scholarly journals Efficacy of mistletoe extract as a complement to standard treatment in advanced pancreatic cancer: study protocol for a multi-centre, parallel group, double-blind, randomised controlled clinical trial (MISTRAL)

2020 ◽  
Author(s):  
Kathrin Wode ◽  
Johanna Hök Nordberg ◽  
Gunver Sophia Kienle ◽  
Nils Elander ◽  
Britt-Marie Bernhardson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Overall Survival ◽  
Cancer Patients ◽  
Advanced Pancreatic Cancer ◽  
Health Related Quality ◽  
Mistletoe Extract ◽  
Related Quality ◽  
Health Related

Abstract 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 18 treatment (palliative chemotherapy or best supportive care) in advanced pancreatic cancer patients with 19 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 0.01mg to 20mg three times per week for nine months. Stratification is performed for site and palliative chemotherapy. Main inclusion criteria are advanced pancreatic cancer and Eastern Cooperative Oncology Group performance status zero to two; main exclusion criteria are life expectancy less than four 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 19 January 2016, https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-004552-64/SE

scholarly journals 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 ◽  
Vol 21 (1) ◽  
Author(s):  
Kathrin Wode ◽  
Johanna Hök Nordberg ◽  
Gunver S. Kienle ◽  
Nils O. Elander ◽  
Britt-Marie Bernhardson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Overall Survival ◽  
Standard Treatment ◽  
Advanced Pancreatic Cancer ◽  
Health Related Quality ◽  
Mistletoe Extract ◽  
Related Quality ◽  
Health Related

Abstract 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.

Relationships among health-related quality of life indicators in cancer patients: A pooled study of baseline EORTC QLQ-C30 data from 6,739 patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9612-9612
Author(s):  
F. Martinelli ◽  
C. Quinten ◽  
C. Coens ◽  
H. Flechtner ◽  
C. Gotay ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Cancer Patients ◽  
The Other ◽  
Health Related Quality ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq

9612 Background: Cancer patients frequently experience multiple and co-occuring problems due to their illness and therapies. Clusters are defined as groups of two or more Health-Related Quality of Life (HRQoL) indicators that occur concurrently and may or may not have a common related cause. The objective of this meta-analysis was to identify how HRQoL indicators cluster among cancer patients. Methods: Retrospective pooling of 29 European Organisation for Research and Treatment of Cancer (EORTC) randomized clinical trials, among 10 cancer sites, yielded baseline EORTC QLQ-C30 HRQoL data for a total of 6739 patients. A cluster analysis was performed to identify clusters among the 15 HRQoL scales, via Ward's method. Cronbach's alpha coefficient (α) was used to measure internal consistency. Dendrograms of the HRQoL indicators were plotted for the overall data and for each cancer site. Results: Three main clusters emerged from the pooled dataset: a physical function-related cluster, consisting of physical and role functioning, fatigue and pain (α = 0.83); a psychological function-related cluster, consisting of emotional and cognitive functioning and insomnia (α = 0.64); and a gastrointestinal cluster, consisting of nausea and vomiting and appetite loss (α = 0.68). The same clusters were found in patients with metastatic and non-metastatic disease. The gastrointestinal cluster was reproduced in all 10 cancer sites. We found that pain was not correlated with the other variables of the physical function cluster for patients with brain, colorectal or pancreatic cancer. For the psychological component cluster, cognitive functioning was not correlated with the other variables of the cluster for breast or pancreatic cancer patients, while insomnia was found not to be correlated with the other variables of the cluster for prostate cancer patients. Conclusions: This study shows that relationships among HRQoL indicators exist and that three major constructs can be found: a physical, a psychological and a gastrointestinal component. Understanding these relationships may aid diagnostic criteria, and assessment, management, and prioritization of symptom care. No significant financial relationships to disclose.

scholarly journals Exploring the relationship among dispositional optimism, health-related quality of life, and CIPN severity among colorectal cancer patients with chronic peripheral neuropathy

2021 ◽  
Author(s):  
Hester.R. Trompetter ◽  
Cynthia S. Bonhof ◽  
Lonneke V. van de Poll-Franse ◽  
Gerard Vreugdenhil ◽  
Floortje Mols
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Peripheral Neuropathy ◽  
Cancer Patients ◽  
Anxiety Symptoms ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

Abstract Purpose Chemotherapy-induced peripheral neuropathy ((CI)PN) becomes chronic in 30% of cancer patients. Knowledge of predictors of chronic (CI)PN and related impairments in health-related quality of life (HRQoL) is lacking. We examined the role of optimism in chronic (CI)PN severity and associated HRQoL in colorectal cancer (CRC) patients up to two years after diagnosis. Methods CRC patients from a prospective cohort study participated, with sensory peripheral neuropathy (SPN) 1 year after diagnosis (n = 142). Multivariable regression analyses examined the cross-sectional association between optimism (measured by the LOT-R) and SPN severity/HRQoL (measured by the EORTC QLQ-CIPN20 and QLQ-C30), as well as the prospective association in a subsample that completed measures 2 years after diagnosis and still experienced SPN (n = 86). Results At 1-year follow-up, higher optimism was associated with better global HRQoL, and better physical, role, emotional, cognitive, and social functioning (all p < .01). Optimism at year one was also prospectively associated with better global HRQoL (p < .05), and emotional and cognitive functioning at 2-year follow-up (both p < .01). Optimism was not related to self-reported SPN severity. Significant associations were retained when controlling for demographic/clinical variables, and became non-significant after controlling for depressive and anxiety symptoms. Conclusions Optimism and depressive and anxiety symptoms are associated with HRQoL in CRC patients with chronic (CI)PN. Future research may illuminate the mechanisms that these factors share, like the use of (non)adaptive coping styles such as avoidance and acceptance that may inform the design of targeted interventions to help patients to adapt to chronic (CI)PN.

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