A prospective study of aromatase inhibitor therapy, vitamin D, C-reactive protein and musculoskeletal symptoms

Helzlsouer, Kathy J.; Gallicchio, Lisa; MacDonald, Ryan; Wood, Bethany; Rushovich, Errol

doi:10.1007/s10549-011-1729-2

Cited by 18 publications

(16 citation statements)

References 28 publications

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“…[44] Similarly, the IBIS-II cancer prevention trial also reported that low serum levels of 25(OH)D did not predict AIMSS in postmenopausal women taking anastrozole. [45]…”

Section: Discussionmentioning

confidence: 99%

Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS)

Shapiro

Adlis

Robien

et al. 2016

Breast Cancer Res Treat

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Purpose To evaluate the efficacy and safety of vitamin D3 at 4,000 IU/day as a treatment option for aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) when compared with the usual care dose of 600 IU D3. Methods Single site randomized, double-blind, phase 3 clinical trial in women with AIMSS comparing change in symptoms, reproductive hormones and AI pharmacokinetics. Postmenopausal women ≥18 years with stage I-IIIA breast cancer, taking AI and experiencing AIMSS (Breast Cancer Prevention Trial Symptom Scale-Musculoskeletal Subscale ≥1.5 (BCPT-MS)) were admitted. Following randomization, 116 patients had a run-in period of 1 month on 600 IU D3, then began the randomized assignment to either 600 IU D3 (n=56) or 4,000 IU D3 (n=57) daily for 6 months. The primary endpoint was change in AIMSS from baseline (after 1 month run-in) on the BCPT-MS (general musculoskeletal pain; joint pain; muscle stiffness; range for each question: 0=not at all to 4=extremely). Results Groups had no statistically significant differences demographically or clinically. There were no discernable differences between the randomly allocated treatment groups at 6 months in measures of AIMSS, pharmacokinetics of anastrozole and letrozole, serum levels of reproductive hormones, or adverse events. Conclusions We found no significant changes in AIMSS measures between women who took 4000 IU D3 daily compared with 600 IU D3. The 4000 IU D3 did not adversely affect reproductive hormone levels or the steady state pharmacokinetics of anastrozole or letrozole. In both groups, serum 25(OH)D remained in the recommended range for bone health (≥30 ng/mL) and safety (<50 ng/mL).

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“…[44] Similarly, the IBIS-II cancer prevention trial also reported that low serum levels of 25(OH)D did not predict AIMSS in postmenopausal women taking anastrozole. [45]…”

Section: Discussionmentioning

confidence: 99%

Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS)

Shapiro

Adlis

Robien

et al. 2016

Breast Cancer Res Treat

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“…Nearly 80% of the JACS cohort were peri or post-menopausal with only 23% of women reporting their last menstrual period within the previous five years (Table 3). Some studies have also linked Vitamin D and other seasonal effects as having a significant role in joint pain development in women with breast cancer [31,39-41]. Only 9% of the cohort reported taking an osteo-enhancing supplement (defined as Vitamin D, Calcium, or Glucosamine) at baseline; fewer than 20 women reported a daily Vitamin D supplement.…”

Section: Resultsmentioning

confidence: 99%

“…Distress may also be caused if women are unable to differentiate between pain due to metastatic bone cancer or to treatment-aggravated musculoskeletal pain [30]. This new musculoskeletal pain is often reported as being moderate or severe and daily tasks cannot be conducted without the use of pain-killers [6,31]. Recent literature on AI-related arthralgia have identified the hands/wrists and feet/ankles as the most likely locations for joint pain and that pain in these joints has a very high impact on functional ability [6,11,19,26].…”

Section: Introductionmentioning

confidence: 99%

The JACS prospective cohort study of newly diagnosed women with breast cancer investigating joint and muscle pain, aches, and stiffness: pain and quality of life after primary surgery and before adjuvant treatment

et al. 2014

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BackgroundBreast cancer affects one in eight UK women during their lifetime: many of these women now receive adjuvant chemotherapy and hormone therapy. Joint and muscle pains, aches, and stiffness are common but the natural history, aetiology and impact of these symptoms are unknown. A cohort study of newly diagnosed women with primary breast cancer was established to explore this. In this paper we present study methods and sample characteristics, describe participants’ experience of musculoskeletal pain at baseline interview, and explore its impact on quality of life.MethodsWomen with non-metastatic breast cancer were recruited following primary surgery into a multi-centre cohort study. They received questionnaires by post five times (baseline, 3, 6 , 9 and 12 months) to investigate prevalence, severity, location and correlates of musculoskeletal pain, and impact on quality-of-life. Pain was measured by the Nordic musculoskeletal questionnaire, the Brief Pain Inventory, and MSK-specific questions, and quality of life by the SF-36 and FACIT scales.Results543 women (mean age 57 years, range 28–87, 64% postmenopausal) were recruited following surgery for primary breast cancer from breast cancer clinics in eight hospitals. Fifteen per cent of the eligible cohort was missed; 28% declined to participate. Joint or muscle aches, pains or stiffness were reported by 69% women with 28% specifically reporting joint pain/aches/stiffness. Quality of life, as measured by the FACT-B and adjusted for age, depression, surgery and analgesic use, is significantly worse in all domains in those with musculoskeletal problems than those without.ConclusionsOur findings highlights the importance of a better understanding of these symptoms and their impact on the lives of women with primary breast cancer so that healthcare professionals are better equipped to support patients and to provide accurate information to inform treatment decisions. Further papers from this study will address these issues.

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“…Standard endocrine therapy for postmenopausal estrogen receptor positive (ER + ) early stage BCa includes the adjuvant use of an aromatase inhibitors ( AI ) to interfere with estrogen production for between 5 and 10 years. [18] The systemic effects of inhibiting estrogen with AIs include accelerated bone loss and osteoporotic fractures[19] Prior research focused on understanding how survivors’ health-related quality of life (HRQOL) is affected by BCa[20], and how endocrine or hormonal therapy impact HRQOL of BCa patients and survivors[21, 22]. The “Arimidex, tamoxifen, alone or in combination” (ATAC) trial analyzed the HRQOL effects of AIs and Tamoxifen as primary adjuvant therapy for postmenopausal women with localized BCa.…”

Section: Introductionmentioning

confidence: 99%

Self-reported oral health and quality of life of postmenopausal breast cancer survivors on aromatase inhibitors and women without cancer diagnoses: a longitudinal analysis

Taichman

Poznak

Inglehart

2016

Support Care Cancer

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Introduction Aromatase inhibitors (AIs) are a well-established component of adjuvant therapy in postmenopausal women with hormone receptor (HR)+ early stage breast cancer (BCa). We explored in an 18-month cohort study whether subjective oral health (OH), subjective periodontal health (PH), and oral health-related quality of life (OHRQoL) of postmenopausal BCa survivors on AIs differ from those of women without cancer diagnoses, and whether saliva flow, OH, PH and OHRQoL are related. Methods Data were collected from 29 postmenopausal BCa survivors on AIs and 29 postmenopausal women without cancer diagnoses. Socio-demographic information, OH, PH, and OHRQoL were collected at baseline and 6, 12 and 18 months later. Unstimulated whole saliva volume per 15 minutes was determined by drooling. Results The two groups did not differ in background characteristics at baseline. Women on AIs had poorer OH (p=.043), PH (p=.04), and OHRQoL (p=.017), and lower saliva flow rate (p<.001) than control respondents. BCa survivors had the poorest PH at the 18 months visit. Xerostomia was correlated with OH at baseline and with OH and PH at 18 months. However, objective saliva flow rate was not correlated with OH or OHRQoL at this visit. Conclusions This study is the first to investigate the effects of AIs on patients’ subjective OH, subjective PH, and OHRQoL. The data suggest that women treated with AIs have worse OH, PH, and OHRQoL than women without cancer diagnoses. Interprofessional care is recommended so that women on AIs receive optimal supportive oral care to assure long-term OH and positive OHRQoL.

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A prospective study of aromatase inhibitor therapy, vitamin D, C-reactive protein and musculoskeletal symptoms

Cited by 18 publications

References 28 publications

Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS)

Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS)

The JACS prospective cohort study of newly diagnosed women with breast cancer investigating joint and muscle pain, aches, and stiffness: pain and quality of life after primary surgery and before adjuvant treatment

Self-reported oral health and quality of life of postmenopausal breast cancer survivors on aromatase inhibitors and women without cancer diagnoses: a longitudinal analysis

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