No abstract

A B S T R A C T PurposeHot flashes occur in approximately 80% of androgen-deprived men. Few intervention studies have been conducted to relieve hot flashes in men. Patients and MethodsEligible androgen-deprived men were randomly assigned to one of four daily regimens (2 ϫ 2 factorial design) for 12 weeks: milk protein powder and placebo pill, venlafaxine and milk protein powder, soy protein powder and placebo pill, or venlafaxine and soy protein powder. The primary end point was hot flash symptom severity score (HFSSS), defined as number of hot flashes times severity. The secondary end point was quality of life (QoL), assessed by using the Functional Assessment of Cancer Therapy-Prostate. ResultsIn all, 120 men age 46 to 91 years participated. Most were white (78%) and overweight or obese (83%). Toxicity was minimal. Neither venlafaxine nor soy protein alone or in combination had a significant effect on HFSSS. Soy protein, but not venlafaxine, improved measures of QoL. ConclusionIn androgen-deprived men, neither venlafaxine nor soy proved effective in reducing hot flashes. Interventions that appear effective for decreasing hot flashes in women may not always turn out to be effective in men.

No abstract

No abstract

In a large-scale catastrophe, such as a nuclear detonation in a major city, it will be crucial to accurately diagnose large numbers of people to direct scarce medical resources to those in greatest need. Currently no FDA-cleared tests are available to diagnose radiation exposures, which can lead to complex, life-threatening injuries. To address this gap, we have achieved substantial advancements in radiation biodosimetry through refinement and adaptation of the cytokinesis-block micronucleus (CBMN) assay as a high throughput, quantitative diagnostic test. The classical CBMN approach, which quantifies micronuclei (MN) resulting from DNA damage, suffers from considerable time and expert labor requirements, in addition to a lack of universal methodology across laboratories. We have developed the CytoRADx™ System to address these drawbacks by implementing a standardized reagent kit, optimized assay protocol, fully automated microscopy and image analysis, and integrated dose prediction. These enhancements allow the CytoRADx System to obtain high-throughput, standardized results without specialized labor or laboratory-specific calibration curves. The CytoRADx System has been optimized for use with both humans and non-human primates (NHP) to quantify radiation dose-dependent formation of micronuclei in lymphocytes, observed using whole blood samples. Cell nuclei and resulting MN are fluorescently stained and preserved on durable microscope slides using materials provided in the kit. Up to 1,000 slides per day are subsequently scanned using the commercially based RADxScan™ Imager with customized software, which automatically quantifies the cellular features and calculates the radiation dose. Using less than 1 mL of blood, irradiated ex vivo, our system has demonstrated accurate and precise measurement of exposures from 0 to 8 Gy (90% of results within 1 Gy of delivered dose). These results were obtained from 636 human samples (24 distinct donors) and 445 NHP samples (30 distinct subjects). The system demonstrated comparable results during in vivo studies, including an investigation of 43 NHPs receiving single-dose total-body irradiation. System performance is repeatable across laboratories, operators, and instruments. Results are also statistically similar across diverse populations, considering various demographics, common medications, medical conditions, and acute injuries associated with radiological disasters. Dose calculations are stable over time as well, providing reproducible results for at least 28 days postirradiation, and for blood specimens collected and stored at room temperature for at least 72 h. The CytoRADx System provides significant advancements in the field of biodosimetry that will enable accurate diagnoses across diverse populations in large-scale emergency scenarios. In addition, our technological enhancements to the well-established CBMN assay provide a pathway for future diagnostic applications, such as toxicology and oncology.

Background: Head and neck cancer (HNC) patients undergoing radiation therapy (RT) experience significant side effects, presenting challenging care tasks for their informal (unpaid) caregivers. HNC caregivers report low caregiving self-efficacy, high distress, and interest in supportive care interventions. Objective: This randomized pilot trial assessed the feasibility and acceptability of a 6 to 7 week supported self-management intervention (Prepare to Care) offering psychoeducation and stress management skills building for caregivers of patients receiving RT for HNC. Methods: Caregivers were randomized to Prepare to Care or standard of care. Primary feasibility measures included participation and retention percentages. Assessments were completed before the intervention, at intervention completion, and 6-weeks later after intervention completion. Results: Caregivers (N = 38) were predominantly female (88.6%), an average age of 56 years old, and a spouse/partner to the patient (71.4%). Participation percent was 42.2%; retention at intervention conclusion was 80% and 77% at the 6-week follow-up. Quantitative and qualitative results support acceptability, with 64% to 88% reporting each intervention module was helpful (quite a bit or very). Intervention caregivers reported a significantly greater improvement in self-efficacy for progressive muscle relaxation (PMR). Conclusions: Prepare to Care and the randomized pilot trial methods are feasible and acceptable for HNC caregivers of patients receiving RT. A significant treatment effect was observed for self-efficacy for PMR, and findings were in the expected direction regarding improved caregiving self-efficacy. Further research is necessary to determine the efficacy of this intervention with a focus on increased engagement strategies and longer-term outcomes. Trial Registration: NCT03032250

No abstract

Background: Salvage external beam radiotherapy (RT) with androgen deprivation therapy (ADT) improves survival over RT in men with prostate cancer (PC) and rising prostate-specific antigen (PSA) levels after radical prostatectomy (RP). Objective: To investigate the safety and efficacy of enzalutamide concurrent with salvage RT and ADT. Design, setting, and participants: This was a three-center prospective phase 2 single-arm trial (NCT02057939) of men with Gleason 7-10 PC and PSA recurrence within 4 yr of RP ranging from 0.2 to 4.0 ng/dl, no prior hormonal therapy, and no radiographic evidence of metastases. We enrolled 38 men; 37 completed therapy and were evaluable with testosterone recovery at 2 yr. Intervention: Six months of ADT with 160 mg/d enzalutamide and 66 Gy RT to the prostate bed. Outcome measurements and statistical analysis: The primary endpoint was improved 2-yr progression-free survival (PFS) over historical controls. Secondary objectives included 3-yr PFS, safety, and patient-reported quality of life (QOL). Results and limitations: The primary endpoint of 2-yr PFS was 65% (95% confidence interval [CI]: 47, 78) versus 51% (95% CI: 33, 67) in a trial of men with similar eligibility treated with salvage RT and adjuvant docetaxel. The 3-yr PFS was 53%.