Who Benefits From a Prostate Rectal Spacer? Secondary Analysis of a Phase III Trial.

Purpose: Previously a phase III trial of a hydrogel rectal spacer during prostate radiation therapy found decreased toxicity and a clinically significant improvement in bowel quality of life (QOL) at 3 years by the Expanded Prostate Cancer Index. We performed a secondary analysis to identify men less likely to benefit.

Methods And Materials: Clinical and dosimetric data for the 222 patients enrolled on the SpaceOAR phase III trial were analyzed.

Sexual quality of life following prostate intensity modulated radiation therapy (IMRT) with a rectal/prostate spacer: Secondary analysis of a phase 3 trial.

Background: We previously reported the results of a phase 3 trial evaluating a prostate/rectal hydrogel spacer during prostate intensity modulated radiation therapy, which resulted in decreased rectal dose and toxicity and less decline in bowel quality of life (QOL). A secondary analysis was performed to correlate penile bulb dose and sexual QOL.

Methods And Materials: Sexual QOL was measured with the Expanded Prostate Cancer Index Composite (EPIC) by mean scores, the proportion of patients with a minimal clinically important difference (MID), and analyses of the different items composing the sexual domain.

Continued Benefit to Rectal Separation for Prostate Radiation Therapy: Final Results of a Phase III Trial.

Purpose: SpaceOAR, a Food and Drug Administration-approved hydrogel intended to create a rectal-prostate space, was evaluated in a single-blind phase III trial of image guided intensity modulated radiation therapy. A total of 222 men were randomized 2:1 to the spacer or control group and received 79.2 Gy in 1.

Hydrogel Spacer Prospective Multicenter Randomized Controlled Pivotal Trial: Dosimetric and Clinical Effects of Perirectal Spacer Application in Men Undergoing Prostate Image Guided Intensity Modulated Radiation Therapy.

Purpose: Perirectal spacing, whereby biomaterials are placed between the prostate and rectum, shows promise in reducing rectal dose during prostate cancer radiation therapy. A prospective multicenter randomized controlled pivotal trial was performed to assess outcomes following absorbable spacer (SpaceOAR system) implantation.

Methods And Materials: Overall, 222 patients with clinical stage T1 or T2 prostate cancer underwent computed tomography (CT) and magnetic resonance imaging (MRI) scans for treatment planning, followed with fiducial marker placement, and were randomized to receive spacer injection or no injection (control).

Racial Differences in Blood Lipids Lead to Underestimation of Cardiovascular Risk in Black Women in a Nested observational Study.

Background: During screening for enrollment in a clinical trial, we noticed potential racial disparities in metabolic syndrome variables in women who responded to our study advertisement. We designed a nested observational study to investigate whether metabolic syndrome variables differed between non-Hispanic blacks and non-Hispanic whites.

Methods: The cohort comprised of women who have met the preliminary clinical trial criteria (body mass index [BMI] 25-45, age 20-75 years, and no use of lipid-lowering medications or supplements).

Phase II study of long-term androgen suppression with bevacizumab and intensity-modulated radiation therapy (IMRT) in high-risk prostate cancer.

Purpose: We report a Phase II trial assessing the acute and late toxicities of intensity-modulated radiation therapy (IMRT), long-term androgen suppression (LTAS), and bevacizumab in patients with high-risk localized prostate cancer.

Methods And Materials: We treated 18 patients with LTAS with bicalutamide and goserelin in combination with bevacizumab and IMRT. Bevacizumab (10 mg/kg every 2 weeks) was administered for the first 16 weeks, and 15 mg/kg was then given every 3 weeks for 12 additional weeks, with an IMRT dose of 77.

A program consisting of a phytonutrient-rich medical food and an elimination diet ameliorated fibromyalgia symptoms and promoted toxic-element detoxification in a pilot trial.

Background: An effective treatment for fibromyalgia (FM) has yet to become available.

Objective: To assess the efficacy ofa lifestyle program consisting of a modified elimination diet and a supplemental medical food on clinical symptoms of FM assessed by the Fibromyalgia Impact Questionnaire (FIQ), FibroQuest Symptoms Survey (FibroQuest), Medical Symptoms Questionnaire (MSQ), metallothionein mRNA expression, and urinary toxic element excretion.

Methods: Eight women (aged 48-74 years) were enrolled in an 8-week pilot trial employing a sequential design.

Nutritional supplementation of hop rho iso-alpha acids, berberine, vitamin D₃, and vitamin K₁ produces a favorable bone biomarker profile supporting healthy bone metabolism in postmenopausal women with metabolic syndrome.

Metabolic syndrome poses additional risk for postmenopausal women who are already at risk for osteoporosis. We hypothesized that a nutritional supplement containing anti-inflammatory phytochemicals and essential bone nutrients would produce a favorable bone biomarker profile in postmenopausal women with metabolic syndrome. In this 14-week, randomized trial, 51 women were instructed to consume a modified Mediterranean-style, low-glycemic-load diet and to engage in aerobic exercise.

Subjects with elevated LDL cholesterol and metabolic syndrome benefit from supplementation with soy protein, phytosterols, hops rho iso-alpha acids, and Acacia nilotica proanthocyanidins.

Background: Metabolic syndrome is associated with increased cardiovascular disease (CVD) risk, a risk that is significantly increased when accompanied by elevated low-density lipoprotein cholesterol (LDL-C). Whereas lifestyle therapies are the initial intervention of choice for both of these risk factors, it has not been clearly determined that this approach is efficacious when they occur concomitantly.

Objective: To evaluate effects of supplementing a lifestyle program with a medical food and nutraceutical in individuals with metabolic syndrome and elevated LDL-C.

Hop rho iso-alpha acids, berberine, vitamin D3 and vitamin K1 favorably impact biomarkers of bone turnover in postmenopausal women in a 14-week trial.

Osteoporosis is a major health issue facing postmenopausal women. Increased production of pro-inflammatory cytokines resulting from declining estrogen leads to increased bone resorption. Nutrition can have a positive impact on osteoporosis prevention and amelioration.

A Javascript library that uses Windows Script Host (WSH) to analyze prostate motion data fragmented across a multitude of Excel files by the Calypso 4D Localization System.

The Calypso 4D Localization System records prostate motion continuously during radiation treatment. It stores the data across thousands of Excel files. We developed Javascript (JScript) libraries for Windows Script Host (WSH) that use ActiveX Data Objects, OLE Automation and SQL to statistically analyze the data and display the results as a comprehensible Excel table.

Low circulating adiponectin and resistin, but not leptin, levels are associated with multiple myeloma risk: a case-control study.

Accumulating evidence supports a role for obesity in the etiology of multiple myeloma (MM). The distinct possibility exists that obesity may be linked to MM through altered adipokine secretion and circulating levels, one of which, adiponectin, has a protective role in several malignancies, including leukemia. In this case-control study, we investigated the role of serum adiponectin, resistin, and leptin levels in the etiopathogenesis of MM and we explored their association with several established prognostic factors.

Adiponectin and resistin are associated with risk for myelodysplastic syndrome, independently from the insulin-like growth factor-I (IGF-I) system.

Aim: Obesity has been implicated in the aetiology of myelogenous leukaemia and myelodysplasia (MDS). We hypothesised that altered secretion of adiponectin and resistin may underlie this association. We thus investigated the role of both total and high molecular weight (HMW) adiponectin and resistin in MDS.

Variants of the adiponectin and adiponectin receptor 1 genes and breast cancer risk.

Breast cancer risk is higher among obese women and women with diabetes. Adiponectin is a protein exclusively secreted by adipose tissue, circulating levels of which have been associated with breast cancer risk. Whether genetic variants within the adiponectin pathway are associated with breast cancer risk is unknown.

Circulating adiponectin levels and expression of adiponectin receptors in relation to lung cancer: two case-control studies.

Background: Decreased circulating levels of adiponectin, an adipocyte-secreted hormone and endogenous insulin sensitizer, have been associated with several obesity-related malignancies. Thiazolidinedione administration, which increases adiponectin levels, decreases risk for lung cancer. Whether circulating adiponectin levels are associated with lung cancer and/or whether adiponectin receptors are expressed in lung cancer remains unknown.

Circulating adiponectin and leptin in relation to myelodysplastic syndrome: a case-control study.

Objective: Adiponectin plays a protective role in several malignancies, including myeloblastic leukemia, whereas leptin may increase the proliferation of progenitor cells and may stimulate leukemic cell growth in vitro. We investigated the role of adiponectin and leptin levels in the etiopathogenesis of myelodysplastic syndromes (MDS), a preleukemic condition with increasing incidence which has recently been associated with obesity.

Methods: In a case-control study, 101 cases with incident, histologically confirmed primary MDS and 101 controls matched on gender and age were studied between 2004 and 2007, and blood samples were collected.

Adiponectin receptor expression is elevated in colorectal carcinomas but not in gastrointestinal stromal tumors.

Circulating adiponectin is inversely associated with colorectal carcinoma. However, adiponectin receptor expression has not been examined in normal gastrointestinal tissue, colorectal malignancies, or gastrointestinal stromal tumors (GISTs). We collected 40 colorectal carcinomas and 12 non-tumor colorectal tissue specimens from patients with colorectal cancer, as well as 45 tumor and 13 non-tumor specimens from patients with GIST.

Gene expression of adiponectin receptors in human visceral and subcutaneous adipose tissue is related to insulin resistance and metabolic parameters and is altered in response to physical training.

Objective: Adiponectin receptors 1 and 2 (AdipoR1 and AdipoR2, respectively) mediate the effects of adiponectin on glucose and lipid metabolism in vivo. We examined whether AdipoR1 and/or AdipoR2 mRNA expression in human adipose tissue is fat-depot specific. We also studied whether their expression in visceral and subcutaneous fat depots is associated with metabolic parameters and whether their expression is regulated by intensive physical exercise.

Esophagectomy--it's not just about mortality anymore: standardized perioperative clinical pathways improve outcomes in patients with esophageal cancer.

Background: Esophageal resection (ER) remains the standard therapy for early esophageal cancer; however, because of concerns regarding high levels of morbidity and mortality reported in analyses of national databases, many patients are relegated to less effective endoscopic or chemotherapeutic approaches.

Methods: All patients undergoing esophagectomy by a single surgeon for cancer or high-grade dysplasia between 05/91-05/06 were prospectively entered into an IRB-approved database. All aspects of work-up and treatment were guided by an evolving standardized perioperative clinical pathway.

A Phase II safety and effect on time to tumor progression study of intratumoral light infusion technology using talaporfin sodium in patients with metastatic colorectal cancer.

Background And Objectives: Twenty-seven patients with refractory liver metastases from colorectal cancer took part in a Phase II study of the light infusion technology (Litx) light-activated drug/device system to assess safety and evaluate time to tumor progression (TTP).

Methods: Litx consists of the light-activated drug, talaporfin sodium (LS11), activated intratumorally by a catheter-like array of light-emitting diodes (LEDs). After placement of the array via ultrasound or computed tomography (CT) guidance, LS11 was administered intravenously, followed 15-60 min later by light infusion for 2.

Stereotactic hypofractionated accurate radiotherapy of the prostate (SHARP), 33.5 Gy in five fractions for localized disease: first clinical trial results.

Purpose: To evaluate the feasibility and toxicity of stereotactic hypofractionated accurate radiotherapy (SHARP) for localized prostate cancer.

Methods And Materials: A Phase I/II trial of SHARP performed for localized prostate cancer using 33.5 Gy in 5 fractions, calculated to be biologically equivalent to 78 Gy in 2 Gy fractions (alpha/beta ratio of 1.

Sugarcane ShSUT1: analysis of sucrose transport activity and inhibition by sucralose.

Plant sucrose transporters (SUTs) are members of the glycoside-pentoside-hexuronide (GPH) cation symporter family (TC2.A.2) that is part of the major facilitator superfamily (MFS).

Hyperbaric oxygen therapy for radiation induced proctopathy in men treated for prostate cancer.

Purpose: Radiation proctitis is a common complication following external beam radiation therapy and brachytherapy for prostate cancer. While 95% percent of radiation induced proctitis is temporary and self-limiting, up to 5% of patients experience toxicities that are refractory to conservative management. Hyperbaric oxygen has a well-defined role in treating chronic wounds, osteomyelitis, hemorrhagic cystitis and necrotizing fasciitis.

Intrafractional stability of the prostate using a stereotactic radiotherapy technique.

Purpose: To evaluate the stability of the prostate during stereotactic radiation therapy.

Materials And Methods: Forty-seven patients underwent placement of three fiducial markers into the prostate as part of a pilot study of hypofractionated stereotactic radiotherapy. Portal images before and subsequent to 227 radiotherapy fractions were analyzed for prostate movement.