scholarly journals A Phase II Multicenter Trial on High-Dose Vitamin D Supplementation for the Correction of Vitamin D Insufficiency in Patients with Breast Cancer Receiving Adjuvant Chemotherapy

Nutrients ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 4429
Author(s):  
Elodie Chartron ◽  
Nelly Firmin ◽  
Célia Touraine ◽  
Angélique Chapelle ◽  
Eric Legouffe ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Vitamin D ◽  
Adjuvant Chemotherapy ◽  
Phase Ii ◽  
Predictive Biomarkers ◽  
Vitamin D Supplementation ◽  
High Dose ◽  
Clinical Factor ◽  
Rapid Reduction ◽  
Dose Oral

Breast cancer (BC) treatments induce vitamin D (VD) insufficiency and bone metabolism changes, resulting in osteoporosis and skeletal morbidity risk. We report the results of a bicentric phase II trial (ClinicalTrials.gov Identifier: NCT04091178) on the safety and efficacy of high-dose oral VD supplementation for VD deficiency correction in 44 patients with early BC treated with adjuvant chemotherapies. Patients received one dose of 100,000 IU 25-OH VD every 3 weeks from day 1 of cycle 1 to day 1 of cycle 5. The primary endpoint was the percentage of patients achieving serum 25-OH VD concentration normalization on day 1 of cycle 6 (D1C6). Secondary endpoints were safety, VD and calcium parameters at baseline and during chemotherapy, and identification of predictive biomarkers of VD normalization on D1C6. On D1C6, 21 patients (47.7%, 95% CI: 33.0–62.8) achieved VD normalization. No VD-related clinical toxicity was reported. However, 13 patients (29.5%) presented asymptomatic grade 1 hypercalciuria, leading to interruption of the high-dose oral VD supplementation in 10, followed by a rapid reduction in serum VD concentration. No baseline clinical factor was predictive of VD normalization on D1C6. This high-dose VD supplementation appears safe and efficient in patients with early BC receiving adjuvant chemotherapy.

scholarly journals High Prevalence of Vitamin D Deficiency Despite Supplementation in Premenopausal Women With Breast Cancer Undergoing Adjuvant Chemotherapy

2009 ◽  
Vol 27 (13) ◽  
pp. 2151-2156 ◽  
Author(s):  
Katherine D. Crew ◽  
Elizabeth Shane ◽  
Serge Cremers ◽  
Donald J. McMahon ◽  
Dinaz Irani ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Vitamin D ◽  
Black Women ◽  
Adjuvant Chemotherapy ◽  
Vitamin D Deficiency ◽  
White Women ◽  
Premenopausal Women ◽  
Vitamin D Supplementation ◽  
Mineral Density ◽  
Vitamin D Levels

Purpose Vitamin D deficiency is associated with increased breast cancer risk and decreased breast cancer survival. The purpose of this study was to determine the prevalence of vitamin D deficiency, as measured by serum 25-hydroxyvitamin D (25-OHD), in premenopausal women at initiation of adjuvant chemotherapy for breast cancer and after 1 year of vitamin D supplementation. Patients and Methods The study included 103 premenopausal women from the northeastern United States with stages I to III breast cancer who received adjuvant chemotherapy and participated in a 1-year zoledronate intervention trial. All patients were prescribed vitamin D3 (cholecalciferol) 400 IU and calcium carbonate 1,000 mg daily. At baseline and at 6 and 12 months, bone mineral density (BMD) measurements were obtained and blood was collected and analyzed in batches for serum 25-OHD. Vitamin D deficiency was defined as serum 25-OHD less than 20 ng/mL, insufficiency as 20 to 29 ng/mL, and sufficiency as 30 ng/mL or greater. Results At baseline, 74% of women were vitamin D deficient (median, 17 ng/mL). Vitamin D deficiency was slightly less common in white women (66%) compared with black (80%) and Hispanic (84%) women. After vitamin D supplementation for 1 year, less than 15% of white and Hispanic women, and no black women, achieved sufficient 25-OHD levels. Vitamin D levels did not correlate with baseline BMD and were not altered by chemotherapy or bisphosphonate use. Conclusion Vitamin D deficiency is highly prevalent in women with breast cancer. The current recommended dietary allowance of vitamin D is too low to increase serum 25-OHD greater than 30 ng/mL. Optimal dosing for bone health and, possibly, improved survival has yet to be determined.

Improved Clinical Outcomes Associated With Vitamin D Supplementation During Adjuvant Chemotherapy in Patients With HER2+ Nonmetastatic Breast Cancer

2015 ◽  
Vol 15 (1) ◽  
pp. e1-e11 ◽  
Author(s):  
Simon B. Zeichner ◽  
Tulay Koru-Sengul ◽  
Nikesh Shah ◽  
Qingyun Liu ◽  
Nathan J. Markward ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Vitamin D ◽  
Adjuvant Chemotherapy ◽  
Clinical Outcomes ◽  
Vitamin D Supplementation

scholarly journals Serum and Gene Expression Profile of Cytokines Following Combination of Yoga Training and Vitamin D Supplementation in Breast Cancer Survivors

2021 ◽  
Author(s):  
Mehdi Naderi ◽  
Hajar Kordestani ◽  
Zahra Sahebi ◽  
Vahid Khedmati-zareh ◽  
Sadegh Amani-Shalamzari ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Vitamin D ◽  
Cancer Survivors ◽  
Breast Cancer Survivors ◽  
Handgrip Strength ◽  
Interleukin 10 ◽  
Vitamin D Supplementation ◽  
High Dose ◽  
Fat Percentage ◽  
Tnf Α

Abstract Background This study aimed to examine the effect of a combination of yoga training with high vitamin D dose supplementation on expression and systemic levels of inflammatory cytokines and psychophysical status of breast cancer survivors. Methods Thirty volunteered breast cancer survivors (48 ± 8 yrs.) were randomly allocated to a high dose (4000 IU) of vitamin D supplementation (HD) group (n = 10), yoga with a high dose of vitamin D (YHD) group (n = 10), and yoga with a low dose (2000 IU) of vitamin D (YLD) group (n = 10). Participants performed the Hatha yoga style for 12 weeks, twice a week. Blood samples, quality of life (Qol) questionnaire, and physical performance tests were taken before and after the intervention Results Body fat percentage (ηp2 = 0.36), handgrip strength (ηp2 = 0.41), and Qol indicators include global health (ηp2 = 0.54), functional scales (ηp2 = 0.49), and symptoms scales (ηp2 = 0.50) were significantly improved in the both YHD and YLD groups compared to the HD group (p < 0.05). Also, interleukin-10 (IL-10) levels were markedly increased in the Y-HVD group compared to the Y-LVD and HVD groups. Moreover, there were significant decreases in tumor necrosis factor-α (TNF-α) and interleukin-6 levels in the Y-HVD group after the intervention. The anti-inflammatory index (IL-10/TNF-α) was significantly increased in both the yoga groups (P < 0.05). Conclusion Yoga promotes physical and psychological fitness and, in combination with a high dose of vitamin D, improves the cytokine profile, which can effectively manage the side effects associated with cancer.

A phase II RCT of high-dose vitamin D supplementation and exercise for cancer treatment-induced bone loss in breast cancer patients on aromatase inhibitors.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 11500-11500
Author(s):  
Luke Joseph Peppone ◽  
Jennifer E Reschke ◽  
Michelle Christine Janelsins ◽  
Julia Ellen Inglis ◽  
Karen Michelle Mustian ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Vitamin D ◽  
Bone Loss ◽  
Cancer Treatment ◽  
Cancer Patients ◽  
Phase Ii ◽  
Aromatase Inhibitors ◽  
High Dose ◽  
Breast Cancer Patients ◽  
Hip Bmd

11500 Background: Cancer-treatment-induced bone loss (CTIBL) is a side effect of aromatase inhibitors (AIs) and can result in osteoporotic fractures. Vitamin D (VITD) protects against postmenopausal bone loss but it is unclear if the recommended daily allowance (RDA: 600 IU/day) of VITD is sufficient to prevent CTIBL. This phase II RCT aimed to assess the feasibility, safety, and preliminary efficacy of high-dose VITD (with and without exercise) on bone mineral density (BMD) compared to the RDA. Methods: Non-metastatic breast cancer patients starting AIs with low VITD (<32 ng/ml) were randomized 1:1:1 into 3 arms: 1) placebo 2) high-dose VITD (50,000 IU/week) or 3) high-dose VITD + Exercise for Cancer Patients (EXCAP): a home-based, personalized walking and resistance band training program for 24 weeks. All subjects received the RDA of VITD 600 IU/day. Serum VITD and calcium levels were assessed at baseline, weeks 6, 12, 18, and 24. BMD was assessed at the hip via DXA at baseline and week 24. Results: Of the 116 subjects randomized (mean age = 60; 94% white; mean baseline VITD = 24.6 ng/mL), 90 provided fully evaluable data. Compliance (≥ 80% of instructed doses) exceeded 95% in all 3 arms with no between-group difference. ANCOVA showed significant differences between groups on final VITD levels (high-dose = 63.6 vs high-dose + EXCAP = 60.3 vs placebo = 32.0 ng/mL; p<0.001) without severe calcium toxicities, as indicated by final calcium level (high-dose = 9.4 vs high-dose + EXCAP = 9.5 vs placebo = 9.4 ng/mL; p = 0.78). The placebo group lost a significant amount of hip BMD (−1.7%; p < 0.01) while hip BMD was maintained in the high-dose (−0.1%; p = 0.77) and high-dose + EXCAP (−0.2%; p = 0.74) resulting in significant between-group differences for high-dose + EXCAP vs placebo (p = 0.04) and high-dose vs placebo (p = 0.05). Conclusions: This is one of the first studies to show our novel high-dose VITD intervention, with and without exercise, significantly reduced hip BMD loss in breast cancer patients on AIs. Moreover, high-dose VITD supplementation is safe and feasible in this population. A phase III RCT is needed to confirm these findings. Funding: K07CA168911. Clinical trial information: NCT01419730.

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