Randomized controlled trial of high-dose versus standard-dose vitamin D3 for prevention of aromatase inhibitor-induced arthralgia

Niravath, Polly; Hilsenbeck, Susan G.; Wang, Tao; Jiralerspong, Sao; Nangia, Julie R.; Pavlick, Anne C.; Ademuyiwa, Foluso O.; Frith, Ashley; Ma, Cynthia; Rigden, Caron; Suresh, Rama; Ellis, Matthew J.; Osborne, C. Kent; Rimawi, Mothaffar F.

doi:10.1007/s10549-019-05319-4

Cited by 13 publications

(7 citation statements)

References 14 publications

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“…Both pharmacologic (duloxetine, 17 testosterone, 18 ω3 fatty acids, 19 and vitamin D 20 ) and nonpharmacologic interventions (exercise 21 ) have been studied to treat AI-associated arthralgias with mixed results. Most of these trials did not assess or did not find long-term benefits.…”

Section: Discussionmentioning

confidence: 99%

“…5 Finally, approximately 10% of patients in each of the groups received acupuncture between 24 and 52 weeks, which may have diminished the observed differences between the groups. Treatment effect, 1.17 (95% CI, 0.61-1.73); P < .001 Both pharmacologic (duloxetine, 17 testosterone, 18 ω3 fatty acids, 19 and vitamin D 20 ) and nonpharmacologic interventions (exercise 21 ) have been studied to treat AI-associated arthralgias with mixed results. Most of these trials did not assess or did not find long-term benefits.…”

Section: Discussionmentioning

confidence: 99%

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Comparison of Acupuncture vs Sham Acupuncture or Waiting List Control in the Treatment of Aromatase Inhibitor–Related Joint Pain

et al. 2022

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ImportanceAromatase inhibitors (AIs) have proven efficacy for the treatment of hormone-sensitive breast cancer; however, arthralgias (pain and stiffness) contribute to nonadherence with therapy for more than 50% of patients.ObjectiveTo examine the effect of acupuncture in reducing AI-related joint pain through 52 weeks.Design, Setting, and ParticipantsA randomized clinical trial was conducted at 11 sites in the US from May 1, 2012, to February 29, 2016, with a scheduled final date of follow-up of September 5, 2017, to compare true acupuncture (TA) with sham acupuncture (SA) or waiting list control (WC). Women with early-stage breast cancer were eligible if they were taking an AI and scored 3 or higher on the Brief Pain Inventory Worst Pain (BPI-WP) item (score range, 0-10; higher scores indicate greater pain). Analysis was conducted for data received through May 3, 2021.InterventionsParticipants were randomized 2:1:1 to the TA (n = 110), SA (n = 59), or WC (n = 57) group. The TA and SA protocols were composed of 6 weeks of intervention at 2 sessions per week (12 sessions overall), followed by 6 additional weeks of intervention with 1 session per week. Participants randomized to WC received no intervention. All participants were offered 10 acupuncture sessions to be used between weeks 24 and 52.Main Outcomes and MeasuresIn this long-term evaluation, the primary end point was the 52-week BPI-WP score, compared by study group using linear regression, adjusted for baseline pain and stratification factors.ResultsAmong 226 randomized women (mean [SD] age, 60.7 [8.6] years; 87.7% White; mean [SD] baseline BPI-WP score, 6.7 [1.5]), 191 (84.5%) completed the trial. In a linear regression, 52-week mean BPI-WP scores were 1.08 (95% CI, 0.24-1.91) points lower in the TA compared with the SA group (P = .01) and were 0.99 (95% CI, 0.12-1.86) points lower in the TA compared with the WC group (P = .03). In addition, 52-week BPI pain interference scores were statistically significantly lower in the TA compared with the SA group (difference, 0.58; 95% CI, 0.00-1.16; P = .05). Between 24 and 52 weeks, 12 (13.2%) of TA, 6 (11.3%) of SA, and 5 (10.6%) of WC patients reported receipt of acupuncture.Conclusions and RelevanceIn this randomized clinical trial, women with AI-related joint pain receiving 12 weeks of TA had reduced pain at 52 weeks compared with controls, suggesting long-term benefits of this therapy.Trial RegistrationClinicalTrials.gov Identifier: NCT01535066

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Comparison of Acupuncture vs Sham Acupuncture or Waiting List Control in the Treatment of Aromatase Inhibitor–Related Joint Pain

et al. 2022

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“…The second solution involves vitamin D supplementation during treatment. Clinical observations show that vitamin D administered at high doses helps to overcome these side effects, especially in postmenopausal women with breast cancer who are treated with aromatase inhibitors and usually have vitamin D deficiency [5][6][7][8][9]. Several groups have conducted studies in which postmenopausal women with breast cancer treated with AIs were monitored for their vitamin D status, bone density, and musculoskeletal symptoms before and during the administration of high doses of vitamin D. Almost 90% of patients showed deficient vitamin D levels in serum, low bone density or bone failure, and musculoskeletal symptoms.…”

Section: Introductionmentioning

confidence: 99%

Vitamin D Compounds PRI-2191 and PRI-2205 Enhance Anastrozole Activity in Human Breast Cancer Models

Filip‐Psurska

Psurski

Anisiewicz

et al. 2021

IJMS

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1,25-Dihydroxycholecalciferol, the hormonally active vitamin D3 metabolite, is known to exhibit therapeutic effects against breast cancer, mainly by lowering the expression of estrogen receptors and aromatase activity. Previously, the safety of the vitamin D active metabolite (24R)-1,24-dihydroxycholecalciferol (PRI-2191) and 1,25(OH)2D3 analog PRI-2205 was tested, and the in vitro activity of these analogs against different cancer cell lines was studied. We determined the effect of the two vitamin D compounds on anastrozole (An) activity against breast cancer based on antiproliferative activity, ELISA, flow cytometry, enzyme inhibition potency, PCR, and xenograft study. Both the vitamin D active metabolite and synthetic analog regulated the growth of not only estrogen receptor-positive cells (T47D and MCF-7, in vitro and in vivo), but also hormone-independent cancer cells such as SKBR-3 (HER-2-positive) and MDA-MB-231 (triple-negative), despite their relatively low VDR expression. Combined with An, PRI-2191 and PRI-2205 significantly inhibited the tumor growth of MCF-7 cells. Potentiation of the antitumor activity in combined treatment of MCF-7 tumor-bearing mice is related to the reduced activity of aromatase by both An (enzyme inhibition) and vitamin D compounds (switched off/decreased aromatase gene expression, decreased expression of other genes related to estrogen signaling) and by regulation of the expression of the estrogen receptor ERα and VDR.

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“…As much of the pharmacological (e.g., duloxetine, Henry et al, 2018; testosterone, Cathcart-Rake et al, 2021; ω3 fatty acids, Shen et al, 2018; vitamin D, Niravath et al, 2019) and nonpharmacologic (e.g., exercise, Irwin et al, 2015) literature has been mixed in regard to efficacy, we view the present results as both clinically meaningful and helpful to patients with MSP. In the present study, the largest adjusted mean-between-group difference on BPI-SF severity between the hypnosis and AC groups—occurred at 6 months and was 1.14 points.…”

Section: Discussionmentioning

confidence: 79%

A randomized controlled trial of hypnosis to manage musculoskeletal pain in breast cancer survivors taking aromatase inhibitors.

Montgomery,

Schnur,

Tiersten

et al. 2024

Psychology of Consciousness: Theory, Research, and Practice

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Randomized controlled trial of high-dose versus standard-dose vitamin D3 for prevention of aromatase inhibitor-induced arthralgia

Cited by 13 publications

References 14 publications

Comparison of Acupuncture vs Sham Acupuncture or Waiting List Control in the Treatment of Aromatase Inhibitor–Related Joint Pain

Comparison of Acupuncture vs Sham Acupuncture or Waiting List Control in the Treatment of Aromatase Inhibitor–Related Joint Pain

Vitamin D Compounds PRI-2191 and PRI-2205 Enhance Anastrozole Activity in Human Breast Cancer Models

A randomized controlled trial of hypnosis to manage musculoskeletal pain in breast cancer survivors taking aromatase inhibitors.

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