of CM was high and number of experienced side effects low. Being a women, worried to get infected with COVID-19, higher education and living in northern/ middle region of the Netherlands were predictive factors to use CM. CONCLUSIONS: In the Netherlands, specific groups (e.g. women/ highly educated) use CM, mainly to improve general wellbeing, and seem to benefit of it during the first months of the pandemic. The high perceived effectiveness and low reporting of side effects should encourage medical professionals and policy makers for more openness towards considering CM as being part of an integrative approach to public health in times life changing events occur.

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.

Women's Lived Experiences of Chronic Pain: Faces of Gendered Suffering.

Women are overrepresented in pain rehabilitation. They seem to be more exposed to comorbidity between mental illness and diseases of the musculoskeletal system than men, implying that besides biopsychosocial factors, gender relations and cultural context should be considered. The aim of the study is to understand the lived experience of women with chronic pain from a caring science and gender perspective. Gadamerian philosophical hermeneutics has been used to analyze interviews from 21 women living with chronic pain in Sweden. The hermeneutical process revealed intertwined experiences of overperformance, loneliness, pain, and exhaustion. Women's experience of an overwhelming life situation and the significance of mutual dependency seem to be central to health and suffering in women with chronic pain. We suggest, contemporary health care to acknowledge women's health and suffering in relation to their life situation and prevailing gender roles.

Cancer patients' use of complementary and alternative medicine in Sweden: a cross-sectional study.

BACKGROUND: Access to and advice on Complementary and Alternative Medicine (CAM) are uncommon within Swedish conventional cancer care and little is known about cancer patients' own use of CAM. The aim of this cross-sectional study was to explore Swedish cancer patients´ patterns of CAM use, their experiences and preferences. METHODS: Questionnaires were distributed consecutively to 1297 cancer patients at a university hospital's out-patient oncology units. The response rate was 58% (n = 755). Descriptive statistics were used to analyze the survey data. A logistic regression model was used to investigate the association between CAM use and gender, age and level of education. Open-ended responses were analyzed, using qualitative content analysis. RESULTS: Lifetime CAM use was reported by 34% (n = 256), and 26% (n = 198) used CAM after cancer diagnosis. Being female, younger and having higher education predicted CAM use. Most commonly used methods were natural products including vitamins and minerals and relaxation. Main reasons for CAM use were improvement of physical, general and emotional wellbeing and increasing the body's ability to fight cancer. Satisfaction with CAM usage was generally high. Reported adverse effects were few and mild; 54% of users spent < 50 Euro a month on CAM. One third had discussed their CAM use with cancer care providers. More than half of all participants thought that cancer care providers should be able to discuss (58%) and to consider (54%) use of CAM modalities in cancer care. CONCLUSIONS: Despite limited access and advice within conventional cancer care, one fourth of Swedish cancer patients use CAM. The insufficient patient-provider dialogue diverges with most patients' wish for professional guidance in their decisions and integration of CAM modalities in conventional cancer care. Concurrent and multimodal CAM use implies challenges and possibilities for cancer care that need to be considered.