Journal of Clinical Oncology, 2012 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 30, No 15_suppl (May 20 Supplement), 2012: 9097
© 2012 American Society of Clinical Oncology
Dragan Trivanovic, Stjepko Plestina, Renata Dobrilla-Dintinjana, Lorena Honovic, Lems Jerin and Irena Hrstic
General Hospital Pula, Pula, Croatia; University Hospital Centre Zagreb, Zagreb, Croatia; Internal Clinic, Rijeka, Croatia
Background: Fatigue is one of the most common symptoms of patients diagnosed with cancer. Vitamin D deficiency has been associated with an increased risk of mortality in oncology patients. We conducted a prospective vitamin D (cholecalciferol) supplementation study to analyse the response to oral D3 supplementation on fatigue in this population of chemo-naïve patients.
Methods: Eligibility critera included life expectancy 6 months, ECOG PS 0-3, low serum 25-hydroxyvitamin D3 at the time of diagnosis (using cutoff value of 32 ng/mL), and normal serum calcium level. Cancer related fatigue was measured with the Functional Assessment of Cancer Therapy Fatigue module (FACT-F). Patients were randomized to receive oral supplementation with 2,000 IU of Vitamin D3 daily for 3 months with standard cancer treatment or to continue standard treatment without vit D3 supplementation. Primary endpoint was changes in the FACT-F scale. Secondary endpoints was improvement of vitamin D serum levels and safety.
Results: 69 vit D deficient patients enrolled in the this study between November 2009 and November 2011 returned a baseline FACT-F. The mean serum 25(OH)D levels were 18.7 ng/ml (SD = 7.4) at baseline. Patients in experimental arm showed marked improvement from baseline in fatigue (p<0.05) and vitamin D serum levels after 3 months (p<0.001). There were significant difference in fatigue score in patients with experimental arm and control arm after 3 months of treatment (p< 0.001).
Conclusions: Vitamin D supplementation resulted in a significant increase in Fatigue score and serum 25(OH)D levels in vitamin D deficient patients. Fatigue improve rapidly but remain worse in control arm. The safety profile of vitamin D in combination with chemotherapy or BSC was acceptable.
Patients N Vit D change FACT-F change
Baseline 34 13.56 3.8
Controls 35 -0.9 -2.3
- BSC probably is Best Supportive Care
- FACT-F score is apparently 0-52
2,000 IU helped reduce advanced cancer fatigue some, more vitamin D - day 5,000 IU - would probably help much more