Article Text

PDF
Vitamin D supplementation to palliative cancer patients: protocol of a double-blind, randomised controlled trial ‘Palliative-D’
  1. Maria Helde-Frankling1,2,
  2. Jenny Bergqvist3,4,
  3. Caritha Klasson1,
  4. Marie Nordström5,
  5. Jonas Höijer6,
  6. Peter Bergman2 and
  7. Linda Björkhem-Bergman1,2
  1. 1ASIH Stockholm Södra, Långbro Park, Palliative Home Care and Hospice Ward, Älvsjö, Sweden
  2. 2Department of Laboratory Medicine, Division of Clinical Microbiology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden
  3. 3Department of Surgery, Breast Centre, Capio St Görans Hospital, Stockholm, Sweden
  4. 4Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden
  5. 5Stockholms Sjukhem, Palliative Home Care and Hospice Wards, Stockholm, Sweden
  6. 6Unit of Biostatistics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden
  1. Correspondence to Dr Linda Björkhem-Bergman, ASIH Stockholm Södra, Palliative Home Care and Hospice Ward, Bergtallsvägen 12, 125 59 Älvsjö, Sweden; linda.bjorkhem-bergman{at}ki.se

Abstract

Background According to a small pilot study on palliative cancer patients at our ward, vitamin D supplementation had beneficial effects on pain (measured as opioid consumption), infections and quality of life (QoL) without having any significant side effects.

Objective The primary objective of the ‘Palliative-D’ study is to test the hypothesis that vitamin D supplementation for 12 weeks reduces opioid consumption. The secondary objectives are to study if reduction of antibiotic consumption and fatigue as well as improvement in QoL assessments can be observed. Effect on the 25-hydroxy vitamin D (25-OHD) levels in serum after 12 weeks of treatment will be studied, as well as the change in opioid dose in relation to genetic polymorphism in genes involved in the effect and metabolism of vitamin D.

Method A randomised, double-blind placebo-controlled multicentre trial has been designed. The trial will include 254 adult palliative cancer patients with 25-OHD levels <50 nmol/L and a life expectancy of more than 3 months recruited from two advanced palliative home care centres in Stockholm. Included patients will be randomly assigned to 12 weeks of treatment with cholecalciferol (vitamin D3) 4000 IU/day or placebo. The study will start in November 2017 and will finish in December 2019. The study is approved by the Regional Ethical Committee, Dnr2017/405-31/1, by the Swedish Medical Products Agency, EudraCT: 2017-000268-14, and is registered at Clinicaltrial.gov: NCT03038516. The study is financed with research grants from the Swedish Cancer Society and the Stockholm County Council.

  • vitamin D
  • pain
  • opioid
  • infections
  • hospice care
  • quality of life
  • Received 23 August 2017.
  • Revision received 24 August 2017.
  • Accepted 24 August 2017.

Statistics from Altmetric.com

  • Received 23 August 2017.
  • Revision received 24 August 2017.
  • Accepted 24 August 2017.
View Full Text

Footnotes

  • Contributors All authors have contributed to the design, planning, conduction and reporting of the research. MH-F and LB-B has been writing the first draft of the manuscript. All authors have contributed to the final version of the manuscript.

  • Funding This work was financially supported by The Swedish Cancer Society and the regional agreement on training and clinical research (ALF) between Karolinska Institutet and Stockholm County Council.

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval The regional ethical commitee in Stockholm.

  • Provenance and peer review Not commissioned; internally peer reviewed.

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.