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Soy protein supplementation in men following radical prostatectomy: a 2-year randomized, placebo-controlled clinical trial.
Bosland, MC, Enk, E, Schmoll, J, Schlicht, MJ, Randolph, C, Deaton, RJ, Xie, H, Zeleniuch-Jacquotte, A, Kato, I
The American journal of clinical nutrition. 2021;(4):821-831
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Abstract
BACKGROUND Many studies have addressed effects of dietary supplementation with soy protein, but most have been inconsistent and few have been long-term studies in men. OBJECTIVES This study was a secondary analysis of body weight, blood pressure, thyroid hormones, iron status, and clinical chemistry in a 2-y trial of soy protein supplementation in middle-aged to older men. METHODS Data were analyzed as secondary outcomes of a randomized controlled trial of dietary supplementation with 20 g/d soy protein isolate, providing 41 mg/d total isoflavones and 23 mg/d genistein, in 44- to 75-y-old men who were at risk of cancer recurrence following prostatectomy randomized to soy (n = 50) or a casein-based placebo (n = 43). Weight, blood pressure, and blood samples were collected at baseline, every 2 mo in year 1, and every 3 mo in year 2. RESULTS Compared with casein, soy supplementation did not affect body weight, blood pressure, serum total cholesterol, calcium, phosphorus, and thyroid hormones. Serum ferritin concentrations doubled over 2 y in both groups (117-129%), whereas hemoglobin and hematocrit increased slightly. In an exploratory subgroup analysis of soy group data, weight increased in subjects producing equol but not in nonproducers. Blood pressure was reduced in nonequol producers but not in producers. Other endpoints were not affected by equol production status. CONCLUSIONS Soy protein supplementation for 2 y compared with a casein-based placebo did not affect body weight, blood pressure, serum total cholesterol, iron status parameters, calcium, phosphorus, and thyroid hormones. Exploratory analysis suggests that equol production status of subjects on soy may modify effects of soy on body weight and possibly blood pressure. This trial was registered at clinicaltrials.gov as NCT00765479.
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A multidisciplinary team-based approach with lifestyle modification and symptom management to address the impact of androgen deprivation therapy in prostate cancer: A randomized phase II study.
Pollock, Y, Zhang, L, Kenfield, SA, Van Blarigan, EL, Rodvelt, T, Rabow, M, Macaire, G, Weinberg, R, Topp, K, Friedlander, T, et al
Urologic oncology. 2021;(10):730.e9-730.e15
Abstract
BACKGROUND Androgen deprivation therapy (ADT) is associated with numerous toxicities that are potentially modifiable. We sought to evaluate the impact of participation in a multidisciplinary clinic, STAND (Supportive Therapy in Androgen Deprivation) Clinic, designed to provide individualized lifestyle modification and management of ADT-related side effects. METHODS This phase II study recruited men with prostate cancer who had started ADT <6 months prior to enrollment, and in whom ADT was planned for at least 12 months following enrollment. Patients were randomized in a 1:1 ratio to either the STAND Clinic or usual care. Patients randomized to the STAND Clinic were provided monthly multidisciplinary assessment and counseling on exercise, nutrition, and symptom management for 12 months on a rotating schedule. Primary outcome was change from baseline to 12 months in percent body fat. Feasibility outcomes were also assessed by measuring percentage of completed visits. Secondary outcomes included change from baseline to 12 months in 3 domains: (1) metabolic impact and bone health, (2) quality of life (QOL), and (3) physical activity. RESULTS A total of 25 men were randomized to STAND clinic, and 23 were randomized to usual care. The study did not meet its accrual target of 32 men in each arm and was closed early due to lack of financial support. Overall, 91% (295 of 325) of STAND clinic visits were completed. Eighteen out of the 25 patients in STAND clinic arm (72%) completed all 12 months of STAND clinic visits, and 80% (20 of 25) completed the first 6 months. For all primary and secondary outcomes, there were no statistically significant differences between treatment arms. CONCLUSION Individualized and comprehensive management of ADT toxicities in a multidisciplinary clinic was well attended by patients. However, we did not find any differences in the outcomes assessed between the intervention arm and control.
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Timing of exercise for muscle strength and physical function in men initiating ADT for prostate cancer.
Newton, RU, Galvão, DA, Spry, N, Joseph, D, Chambers, SK, Gardiner, RA, Hayne, D, Taaffe, DR
Prostate cancer and prostatic diseases. 2020;(3):457-464
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Abstract
BACKGROUND Androgen deprivation therapy (ADT) in men with prostate cancer (PCa) results in adverse effects, including reduced muscle strength and physical function, potentially compromising daily functioning. We examined whether it was more efficacious to commence exercise at the onset of ADT rather than later in treatment to counter declines in strength and physical function. METHODS One-hundred-and-four men with PCa (68.3 ± 7.0 years) initiating ADT were randomised to immediate exercise (IMX, n = 54) or delayed exercise (DEL, n = 50) for 12 months. IMX comprised 6 months of supervised resistance/aerobic/impact exercise initiated at the onset of ADT with a 6-month follow-up. DEL comprised 6 months of usual care followed by 6 months of resistance/aerobic/impact exercise. Upper and lower body muscle strength and physical function were assessed at baseline, 6 and 12 months. RESULTS There was a significant difference for all strength measures at 6 months favouring IMX (P < 0.001), with net differences in leg press, seated row and chest press strength of 19.9 kg (95% CI, 12.3-27.5 kg), 5.6 kg (3.8-7.4 kg) and 4.3 kg (2.7-5.8 kg), respectively. From 7 to 12 months, DEL increased in all strength measures (P < 0.001), with no differences between groups at 12 months. Similarly, physical function improved (P < 0.001) in IMX compared with DEL at 6 months for the 6-m fast walk (-0.2, 95% CI -0.3 to -0.1 s), 400-m walk (-9.7, -14.8 to -4.6 s), stair climb (-0.4, -0.6 to -0.2 s) and chair rise (-1.0, -1.4 to -0.7 s), with no differences between groups by 12 months, except for the 6-m fast walk (P < 0.001). CONCLUSION Exercise either at the onset or after 6 months of ADT preserves/enhances muscle strength and physical function. However, to avoid initial treatment-related adverse effects on strength and function, exercise therapy should be implemented with initiation of ADT.
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Efficacy of Synbiotics to Reduce Symptoms and Rectal Inflammatory Response in Acute Radiation Proctitis: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial.
Nascimento, M, Caporossi, C, Eduardo Aguilar-Nascimento, J, Michelon Castro-Barcellos, H, Teixeira Motta, R, Reis Lima, S
Nutrition and cancer. 2020;(4):602-609
Abstract
Purpose: Evaluate whether the daily intake of synbiotics improves symptoms and rectal/systemic inflammatory response in patients with radiation-induced acute proctitis.Methods and Materials: Twenty patients who underwent three-dimensional conformal radiotherapy for prostate cancer were randomized to intake either a synbiotic powder containing Lactobacillus reuteri (108 CFU) and soluble fiber (4.3 g) or placebo. EORTC QLQ-PRT23 questionnaire was applied before the beginning of radiotherapy and after the fifth, sixth, and seventh weeks of treatment, and the sum of both the complete (proctitis symptoms plus quality of life) and partial (proctitis symptoms) scores were compared. Fecal calprotectin was measured at Day 0 and in the fourth week of treatment, and serum C-reactive protein/albumin ratio were measured in the fourth week of treatment.Results: Both the complete and partial questionnaire score (median and range) were higher in the fifth and sixth weeks in the placebo group; there was a higher increase in fecal calprotectin in the placebo group and no difference comparing CRP/albumin ratio.Conclusions: Synbiotics reduce proctitis symptoms and improve quality of life by preventing rectal inflammation during radiotherapy for prostate cancer.
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Engagement in an Interactive App for Symptom Self-Management during Treatment in Patients With Breast or Prostate Cancer: Mixed Methods Study.
Crafoord, MT, Fjell, M, Sundberg, K, Nilsson, M, Langius-Eklöf, A
Journal of medical Internet research. 2020;(8):e17058
Abstract
BACKGROUND Using mobile technology for symptom management and self-care can improve patient-clinician communication and clinical outcomes in patients with cancer. The interactive app Interaktor has been shown to reduce symptom burden during cancer treatment. It includes symptom assessment, an alert system for contact with health care professionals, access to self-care advice, and visualization of symptom history. It is essential to understand how digital interventions operate; one approach is to examine engagement by assessing usage and exploring user experiences. Actual usage in relation to the intended use-adherence-is an essential factor of engagement. OBJECTIVE This study aimed to describe engagement with the Interaktor app among patients with breast or prostate cancer during treatment. METHODS Patients from the intervention groups of two separate randomized controlled trials were included: patients with breast cancer receiving neoadjuvant chemotherapy (n=74) and patients with locally advanced prostate cancer receiving treatment with radiotherapy (n=75). The patients reported their symptoms daily. Sociodemographic and clinical data were obtained from baseline questionnaires and medical records. Logged data usage was retrieved from the server and analyzed descriptively and with multiple regression analysis. Telephone interviews were conducted with patients about their perceptions of using the app and analyzed using content analysis. RESULTS The median adherence percentage to daily symptom reporting was 83%. Most patients used the self-care advice and free text message component. Among the patients treated for breast cancer, higher age predicted a higher total number of free text messages sent (P=.04). Among the patients treated for prostate cancer, higher age (P=.01) and higher education level (P=.04), predicted an increase in total views on self-care advice, while higher comorbidity (P=.004) predicted a decrease in total views on self-care advice. Being married or living with a partner predicted a higher adherence to daily symptom reporting (P=.02). Daily symptom reporting created feelings of having continuous contact with health care professionals, being acknowledged, and safe. Being contacted by a nurse after a symptom alert was considered convenient and highly valued. Treatment and time-related aspects influenced engagement. Daily symptom reporting was perceived as particularly meaningful at the beginning of treatment. Requests were made for advice on diet and psychological symptoms, as well as for more comprehensive and detailed information as the patient progressed through treatment. CONCLUSIONS Patient engagement in the interactive app Interaktor was high. The app promoted patient participation in their care through continuous and convenient contact with health care professionals. The predictive ability of demographic variables differed between patient groups, but higher age and a higher educational level predicted higher usage of specific app functions for both patient groups. Patients' experience of relevance and interactivity influenced their engagement positively.
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Compliance with the 2018 World Cancer Research Fund/American Institute for Cancer Research Cancer Prevention Recommendations and Prostate Cancer.
Olmedo-Requena, R, Lozano-Lorca, M, Salcedo-Bellido, I, Jiménez-Pacheco, A, Vázquez-Alonso, F, García-Caballos, M, Sánchez, MJ, Jiménez-Moleón, JJ
Nutrients. 2020;(3)
Abstract
The etiology of prostate cancer (PCa) remains largely unknown. Compliance with the 2018 World Cancer Research Fund/American Institute for Cancer Research (WCRC/AICR) cancer prevention recommendations and its relationship to PCa was evaluated. A total of 398 incident PCa cases and 302 controls were included. The selection criteria for both cases and controls were: (i) age between 40-80 years; and (ii) residence in the coverage area of the reference hospitals for 6 months or more prior to recruitment. A score to measure the compliance with the recommendations of 2018 WCRC/AICR criteria was built. The level of compliance was used as a continuous variable and categorized in terciles. The aggressiveness of PCa was determined according to the ISUP classification. Adjusted odds ratios (aOR) and their 95% confidence intervals (95% CI) were estimated using multivariable logistic regression models. A slight protective tendency was observed between the level of compliance with the preventive recommendations and PCa risk, aOR = 0.81 (95% CI 0.69-0.96) for the total cases of PCa. This association also was observed when the aggressiveness was considered. In addition, limiting consumption of "fast foods", sugar-sweetened drinks, and alcohol were independently associated with lower risk of PCa.
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Does trunk muscle training with an oscillating rod improve urinary incontinence after radical prostatectomy? A prospective randomized controlled trial.
Heydenreich, M, Puta, C, Gabriel, HH, Dietze, A, Wright, P, Zermann, DH
Clinical rehabilitation. 2020;(3):320-333
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OBJECTIVE To investigate the effect of a new therapeutic approach, using an oscillating rod to strength the pelvic floor and deep abdominal musculature and to speed up recovery of continence after radical prostatectomy. DESIGN Prospective randomized controlled clinical trial. SETTING Inpatient uro-oncology rehabilitation clinic. SUBJECTS Ninety-three (intervention group (IG)) and ninety-one patients (control group (CG)) with urinary incontinence after prostatectomy were examined. INTERVENTION All patients were randomly allocated to either standard pelvic floor muscle exercises and oscillating rod therapy (IG) or standard pelvic floor muscle exercises and relaxation therapy (CG). MAIN OUTCOME MEASURES Urinary incontinence (1- and 24-hour pad test) was assessed, and health-related quality of life (HRQL; Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire) was measured for all patients before and after three weeks of treatment. RESULTS One hundred and eighty-four patients (mean (SD) age: 64.1 (6.94) years) completed the study. The IG showed a significant reduction in urinary incontinence (1-hour pad test: P = 0.008, 24-hour pad test: P = 0.012) and a significant improvement of HRQL (P = 0.017) compared with CG. Continence was significantly improved in both groups (1-hour pad test: 22.6-8.5 g (IG) vs. 23.0-18.1 g (CG)/24-hour pad test: 242.9-126.7 g (IG) vs. 237.6-180.9 g (CG)). CONCLUSION The study demonstrated that a combination of conventional continence exercises and the new oscillation rod training increased abdominal and pelvic floor musculature and speeded up recovery of continence after radical prostatectomy.
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Experiences of a nutrition intervention-A qualitative study within a randomised controlled trial in men undergoing radiotherapy for prostate cancer.
Forslund, M, Nygren, P, Ottenblad, A, Johansson, B
Nutrition & dietetics: the journal of the Dietitians Association of Australia. 2020;(2):223-230
Abstract
AIM: Men with prostate cancer undergoing radiotherapy may experience acute and late bowel symptoms. Nutrition interventions have shown some benefits, however, adherence tends to decline over time. Qualitative studies, carried out after an intervention, are important to help explain trial results. The aim of the present study was to explore patient experience of participating in a nutrition intervention in a randomised controlled trial, with a focus on facilitators and barriers to adherence. METHODS Semistructured interviews were conducted with 15 men with prostate cancer recruited from a randomised controlled trial on a nutrition intervention during radiotherapy. Interviews were analysed with content analysis with an inductive approach. RESULTS The informants were motivated to make dietary changes to avoid bowel symptoms. Social support, a feeling of contributing to the greater good, prior knowledge, dietary information and a small need for behaviour change facilitated adherence. Feeling limited, wanting to decide for themselves, the timing of the intervention, unmet expectations of dietary advice and loss of motivation, were described as barriers for adherence. CONCLUSIONS Future nutrition intervention trials may benefit from involving significant others to a greater degree, as well as offering pre-set recipes and strategies to manage social events, and more sessions with the dietitian for patients in need of more support. Tailored interventions based on the individual's preferences, context and prior knowledge about food may further facilitate adherence.
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Responsiveness to Resistance-Based Multimodal Exercise Among Men With Prostate Cancer Receiving Androgen Deprivation Therapy.
Taaffe, DR, Newton, RU, Spry, N, Joseph, DJ, Galvão, DA
Journal of the National Comprehensive Cancer Network : JNCCN. 2019;(10):1211-1220
Abstract
BACKGROUND Androgen deprivation therapy (ADT) in the management of prostate cancer (PCa) results in an array of adverse effects, and exercise is one strategy to counter treatment-related musculoskeletal toxicities. This study assessed the prevalence of exercise responsiveness in men with PCa undergoing ADT in terms of body composition, muscle strength, and physical function. METHODS Prospective analyses were performed in 152 men (aged 43-90 years) with PCa receiving ADT who were engaged in resistance exercise combined with aerobic or impact training for 3 to 6 months. Whole-body lean mass and fat mass (FM), trunk FM, and appendicular skeletal muscle were assessed with dual x-ray absorptiometry; upper and lower body muscle strength were assessed with the one-repetition maximum; and physical function was assessed with a battery of tests (6-m usual, fast, and backward walk; 400-m walk; repeated chair rise; stair climb). RESULTS Significant improvements were seen (P<.01) in lean mass (0.4±1.4 kg [range, -2.8 to +4.1 kg]), appendicular skeletal muscle (0.2±0.8 kg [range, -1.9 to +1.9 kg]), and all measures of muscle strength (chest press, 2.9±5.8 kg [range, -12.5 to +37.5 kg]; leg press, 29.2±27.6 kg [range, -50.0 to +140.0 kg]) and physical function (from -0.1±0.5 s [range, +1.3 to -2.1 s] for the 6-m walk; to -8.6±15.2 s [range, +25.2 to -69.7 s] for the 400-m walk). An increase in FM was also noted (0.6±1.8 kg [range, -3.6 to +7.3 kg]; P<.01). A total of 21 men did not exhibit a favorable response in at least one body composition component, 10 did not experience improved muscle strength, and 2 did not have improved physical function. However, all patients responded in at least one of the areas, and 120 (79%) favorably responded in all 3 areas. CONCLUSIONS Despite considerable heterogeneity, most men with PCa receiving ADT responded to resistance-based multimodal exercise, and therefore our findings indicate that this form of exercise can be confidently prescribed to produce beneficial effects during active treatment.
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A lifestyle intervention of weight loss via a low-carbohydrate diet plus walking to reduce metabolic disturbances caused by androgen deprivation therapy among prostate cancer patients: carbohydrate and prostate study 1 (CAPS1) randomized controlled trial.
Freedland, SJ, Howard, L, Allen, J, Smith, J, Stout, J, Aronson, W, Inman, BA, Armstrong, AJ, George, D, Westman, E, et al
Prostate cancer and prostatic diseases. 2019;(3):428-437
Abstract
PURPOSE The objective of this study was to test a low-carbohydrate diet (LCD) plus walking to reduce androgen deprivation therapy (ADT)-induced metabolic disturbances. MATERIALS AND METHODS This randomized multi-center trial of prostate cancer (PCa) patients initiating ADT was designed to compare an LCD (≤20g carbohydrate/day) plus walking (≥30 min for ≥5 days/week) intervention vs. control advised to maintain usual diet and exercise patterns. Primary outcome was change in insulin resistance by homeostatic model assessment at 6 months. To detect 20% reduction in insulin resistance, 100 men were required. The study was stopped early after randomizing 42 men due to slow accrual. Secondary outcomes included weight, body composition, lipids, and prostate-specific antigen (PSA). Changes from baseline were compared between arms using rank-sum tests. RESULTS At 6 months, LCD/walking reduced insulin resistance by 4% vs. 36% increase in control (p = 0.13). At 3 months, vs. control, LCD/walking arm significantly lost weight (7.8kg; p<0.001), improved insulin resistance (↑36%; p = 0.015), hemoglobin A1c (↓3.3%; p = 0.01), high-density lipoprotein (HDL) (↑13%; p = 0.004), and triglyceride (↓37%; p = 0.036). At 6 months, weight loss (10.6kg; p<0.001) and HDL (↑27%; p = 0.003) remained significant. LCD/walking preserved total body bone mineral count (p = 0.025), reduced fat mass (p = 0.002), lean mass (p = 0.036), and percent body fat (p = 0.004). There were no differences in PSA. Limitations include the effect of LCD, weight loss vs. walking instruction are indistinguishable, and small sample size. CONCLUSIONS In an underpowered study, LCD/walking did not improve insulin sensitivity at 6 months. Given most secondary outcomes were improved at 3 months with some remaining improved at 6 months and a secondary analysis showed that LCD/walking reduced insulin resistance over the study, supporting future larger studies of LCD/walking intervention to reduce ADT-induced disturbances.