A whole food, plant-based randomized controlled trial in metastatic breast cancer: feasibility, nutrient, and patient-reported outcomes.

PURPOSE: Quality of life (QOL) is among the most important outcomes for women with metastatic breast cancer (MBC), and it predicts survival. QOL is negatively impacted by cognitive impairment, fatigue, and weight gain. We assessed whether a whole food, plant-based (WFPB) diet-promoting weight loss is feasible and might improve QOL. METHODS: Women with MBC on stable systemic treatments were randomized 2:1 to 1) WFPB dietary intervention (n = 21) or 2) usual care (n = 11) for 8 weeks. Participants attended weekly education visits and consumed an ad libitum WFPB diet (3 prepared meals/day provided). Patient-reported outcomes and 3-day food records were assessed at baseline and 8 weeks. The effects of WFPB diet on changes in outcomes were assessed by analysis of covariance model controlling for baseline. RESULTS: 20 intervention and 10 control participants completed the trial. Intervention participants were highly adherent to the WFPB diet (94.3 % total calories on-plan). Intervention group nutrient intakes changed significantly including dietary fat (35.8 % to 20.4 % percent calories from fat, p < 0.001) and fiber content (12.7 to 30.8 g fiber/1000 kcal, p < 0.001). Perceived cognitive function (FACT-Cog total + 16.1; 95 % confidence interval [CI] = 0.8-31.7; p = 0.040) and emotional well-being (FACT-B emotional well-being subscale + 2.3; CI = 0.5-4.1; p = 0.016) improved in the WFPB versus the control group. Fatigue, measured by the BFI, improved within the WFPB group for fatigue severity (M = 4.7 ± 2.5[SD] to 3.7 ± 2.3, p = 0.047) and fatigue at its worst (5.8 ± 2.8 to 4.4 ± 2.4, p = 0.011). CONCLUSIONS: Significant dietary changes in this population are feasible and may improve QOL by improving treatment-related symptoms. Additional study is warranted. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03045289. Registered 7 February 2017.

A whole-food, plant-based randomized controlled trial in metastatic breast cancer: weight, cardiometabolic, and hormonal outcomes.

PURPOSE: Breast cancer treatment is associated with weight gain, and obesity and its related cardiometabolic and hormonal risk factors have been associated with poorer outcomes. Dietary intervention may address these risk factors, but limited research has been done in the setting of metastatic breast cancer requiring systemic therapy. METHODS: Women with metastatic breast cancer on stable treatment were randomized 2:1 to an 8-week intervention (n = 21) or control (n = 11). The intervention included weekly assessment visits and an ad libitum whole-food, plant-based (WFPB) diet with provided meals. Cardiometabolic, hormonal, and cancer markers were assessed at baseline, 4 weeks, and 8 weeks. RESULTS: Within the intervention group, mean weight decreased by 6.6% (p < 0.01) after 8 weeks. Fasting insulin decreased from 16.8 uIU/L to 11.2 uIU/L (p < 0.01), concurrent with significantly reduced insulin resistance. Total cholesterol decreased from 193.6 mg/dL to 159 mg/dL (p < 0.01), and low-density lipoprotein (LDL) cholesterol decreased from 104.6 mg/dL to 82.2 mg/dL (p < 0.01). Total testosterone was unchanged, but free testosterone trended lower within the intervention group (p = 0.08) as sex hormone binding globulin increased from 74.3 nmol/L to 98.2 nmol/L (p < 0.01). There were no significant differences in cancer progression markers at week 8, although mean CA 15-3, CA 27.29, and CEA were lower in the intervention group (p = 0.53, p = 0.23, and p = 0.54, respectively) compared to control, when adjusted for baseline. CONCLUSION: WFPB dietary changes during treatment for metastatic breast cancer are well tolerated and significantly improve weight, cardiometabolic and hormonal parameters. Longer studies are warranted to assess the durability of changes. Trial registration First registered at Clinicaltrials.gov (NCT03045289) on February 7, 2017.

Pregnant Women and Opioid Use Disorder: Examining the Legal Landscape for Controlling Women's Reproductive Health.

Women with opioid use disorder ("OUD") are more likely than other women to experience sexual assault, unintentional pregnancy, transactional sex and coercion regarding reproductive health care choices than women without OUD. Laws described as family friendly may be punitive rather than helpful to women and rarely apply to men. Laws regarding reproductive health and OUD are unevenly enforced and therefore biased against poor, minority women. As part of a larger study oriented toward strengthening systems of care related to the intersection of HIV and OUD, we conducted an analysis of state laws related to pregnant and postpartum women with OUD. Data on disparities in child removals and pregnant women's use of evidence-based treatment for OUD by income and race were captured for the five states with the most restrictive laws in both categories. Laws that were purportedly designed to improve reproductive health outcomes for women with OUD and/or their children often have the opposite of the expressed intended outcome. There is a relationship between restrictive reproductive choice and coercive OUD treatment policy for women. Restrictive state regulations for pregnant women with OUD persist despite negative outcomes for maternal and child health. Altering coercive and/or criminalizing regulation and redefining 'family friendly' may improve outcomes for individuals and families.

Efficacy of Visual Retraining in the Hemianopic Field after Stroke: Results of a Randomized Clinical Trial.

PURPOSE: To evaluate the efficacy of motion discrimination training as a potential therapy for stroke-induced hemianopic visual field defects. DESIGN: Clinical trial. PARTICIPANTS: Forty-eight patients with stroke-induced homonymous hemianopia (HH) were randomized into 2 training arms: intervention and control. Patients were between 21 and 75 years of age and showed no ocular issues at presentation. METHODS: Patients were trained on a motion discrimination task previously evidenced to reduce visual field deficits, but not in a randomized clinical trial. Patients were randomized with equal allocation to receive training in either their sighted or deficit visual fields. Training was performed at home for 6 months, consisting of repeated visual discriminations at a single location for 20 to 30 minutes daily. Study staff and patients were masked to training type. Testing before and after training was identical, consisting of Humphrey visual fields (Carl Zeiss Meditech), macular integrity assessment perimetry, OCT, motion discrimination performance, and visual quality-of-life questionnaires. MAIN OUTCOME MEASURES: Primary outcome measures were changes in perimetric mean deviation (PMD) on Humphrey Visual Field Analyzer in both eyes. RESULTS: Mean PMDs improved over 6 months in deficit-trained patients (mean change in the right eye, 0.58 dB; 95% confidence interval, 0.07-1.08 dB; mean change in the left eye 0.84 dB; 95% confidence interval, 0.22-1.47 dB). No improvement was observed in sighted-trained patients (mean change in the right eye, 0.12 dB; 95% confidence interval, -0.38 to 0.62 dB; mean change in the left eye, 0.10 dB; 95% confidence interval, -0.52 to 0.72 dB). However, no significant differences were found between the alternative training methods (right eye, P = 0.19; left eye, P = 0.10). CONCLUSIONS: To date, no widely accepted therapy is available to treat HH. This study evaluated the efficacy of a promising potential treatment, visual perceptual training. We failed to find a difference between treatment training within the deficit field and control training within the sighted field when performed in a home environment.

Rationale, development, implementation, and initial results of a fast track protocol for transfemoral transcatheter aortic valve replacement (TAVR).

BACKGROUND: The care pathway for patients undergoing transcatheter aortic valve replacement (TAVR), particularly in the US, was initially based on open surgical techniques and often includes general anesthesia, transesophageal echocardiographic monitoring, and cardiothoracic intensive care unit (ICU) stays. Whether a subgroup of patients could benefit from early extubation, fewer days in the ICU, and early ambulation in terms of both cost and effectiveness is unknown. METHODS AND RESULTS: A fast track (FT) protocol was initiated at two institutions in our health system with specific inclusion criteria. Patients with complications or morbidity post procedure deemed ineligible to continue on the FT pathway were designated as deviations. Baseline characteristics, success and deviations, subsequent course, and direct costs were compared for FT eligible and ineligible patients over a 6-month study period. Among 99 patients undergoing Transfemoral TAVR, 39 (39%) met FT inclusion criteria. The mean age of eligible and ineligible patients was similar at 85 years, but by design, eligible patients had fewer co-morbid conditions. Successful completion of the FT protocol was achieved in 28 patients (72%). Patients on the FT had shorter ICU stays (28 ± 103 vs 45 ± 46 hours, P < 0.0001) and post-operative length of stay (4.3 ± 4.4 vs 7.2 ± 5.3 days, P < 0.0001), and incurred lower direct costs ($44,923 ± $14,187 vs $56, 339 ± 17,808, P < 0.0001). CONCLUSIONS: It is feasible to identify a large percentage of suitable patients preprocedure who are eligible for a FT postprocedure care pathway. There was no evidence for compromise of care and successful completion of the pathway was associated with shorter length of stay and fewer direct costs.

Changes in the consumption of isoflavones, omega-6, and omega-3 fatty acids in women with metastatic breast cancer adopting a whole-food, plant-based diet: post-hoc analysis of nutrient intake data from an 8-week randomized controlled trial.

Background: Diets rich in minimally processed plant-based foods are recommended to breast cancer patients, and some may have an interest in whole-food, plant-based (WFPB) diets that avoid animal-based foods, added fats, and refined sugars. Within WFPB diets, the intakes of isoflavones, omega-6 polyunsaturated fatty acids (n-6 PUFAs), and omega-3 polyunsaturated FAs (n-3 PUFAs), which have been discussed in reference to breast cancer outcomes, have not been well characterized. Methods: Women with stage IV breast cancer on stable therapy were randomized 2:1 into (1) a WFPB intervention (N = 21) or (2) usual care (N = 11) for 8 weeks. Three meals per day were provided. Outcomes presented here include dietary intake of isoflavones, n-3 and n-6- PUFAs, which were assessed using three-day food records at baseline and 8 weeks. Baseline and 8-week mean intake within groups were compared using the Wilcoxon signed-rank test and between control and intervention groups by a two-sample t-test. Results: The WFPB intervention participants increased their daily consumption of total isoflavones from a mean of 0.8 mg/day to 14.5 mg/day (p < 0.0001) and decreased the n-6:n-3 ratio of their diet from a mean of 9.3 to 3.7 (p < 0.0001). Within the WFPB group, linoleic acid (n-6 PUFA) consumption decreased by a mean of 3.8 g (p = 0.0095), from 12.8 g/day to 9.0 g/day; total n-3 PUFA consumption increased by a mean of 1.1 g (p = 0.0005), from 1.6 g/day to 2.7 g/day. Conclusion: Transitioning to a WFPB diet resulted in significantly increased isoflavone intake and decreased n-6:n-3 ratio in women with breast cancer.

Post hoc analysis of food costs associated with Dietary Approaches to Stop Hypertension diet, whole food, plant-based diet, and typical baseline diet of individuals with insulin-treated type 2 diabetes mellitus in a nonrandomized crossover trial with meals provided.

BACKGROUND: Americans consume diets that fall short of dietary recommendations, and the cost of healthier diets is often cited as a barrier to dietary change. We conducted a nonrandomized crossover trial with meals provided utilizing 2 diets: Dietary Approaches to Stop Hypertension (DASH) and whole food, plant-based (WFPB), and thus had intake data from baseline and both intervention diets. OBJECTIVES: Using actual diet records, describe food costs of baseline diets of individuals with type 2 diabetes (T2DM) as well as therapeutic DASH and WFPB diets. METHODS: Three-day food records were collected and analyzed for each 7-d diet phase: baseline, DASH, and WFPB. Nutrient content was analyzed using the Nutrient Data System for Research and cost was determined using Fillet, an application to manage menu pricing. Food costs were calculated for each diet as consumed and adjusted to a standardized 1800 kcal/d. Ingredient-only costs of food away from home (FAFH) were approximated and analyzed. Costs were analyzed using linear mixed-effect models as a function of diet. RESULTS: Fifteen subjects enrolled; 12 completed all dietary phases. The baseline, DASH, and WFPB diets, as consumed, cost $15.72/d (95% CI; $13.91, $17.53), $12.74/d ($11.23, $14.25), and $9.78/d ($7.97, $11.59), respectively. When adjusted to an 1800 kcal/d intake, the baseline, DASH, and WFPB diets cost $15.69/d ($13.87, $17.52), $14.92/d ($13.59, $16.26), and $11.96/d ($10.14, $13.78), respectively. When approximated ingredient-only costs of FAFH were analyzed, as consumed baseline [$11.01 ($9.53, $12.49)] and DASH diets [$11.81 ($10.44, $13.18)] had similar costs; WFPB diet [$8.83 ($7.35, $10.31)] cost the least. CONCLUSIONS: In this short-term study with meals provided, the food costs of plant-predominant diets offering substantial metabolic health benefits were less than or similar to baseline food costs of adults with insulin-treated T2DM. Longer-term data without meal provision are needed for more generalizable results. This trial was registered at clinicaltrials.gov as NCT04048642.

Transaortic TAVR and Mitral Repair Under Deep Hypothermic Circulatory Arrest in a Porcelain Aorta Patient.

Vascular and valvular calcifications, commonly seen in renal patients, increase operative mortality and can preclude conventional valvular management. We show a novel approach to treat aortic stenosis and degenerative mitral regurgitation under hypothermic circulatory arrest in a hemodialysis patient with aortic, mitral disease and porcelain aorta with surgical and transcatheter contraindications.

A Whole Food, Plant-Based Randomized Controlled Trial in Metastatic Breast Cancer: Feasibility, Nutrient, and Patient-Reported Outcomes.

Purpose: Quality of life (QOL) is among the most important outcomes for women with metastatic breast cancer (MBC) and it predicts survival. QOL is negatively impacted by cognitive impairment, fatigue, and weight gain. We assessed whether a whole food, plant-based (WFPB) diet promoting weight loss is feasible and might improve QOL. Methods: Women with MBC on stable systemic treatments were randomized 2:1 to 1) WFPB dietary intervention (n = 21) or 2) usual care (n = 11) for 8 weeks. Participants attended weekly education visits and consumed an ad libitum WFPB diet (3 prepared meals/day provided). Patient-reported outcomes and 3-day food records were assessed at baseline and 8 weeks. The effects of WFPB diet on changes in outcomes were assessed by analysis of covariance model controlling for baseline. Results: 20 intervention and 10 control participants completed the trial. Intervention participants were highly adherent to the WFPB diet (94.3% total calories on-plan). Intervention group nutrient intakes changed significantly including dietary fat (35.8-20.4% percent calories from fat, p < 0.001) and fiber content (22.1 to 40.8 grams fiber/1000 kcal, p < 0.001). Perceived cognitive function (FACT-Cog total + 16.1; 95% confidence interval [CI] = 0.8-31.7; p = 0.040) and emotional well-being (FACT-B emotional well-being subscale + 2.3; CI = 0.5-4.1; p = 0.016) improved in the WFPB versus the control group. Fatigue, measured by the BFI, improved within the WFPB group for fatigue severity (M = 4.7 ± 2.5[SD] to 3.7 ± 2.3, p = 0.047) and fatigue at its worst (5.8 ± 2.8 to 4.4 ± 2.4, p = 0.011). Conclusions: Significant dietary changes in this population are feasible and may improve QOL by improving treatment-related symptoms. Additional study is warranted. Trial registration: ClinicalTrials.gov identifier: NCT03045289. Registered 7 February 2017.

A Whole-Food, Plant-Based Randomized Controlled Trial in Metastatic Breast Cancer: Weight, Cardiometabolic, and Hormonal Outcome.

Purpose: Breast cancer treatment is associated with weight gain, and obesity and its related cardiometabolic and hormonal risk factors have been associated with poorer outcomes. Dietary intervention may address these risk factors, but limited research has been done in the setting of metastatic breast cancer requiring systemic therapy. Methods: Women with metastatic breast cancer on stable treatment were randomized 2:1 to an 8-week intervention (n = 21) or control (n = 11). The intervention included weekly assessment visits and an ad libitum whole food, plant-based (WFPB) diet with provided meals. Cardiometabolic, hormonal, and cancer markers were assessed at baseline, 4 weeks, and 8 weeks. Results: Within the intervention group, mean weight decreased by 6.6% (p < 0.01) after 8 weeks. Fasting insulin decreased from 16.8 uIU/L to 11.2 uIU/L (p < 0.01), concurrent with significantly reduced insulin resistance. Total cholesterol decreased from 193.6 mg/dL to 159 mg/dL (p < 0.01) and low-density lipoprotein (LDL) cholesterol decreased from 104.6 mg/dL to 82.2 mg/dL (p < 0.01). Total testosterone was unchanged, but free testosterone trended lower within the intervention group (p = 0.08) as sex hormone binding globulin increased from 74.3 nmol/L to 98.2 nmol/L (p < 0.01). There were no significant differences in cancer progression markers at week 8, although mean CA 15 - 3, CA 27.29, and CEA were lower in the intervention group (p = 0.53, p = 0.23, and p = 0.54, respectively) compared to control, when adjusted for baseline. Conclusion: WFPB dietary changes during treatment for metastatic breast cancer are well tolerated and significantly improve weight and cardiometabolic and hormonal parameters. Longer studies are warranted to assess the durability of changes. Trial registration: First registered at Clinicaltrials.gov (NCT03045289) on February 7, 2017.

The acute effects of a DASH diet and whole food, plant-based diet on insulin requirements and related cardiometabolic markers in individuals with insulin-treated type 2 diabetes.

AIMS: There is limited research regarding insulin dosing changes following adoption of plant-based diets. We conducted a nonrandomized crossover trial utilizing two plant-based diets (Dietary Approaches to Stop Hypertension, or DASH, and Whole Food, Plant-Based, or WFPB) to assess acute changes in insulin requirements and associated markers among individuals with insulin-treated type 2 diabetes. METHODS: Participants (n = 15) enrolled in a 4-week trial with sequential, one-week phases: Baseline, DASH 1, WFPB, and DASH 2. Each diet was ad libitum and meals were provided. RESULTS: Compared to baseline, daily insulin usage was 24%, 39%, and 30% lower after DASH 1, WFPB, and DASH 2 weeks respectively (all p < 0.01). Insulin resistance (HOMA-IR) was 49% lower (p < 0.01) and the insulin sensitivity index was 38% higher (p < 0.01) at the end of the WFPB week before regressing toward baseline during DASH 2. Total, LDL, and HDL cholesterol, leptin, urinary glucose, and hsCRP decreased to a nadir at the end of the WFPB week before increasing during DASH 2. CONCLUSIONS: Adopting a DASH or WFPB diet can result in significant, rapid changes in insulin requirements, insulin sensitivity, and related markers among individuals with insulin-treated type 2 diabetes, with larger dietary changes producing larger benefits.

The Relationship Between Optic Disc Volume, Area, and Frisén Score in Patients With Idiopathic Intracranial Hypertension.

PURPOSE: To compare measurements of papilledema using fundus photography, optical coherence tomography (OCT), and Frisén score in patients with idiopathic intracranial hypertension (IIH). DESIGN: Retrospective, noncomparative analysis of randomized controlled trial data. METHODS: The Idiopathic Intracranial Hypertension Treatment Trial (IIHTT) evaluated weight management and treatment with acetazolamide compared with placebo in patients with IIH and mild visual loss. Among the 126 subjects in the IIHTT OCT substudy, fundus photographs and OCT scans of the optic disc were taken at baseline and at 6 and 12 months after enrollment. Trained readers scored each eye using a modified Frisén scale and measured the area of disc elevation. OCT scans assessed optic nerve head (ONH) volume. Correlations between volume and area were computed for both study and nonstudy eyes. RESULTS: Disc area and ONH volume were positively correlated at baseline (R2 = 0.77 in study eyes, P < .001). Correlations between area and volume were similar in the treatment groups at baseline, but were weaker in the acetazolamide group compared with the placebo group at 6 months (R2 = 0.25 vs R2 = 0.76 in study eyes) and 12 months (R2 = 0.19 vs R2 = 0.65 in study eyes). At 6 and 12 months after enrollment, there was no consistent relationship between Frisén score, disc area, and ONH volumes in the acetazolamide group. CONCLUSION: Frisén score fails to reflect the photographic area and OCT volume of papilledema after treatment with acetazolamide. Clinicians should use caution when using the Frisén scale to monitor the effect of treatment on papilledema over time.

Off-pump coronary revascularization: is it all that it's cracked up to be?

There has been a recent resurgence in the use of off-pump coronary artery surgery. This article provides the critical care nurse with information about the procedure.