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)

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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)

Wode, Kathrin (författare): Umeå universitet,Onkologi,Institutionen för omvårdnad,Umea Univ, Sweden; Karolinska Univ Hosp, Sweden; Reg Canc Ctr Stockholm Gotland, Sweden

Nordberg, Johanna Hoek (författare): Karolinska Institutet

Kienle, Gunver S. (författare): Univ Freiburg, Germany; Univ Witten Herdecke, Germany

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Elander, Nils, 1980- (författare): Linköpings universitet,Avdelningen för kirurgi, ortopedi och onkologi,Medicinska fakulteten,Region Östergötland, Onkologiska kliniken US

Bernhardson, Britt-Marie (författare): Karolinska Institutet

Sunde, Berit (författare): Karolinska Institutet,Umeå universitet,Institutionen för omvårdnad,Umea Univ, Sweden; Karolinska Univ Hosp, Sweden; Karolinska Inst, Sweden

Sharp, Lena (författare): Karolinska Institutet

Henriksson, Roger (författare): Umeå universitet,Onkologi,Umea Univ, Sweden; Norrland Univ Hosp, Sweden

Fransson, Per (författare): Umeå universitet,Institutionen för omvårdnad,Umea Univ, Sweden; Norrland Univ Hosp, Sweden

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2020-09-11
2020
Engelska.
Ingår i: Trials. - : BioMed Central. - 1745-6215. ; 21:1

Relaterad länk:: https://doi.org/10.1...; visa fler...; https://umu.diva-por... (primary) (Raw object); https://trialsjourna...; https://liu.diva-por... (primary) (Raw object); https://urn.kb.se/re...; https://doi.org/10.1...; https://urn.kb.se/re...; http://kipublication...; visa färre...

Tidskriftsartikel (refereegranskat)

Abstract Ämnesord

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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.

Ämnesord

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

Nyckelord

Neoplasms
Pancreatic neoplasms
Mistletoe
Complementary therapies
Palliative care
Quality of life
Clinical trial
Randomised controlled trial

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Av författaren/redakt...: Wode, Kathrin; Nordberg, Johann ...; Kienle, Gunver S ...; Elander, Nils, 1 ...; Bernhardson, Bri ...; Sunde, Berit; visa fler...; Sharp, Lena; Henriksson, Roge ...; Fransson, Per; visa färre...

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MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Cancer och onkol ...

MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Kirurgi

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Av lärosätet: Umeå universitet; Linköpings universitet; Karolinska Institutet

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