‘Palliative-D’—Vitamin D Supplementation to Palliative Cancer Patients: A Double Blind, Randomized Placebo-Controlled Multicenter Trial
1
Department of Neurobiology, Care Sciences and Society (NVS), Division of Clinical Geriatrics, Karolinska Institutet, SE-141 83 Huddinge, Sweden
2
ASIH Stockholm Södra, Palliative Home Care and Hospice Ward, SE-125 59 Älvsjö, Sweden
3
Stockholms Sjukhem, Palliative Medicine, SE-112 19 Stockholm, Sweden
4
Department of Environmental Medicine, Division of Biostatistics, Karolinska Institutet, SE-171 77 Stockholm, Sweden
5
Department of Surgery, Breast Centre, Capio St Gorans Hospital, SE-112 19 Stockholm, Sweden
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Department of Oncology-Pathology, Karolinska Institutet, SE-171 77 Stockholm, Sweden
7
Department of Laboratory Medicine, Division of Clinical Microbiology, Karolinska Institutet, SE-141 86 Stockholm, Sweden
8
Department of Infectious Diseases, Immunodeficiency Unit, Karolinska University Hospital, SE-141 86 Stockholm, Sweden
*
Author to whom correspondence should be addressed.
Academic Editor: Eduardo Bruera
Cancers 2021, 13(15), 3707; https://doi.org/10.3390/cancers13153707
Received: 4 July 2021
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Revised: 18 July 2021
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Accepted: 21 July 2021
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Published: 23 July 2021
Simple Summary
In this study, the effect of vitamin D supplementation on pain, infections, fatigue and quality of life in patients with advanced cancer with verified vitamin D deficiency was studied. To this end, a randomized controlled trial, ‘Palliative-D’, was conducted, comparing the effect of 4000 IU vitamin D3/day for 12 weeks to placebo in cancer patients admitted to palliative care. Pain was assessed as change in opioid dose and infections measured as days on antibiotics. Vitamin D-supplemented patients increased their opioid doses at a significantly slower rate than patients receiving placebo, i.e., 0.56 µg less fentanyl/h per week with vitamin D treatment. Vitamin D reduced self-assessed fatigue but did not affect antibiotic use or self-assessed Quality of life. The treatment was safe and well-tolerated. In conclusion, correction of vitamin D deficiency may have positive effects on pain and fatigue in palliative cancer patients.
The aim of the ‘Palliative-D’ study was to test the hypothesis that correction of vitamin D deficiency reduces opioid use in cancer patients admitted to palliative care. A multicenter randomized, placebo-controlled, double-blind trial in three home-based palliative care facilities in Sweden was performed. Patients with advanced cancer and 25-hydroxyvitamin D < 50 nmol/L were randomized to vitamin D3 4000 IU/day or placebo for 12 weeks. The primary endpoint was the difference of long-acting opioid use (fentanyl ug/h) between the groups during 12 weeks, based on four time points. Secondary outcomes included changes in antibiotic use, fatigue and Quality of Life (QoL). A total of 244 patients were randomized, and 150 patients completed the 12 weeks. The major reason for drop-out was death due to cancer. The vitamin D-group had a significantly smaller increase of opioid doses compared to the placebo-group; beta coefficient −0.56 (p = 0.03), i.e., 0.56 µg less fentanyl/h per week with vitamin D treatment. Vitamin D-reduced fatigue assessed with ESAS was −1.1 points after 12 weeks (p < 0.01). Antibiotic use or QoL did not differ significantly between the groups. The treatment was safe and well-tolerated. In conclusion, correction of vitamin D deficiency may have positive effects on opioid use and fatigue in palliative cancer patients, but only in those with a survival time more than 12 weeks.
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Keywords:
vitamin D; Detremin; cholecalciferol; supplementation; randomized clinical trial; placebo; palliative; cancer; fatigue; quality of life; antibiotics; ESAS; EORTC QLQ-C15-PAL
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MDPI and ACS Style
Helde Frankling, M.; Klasson, C.; Sandberg, C.; Nordström, M.; Warnqvist, A.; Bergqvist, J.; Bergman, P.; Björkhem-Bergman, L. ‘Palliative-D’—Vitamin D Supplementation to Palliative Cancer Patients: A Double Blind, Randomized Placebo-Controlled Multicenter Trial. Cancers 2021, 13, 3707. https://doi.org/10.3390/cancers13153707
AMA Style
Helde Frankling M, Klasson C, Sandberg C, Nordström M, Warnqvist A, Bergqvist J, Bergman P, Björkhem-Bergman L. ‘Palliative-D’—Vitamin D Supplementation to Palliative Cancer Patients: A Double Blind, Randomized Placebo-Controlled Multicenter Trial. Cancers. 2021; 13(15):3707. https://doi.org/10.3390/cancers13153707
Chicago/Turabian StyleHelde Frankling, Maria, Caritha Klasson, Carina Sandberg, Marie Nordström, Anna Warnqvist, Jenny Bergqvist, Peter Bergman, and Linda Björkhem-Bergman. 2021. "‘Palliative-D’—Vitamin D Supplementation to Palliative Cancer Patients: A Double Blind, Randomized Placebo-Controlled Multicenter Trial" Cancers 13, no. 15: 3707. https://doi.org/10.3390/cancers13153707
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