Mistletoe extract in patients with advanced pancreatic cancer: a double-blind, randomized, placebo-controlled trial (MISTRAL)

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Mistletoe extract in patients with advanced pancreatic cancer : a double-blind, randomized, placebo-controlled trial (MISTRAL)

Wode, Kathrin, 1968- (författare): Umeå universitet,Onkologi,Department of Neurobiology, Caring Sciences and Society, Karolinska Institutet, Stockholm, Sweden; Regional Cancer Centre Stockholm Gotland, Stockholm, Sweden

Kienle, Gunver Sophia (författare): Center for Complementary Medicine, Department of Medicine II, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany; Institute for Applied Epistemology and Medical Methodology, Witten/Herdecke University (IFAEMM), Freiburg, Germany

Björ, Ove, 1967- (författare): Umeå universitet,Onkologi

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Fransson, Per (författare): Umeå universitet,Institutionen för omvårdnad

Sharp, Lena, PhD (författare): Umeå universitet,Institutionen för omvårdnad,Regional Cancer Centre Stockholm Gotland, Stockholm, Sweden

Elander, Nils O. (författare): Department of Biomedical and Clinical Sciences, Linköping University, Sweden

Bernhardson, Britt-Marie (författare): Department of Neurobiology, Caring Sciences and Society, Karolinska Institutet, Stockholm, Sweden

Johansson, Birgit (författare): Department of Oncology, Västmanlands Hospital, Västerås, Sweden

Edwinsdotter Ardnor, Christina (författare): Umeå universitet,Onkologi

Scheibling, Ursula (författare): Department of Oncology, Ryhov County Hospital, Jönköping, Sweden; Palliative Care Unit, Västerås, Sweden

Hök Nordberg, Johanna (författare): Department of Neurobiology, Caring Sciences and Society, Karolinska Institutet, Stockholm, Sweden; Regional Cancer Centre Stockholm Gotland, Stockholm, Sweden

Henriksson, Roger (författare): Umeå universitet,Onkologi

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Deutscher Arzte-Verlag GmbH, 2024
2024
Engelska.
Ingår i: Deutsches Ärzteblatt International. - : Deutscher Arzte-Verlag GmbH. - 1866-0452. ; 121:11, s. 347-354

Relaterad länk:: https://urn.kb.se/re...; visa fler...; https://doi.org/10.3...; visa färre...

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Abstract Ämnesord

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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, NCT02948309Results: 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.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)

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Av författaren/redakt...: Wode, Kathrin, 1 ...; Kienle, Gunver S ...; Björ, Ove, 1967-; Fransson, Per; Sharp, Lena, PhD; Elander, Nils O.; visa fler...; Bernhardson, Bri ...; Johansson, Birgi ...; Edwinsdotter Ard ...; Scheibling, Ursu ...; Hök Nordberg, Jo ...; Henriksson, Roge ...; visa färre...

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