Purpose CIPN is a common toxicity associated with chemotherapy, but researchers rarely study its risk factors, fall risk, and prevalence in long-term breast cancer survivors. We aimed to determine CIPN prevalence, risk factors, and association with psychological distress and falls among long-term breast cancer survivors. Methods We conducted cross-sectional analyses among postmenopausal women with a history of stage I–III breast cancer who received taxane-based chemotherapy. Participants reported neuropathic symptoms of tingling/numbness in hands and/or feet on a 0–10 numerical rating scale. We conducted multivariate logistic regression analyses to evaluate risk factors associated with the presence of CIPN and the relationship between CIPN and anxiety, depression, insomnia, and patient-reported falls. Results Among 296 participants, 173 (58.4%) reported CIPN symptoms, 91 (30.7%) rated their symptoms as mild and 82 (27.7%) rated them moderate to severe. Compared with women of normal weight, being obese was associated with increased risk of CIPN, (adjusted OR 1.94, 95% CI: 1.03–3.65). Patients with CIPN reported greater insomnia severity, anxiety, and depression than those without (all p<0.05). Severity of CIPN was associated with higher rates of falls, with 23.8%, 31.9%, and 41.5% in the “no CIPN,” “mild,” and “moderate-to-severe” groups, respectively, experiencing falls (p=0.028). Conclusions The majority of long-term breast cancer survivors who received taxane-based chemotherapy reported CIPN symptoms; obesity was a significant risk factor. Those with CIPN also reported increased psychological distress and falls. Interventions need to target CIPN and comorbid psychological symptoms, and incorporate fall prevention strategies for aging breast cancer survivors.

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BackgroundPremature discontinuation of aromatase inhibitors (AIs) in breast cancer survivors compromises treatment outcomes. We aimed to evaluate whether patient-reported joint pain predicts premature discontinuation of AIs.MethodsWe conducted a retrospective cohort study of postmenopausal women with breast cancer on AIs who had completed a survey about their symptom experience on AIs with specific measurements of joint pain. The primary outcome was premature discontinuation of AIs, defined as stopping the medication prior to the end of prescribed therapy. Multivariate Cox regression modeling was used to identify predictors of premature discontinuation.ResultsAmong 437 patients who met eligibility criteria, 47 (11%) prematurely discontinued AIs an average of 29 months after initiation of therapy. In multivariate analyses, patient-reported worst joint pain score of 4 or greater on the Brief Pain Inventory (BPI) (Hazard Ratio [HR] 2.09, 95% Confidence Interval [CI] 1.14-3.80, P = 0.016) and prior use of tamoxifen (HR 2.01, 95% CI 1.09-3.70, P = 0.026) were significant predictors of premature discontinuation of AIs. The most common reason for premature discontinuation was joint pain (57%) followed by other therapy-related side effects (30%). While providers documented joint pain in charts for 82% of patients with clinically important pain, no quantitative pain assessments were noted, and only 43% provided any plan for pain evaluation or management.ConclusionWorst joint pain of 4 or greater on the BPI predicts premature discontinuation of AI therapy. Clinicians should monitor pain severity with quantitative assessments and provide timely management to promote optimal adherence to AIs.

Background Generalized Anxiety Disorder (GAD) is one of the most common anxiety disorders treated in primary care, yet current therapies have limited efficacy and substantial side effects. Purpose To evaluate long-term chamomile (Matricaria chamomilla L.) use for prevention of GAD symptom relapse. Methods Outpatients from primary care practices and local communities with a primary diagnosis of moderate-to-severe GAD were enrolled for this two-phase study at a large US academic medical center. During Phase 1, eligible participants received 12 weeks of open-label therapy with chamomile pharmaceutical grade extract 1500 mg (500-mg capsule 3 times daily). During Phase 2, treatment responders were randomized to either 26 weeks of continuation chamomile therapy or placebo in a double-blinded, placebo-substitution design. The primary outcome was time to relapse during continuation therapy, analysed using Cox proportional hazards. Secondary outcomes included the proportion who relapsed, treatment-emergent adverse events, and vital sign changes. This study is registered at ClinicalTrials.gov, identifier NCT01072344. Results Between March 1, 2010, and June 30, 2015, we enrolled 179 participants. Of those, 93 (51.9%) were responders and agreed to continue in the double-blind randomized controlled trial. A numerically greater number of placebo-switched (n = 12/47; 25.5%) versus chamomile-continuation (n = 7/46; 15.2%) participants relapsed during follow-up. Mean time to relapse was 11.4 ± 8.4 weeks for chamomile and 6.3 ± 3.9 weeks for placebo. Hazard of relapse was non-significantly lower for chamomile (hazard ratio, 0.52; 95% CI, 0.20–1.33; P = 0.16). During follow-up, chamomile participants maintained significantly lower GAD symptoms than placebo (P = 0.0032), with significant reductions in body weight (P = 0.046) and mean arterial blood pressure (P = 0.0063). Both treatments had similar low adverse event rates. Conclusions Long-term chamomile was safe and significantly reduced moderate-to-severe GAD symptoms, but did not significantly reduce rate of relapse. Our limited sample size and lower than expected rate of placebo group relapse likely contributed to the non-significant primary outcome finding. Possible chamomile superiority over placebo requires further examination in large-scale studies.

Completed wk 8 1 Noncompliance 23 Completed wk 12 1 Unstable medical condition 27 Randomized to real acupuncture 24 Randomized to sham acupuncture 23 Completed wk 8 23 Completed wk 12 21 Completed wk 12 24 Randomized to usual care 24 Completed wk 4 144 Excluded 33 Declined 111 Ineligible 9 Not interested 24 Time or travel concern 54 Acupuncture in the past 5 y 12 No chemotherapy 15 No CIPN pain 12 No cancer 18 In active treatment The number of participants who completed treatment at weeks 8 and 12 were included in the analysis for those weeks. CIPN indicates chemotherapy-induced peripheral neuropathy.

Background Complementary and Alternative Medicine (CAM) incorporates treatments used by cancer survivors in the attempt to improve quality of life. While population studies have identified factors associated with use, assessment of why patients use CAM or the barriers against utilization have not been examined. Patients and Methods We conducted a cross-sectional survey study in the thoracic, breast, and gastrointestinal medical oncology clinics at an academic cancer center. Clinical and demographic variables were collected by self-report and chart abstraction. Attitudes and beliefs were measured using the validated Attitudes and Beliefs about CAM (ABCAM) instrument. This instrument divides attitudes and beliefs into three domains: expected benefits, perceived barriers, and subjective norms. Results Among 969 participants (response rate 82.7%) surveyed between June 2010 and September 2011, patient age≤65, female gender and college education were associated with significantly greater expected benefit from CAM (p < 0.0001 for all). Non-white patients reported more perceived barriers to CAM use than white patients (p<0.0001), but had a similar degree of expected benefit (p=0.76). In a multivariate logistic regression analysis, all domains of the ABCAM instrument were significantly associated with CAM use (p<0.01 for all) among patients with cancer. Attitudes and beliefs about CAM explained much more variance in CAM use than clinical and demographic variables alone. Conclusion(s) Attitudes and beliefs varied by key clinical and demographic characteristics, and predicted CAM utilization. By developing CAM programs based upon attitudes and beliefs, we may be able to remove barriers among underserved patient populations and provide more patient centered care.

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Background We performed a proof of concept trial to evaluate relative safety and efficacy of Rhodiola rosea (R. rosea) versus sertraline for mild to moderate major depressive disorder. Hypothesis We hypothesize that R. rosea would have similar therapeutic effects as sertraline but with less adverse events. Study Design Phase II randomized placebo controlled clinical trial Methods 57 subjects were randomized to 12 weeks of standardized R. rosea extract, sertraline, or placebo. Changes over time in Hamilton Depression Rating (HAM-D), Beck Depression Inventory (BDI), and Clinical Global Impression Change (CGI/C) scores among groups were examined using mixed-effects models. Results Modest, albeit statistically non-significant, reductions were observed for HAM-D, BDI, and CGI/C scores for all treatment conditions with no significant difference between groups (p=0.79, p=0.28, and p=0.17, respectively). The decline in HAM-D scores was greater for sertraline (−8.2, 95% confidence interval [CI], −12.7 to −3.6) versus R. rosea (−5.1, 95% CI: −8.8 to −1.3) and placebo (−4.6, 95% CI: −8.6 to −0.6). While the odds of improving (versus placebo) were greater for sertraline (1.90 [0.44–8.20]; odds ratio [95% CI]) than R. rosea (1.39 [0.38–5.04]), more subjects on sertraline reported adverse events (63.2%) than R. rosea (30.0%) or placebo (16.7%) (p=0.012). Conclusions Although R. rosea produced less antidepressant effect versus sertraline, it also resulted in significantly fewer adverse events and was better tolerated. These findings suggest that R. rosea, although less effective than sertraline, may possess a more favorable risk to benefit ratio for individuals with mild to moderate depression.