'Palliative-D'-Vitamin D Supplementation to Palliative Cancer Patients: A Double Blind, Randomized Placebo-Controlled Multicenter Trial

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 D-3/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 mu g 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 mu g 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.

Automated summary

The study investigated the effects of vitamin D supplementation on pain, fatigue, infections, and quality of life in advanced cancer patients with vitamin D deficiency. Results showed that correcting the deficiency may have positive effects on pain and fatigue, but did not significantly impact antibiotic use or quality of life. The treatment was found to be safe and well-tolerated.