Abstract
Simple SummaryIn 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.
Highlights
Vitamin D is a steroid hormone that maintains calcium homeostasis and skeletal health [1]
Patients were withdrawn from the study if they developed hypercalcemia, if eGFR dropped below 30 mL/min, if they were prescribed medications that were not allowed according to the study protocol, had poor compliance, could no longer take the study drug, withdrew consent, were lost to follow-up or reported serious or intolerable adverse events
The vitamin D group exhibited a significantly lower degree of fatigue assessed with Edmonton Symptom Assessment Scale (ESAS) compared to the placebo group after 12 weeks; −1.1 point (p < 0.01) (Figure 3)
Summary
Vitamin D is a steroid hormone that maintains calcium homeostasis and skeletal health [1]. Vitamin D reduces cytokine release, dampens inflammatory T-cell responses and has been shown to downregulate prostaglandin synthesis [6,7,8,9] These findings provide a possible mechanistic explanation for effects of vitamin D supplementation regarding infections and pain. A cross-sectional observational study at our palliative care facility revealed that lower levels of 25-OHD were associated with prescription of higher doses of opioids [17]. Based on this observation, we performed a pilot study, where 39 patients with vitamin D deficiency were supplemented with vitamin D3 oil drops (4000 IU/day) for 12 weeks [23]. To test whether these results could be reproduced in a randomized and placebo-controlled setting, we designed the ‘PalliativeD’ study
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