Randomized trial of vitamin D3 to prevent worsening of musculoskeletal symptoms in women with breast cancer receiving adjuvant letrozole. The VITAL trial

2017 ◽  
Vol 166 (2) ◽  
pp. 491-500 ◽  
Author(s):  
Qamar J. Khan ◽  
Bruce F. Kimler ◽  
Pavan S. Reddy ◽  
Priyanka Sharma ◽  
Jennifer R. Klemp ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Trial ◽  
Vitamin D3 ◽  
Musculoskeletal Symptoms

Randomized trial of vitamin D3 to prevent worsening of musculoskeletal symptoms and fatigue in women with breast cancer starting adjuvant letrozole: The VITAL trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9000-9000 ◽  
Author(s):  
Qamar J. Khan ◽  
Bruce F. Kimler ◽  
Pavan S. Reddy ◽  
Priyanka Sharma ◽  
Jennifer R. Klemp ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Trial ◽  
Aromatase Inhibitors ◽  
Vitamin D3 ◽  
Joint Pain ◽  
Positive Impact ◽  
Standard Dose ◽  
Musculoskeletal Symptoms ◽  
Pain Disability ◽  
The Impact

9000 Background: Musculoskeletal (MS) pain and fatigue are common in women on adjuvant Aromatase Inhibitors (AIs) and lead to reduced compliance. Pilot studies suggest a positive impact of vit D on MS pain and disability from AIs. We conducted a bi-institutional, double blind, placebo controlled randomized trial to study the impact of 30,000 I.U of vit D3 in preventing worsening of MS pain and fatigue in women starting letrozole. Methods: Women with stage I-III breast cancer starting adjuvant AI and a 25(OH)D level of 40 ng/ml or less were eligible. Women with prior renal stones or hypercalcemia were excluded. All subjects received letrozole, plus standard dose vitD3 (600 IU) and calcium (1200 mg) daily, all provided by the study. Women were randomly assigned to 30,000 IU of oral vitD3 wkly (vitD arm) or matched placebos (PL arm) for 24 weeks. The following were assessed at baseline, 12 wks, and 24 wks (end of study): 1) 25OHD levels, 2) symptoms tools (BFI – Brief Fatigue Inventory, HAQII - Health Assessment Questionnaire II, Qualitative Joint Pain (none, mild, moderate, severe), BPI – Brief Pain Inventory) and 3) hand grip strength with a dynamometer. Results: 160 women (80/arm) were enrolled from 4/09 to 7/10. There were no differences between the two arms in demographics/tumor characteristics. Median age was 61, median BMI was 29.8 kg/m2. 43% had adjuvant chemotherapy. Median 25OHD (ng/ml) was 25 at baseline, 32 at 12 wks and 31 at 24 wks in the PL arm and 22, 53 and 57 in vitD arm. One patient in the PL arm developed mild hypercalcemia. There were no SAEs. 147 subjects were evaluable for efficacy. 3 subjects, all in the PL arm discontinued early due to a MS adverse event. At wk 24, a higher proportion of women in PL (51%) vs vitD arm (37%) had a protocol defined MS event (worsening of joint pain, disability from joint pain or discontinuation of Letrozole due to MS symptoms) (p=0.069). A significantly higher proportion of women in PL (72%) vs vitD arm (42%) had an adverse QOL event (worsening of pain, disability or fatigue) (p=<0.001). Conclusions: 30,000 IU/week of vitamin D3 is safe and results in decreased adverse QOL events from adjuvant aromatase inhibitors in women with breast cancer.

Vitamin D levels during and after high-dose vitamin D supplementation in women with early-stage breast cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20561-e20561
Author(s):  
Q. J. Khan ◽  
B. F. Kimler ◽  
P. Sharma ◽  
P. S. Reddy ◽  
S. Baxa ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Vitamin D ◽  
Vitamin D3 ◽  
Early Stage ◽  
Linear Regression Analysis ◽  
Musculoskeletal Symptoms ◽  
High Dose ◽  
25Ohd Level ◽  
Vitamin D Levels ◽  
High Dose Vitamin

e20561 Background: Experts define vitamin D deficiency as a 25-hydroxyvitamin D (25OHD) level of < 20 ng/ml; a level < 32 ng/ml is considered insufficient for bone health and > 40 ng/ml may be associated with optimum musculoskeletal function and reduced risk for breast cancer. We conducted a study to determine the effect of high dose vitamin D3 at 50,000 IU/wk (HD vitD) on musculoskeletal symptoms from adjuvant letrozole in breast cancer patients. We present here the effectiveness of HD vitD in achieving optimum 25OHD levels and the rate of decline of 25OHD levels after 12 weeks of HD vitD. Methods: The cohort included post-menopausal women with early stage hormone receptor positive breast cancer initiating letrozole treatment. Women with baseline 25OHD levels < 40 ng/ml received 12 weeks of HD vitD. 25OHD levels were assessed at 6 and 12 weeks during HD vitD supplementation and at 3 and 6 months after completing HD vitD but while taking maintenance dose of 600–1000 IU of vitamin D3 daily. Results: 40 women that received HD vitD completed the follow-up phase of the study and are included in this analysis. At entry on study, median 25OHD level was 23 ng/ml; 38% of the women had vitD deficiency, 75% had insufficiency, and 93% had 25OHD levels < 40 ng/ml. Six weeks of HD vitD increased median 25OHD level to 60 ng/ml and another 6 weeks increased it further to 66 ng/ml. With only 6 weeks of HD vitD supplementation, 98% of the women achieved a 25OHD level of > 40 ng/ml. Median 25OHD levels 3 and 6 months after completion of HD vitD were 49 and 40 ng/ml, respectively. The median rate of decrease in vitD levels per month was 6.8% of the level at completion of supplementation. Using linear regression analysis, projected changes in 25OHD levels were calculated for each subject. Median extrapolated time to drop to a 25OHD level of < 40 ng/ml was 6.0 months, to <32 ng/ml was 7.8 months, and to <20 ng /ml was 10.6 months. Conclusions: Supplementation with vitD3 at 50,000 IU/week for 6 weeks is sufficient to achieve a 25OHD level of >40 ng/ml in 98% of postmenopausal women with breast cancer on an AI. After 12 weeks of HD vitD, there is a steady decline in 25OHD levels at a rate of about 7% per month despite continuing on 600 to 1000 IU of D3 daily. Thus, standard doses of D3 are not adequate to maintain 25OHD levels achieved by HD vitD. No significant financial relationships to disclose.

A randomized trial of vitamin D3 in aromatase inhibitor-associated musculoskeletal symptoms.

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. 9608-9608 ◽  
Author(s):  
Alice C. Shapiro ◽  
Susan A Adlis ◽  
Shuang Liang ◽  
Kim Robien ◽  
Mark N. Kirstein ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Aromatase Inhibitor ◽  
Vitamin D3 ◽  
Musculoskeletal Symptoms

A randomized trial of exercise versus control for musculoskeletal symptoms from adjuvant anastrozole (A) for postmenopausal early breast cancer (PEBC).

2011 ◽  
Vol 29 (15_suppl) ◽  
pp. 636-636 ◽  
Author(s):  
C. A. Lohrisch ◽  
D. McKenzie ◽  
P. Truong ◽  
D. Jesperson ◽  
K. A. Gelmon ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Trial ◽  
Early Breast Cancer ◽  
Musculoskeletal Symptoms

Inflammatory mediators, exercise, and fatigue in breast cancer survivors: Pilot randomized trial

2013 ◽  
Author(s):  
Laura Q. Rogers ◽  
R. Trammell ◽  
S. Vicari ◽  
P. Hopkins-Price ◽  
A. Spenner ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Survivors ◽  
Randomized Trial ◽  
Inflammatory Mediators ◽  
Breast Cancer Survivors
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