(ChemotherapyAdvisor) – Women with stage1–3 breast cancer initiating adjuvant letrozole who also took 30,000IU/week of vitamin D3 had decreased adverse quality of life events, according to results of the VITAL trial presented at the 2012 American Society of Clinical Oncology Annual Meeting.

The double-blind, placebo-controlled randomized trial enrolled women with a 25(OH)D level ≤40ng/mL between April 2009 to July 2010, reported Qamar J. Khan, MD, of the University of Kansas Medical Center, Kansas City, KS. Each received letrozole, standard dose vitamin D3 600IU, and calcium 1,200mg/day, and were randomly assigned to 30,000IU oral vitamin D3 weekly (n=80) or matched placebo (n=80) for 24 weeks.

Median age was 61 years; median BMI was 29.8kg/m2, and 43% had received adjuvant chemotherapy. Median 25(OH)D was 25ng/mL at baseline, 32 at 12 weeks, and 31 at 24 weeks in the placebo arm and 22, 53, and 57, respectively, in the vitamin D arm. One patient in the placebo arm developed mild hypercalcemia. There were no serious adverse events (AEs).

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At week 24, a higher proportion of women in the placebo arm (51%) vs. the vitamin D arm (37%) had a protocol defined musculoskeletal event; i.e., worsening of joint pain, disability from joint pain, or discontinuation of letrozole due to musculoskeletal symptoms (P=0.069). A significantly higher proportion of women in the placebo arm (72%) vs. the vitamin D arm (42%) had an adverse QOL event, defined as worsening of pain, disability or fatigue (P=<0.001).

“Vitamin D deficiency is endemic in the United States, and has been linked to cancer development, progression, and poor outcomes. This study demonstrates that high-dose supplementation to correct vitamin D deficiency helps reduce pain and fatigue in women with a history of breast cancer who are on an adjuvant aromatase inhibitor,” said Fadi Braitheh, MD, of the Comprehensive Cancer Centers of Nevada, about this trial.

“This small study indicates women who receive an aromatase inhibitor should discuss receiving high-dose vitamin D with their doctors to prevent fatigue and pain. It is important to note that such high doses of vitamin D must be prescribed by a doctor; over-the-counter vitamin D is not appropriate. And although not addressed in this study, these quality of life benefits could translate into improvement of patient compliance to complete standard five-year adjuvant hormonal treatment, and thus reduce the risk of breast cancer recurrence.”