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NCT ID: NCT03528876 Not yet recruiting - Clinical trials for Metastatic Gastro-esophageal Adenocarcinoma

FOLFIRI Alternate With FOLFOX in Untreated Metastatic Gastric and Esophageal Adenocarcinoma

LOGIC
Start date: July 1, 2018
Phase: Phase 2
Study type: Interventional

Background: Gastro-esophageal (GE) cancers are a highly aggressive disease and are one of the major causes of cancer-related death worldwide. In general, combination chemotherapy has been associated with better outcomes compared with single agent chemotherapy. Fluoropyrimidine doublets FOLFOX (infusional 5FU and oxaliplatin) or FOLFIRI (infusional 5FU and irinotecan) are some of the standard first-line regimens and are less toxic than the anthracycline containing three drug regimen. Although platinum compounds are very effective in GE cancers, patients who are treated with platinum-based therapy often develop severe neuropathy and may not be able to tolerate a salvage second-line paclitaxel-based therapy. Objectives: To evaluate progression free survival, time to progression, overall survival, toxicity and quality of life in previously untreated patients with metastatic GE cancers who will be treated with a novel biweekly regimen comprised of two cycles of FOLFOX alternating with two cycles of FOLFIRI. To determine the correlation between various clinical and pathological biomarkers including an early FDG-PET scan response and patient outcomes. Design: Phase 2 clinical trial Methods: Thirty-six adult patients with histologically proven HER2 negative metastatic adenocarcinomas or poorly differentiated GE cancers will be recruited at the two major cancer centers in Saskatchewan over a period of two years. Patients will receive chemotherapy every two weeks and will undergo periodic imaging studies every 8 weeks. A Cox proportional analysis will be performed to assess various clinical and pathologic factors including an early FDG-PET/CT response and their correlation with patient outcomes. Significance: The LOGIC study aims to develop an effective but potentially less toxic regimen in the management of metastatic GE cancers, offering the possibility of longer disease control as a result of 100% exposure to two active doublets in a first-line treatment setting with lower neurotoxicities and an improved rate of salvage second-line therapy. This study will inform the care of patients with metastatic GE cancers and will be used to design a larger phase 3 trial to establish a more effective but less toxic chemotherapy regimen for patients with metastatic GE cancer and to establish role of FDG-PET/CT scan and other biomarkers in predicting outcomes.

NCT ID: NCT03528733 Not yet recruiting - Lung Tumor Clinical Trials

Feasibility of Multi-Energy Digital Radiography Detector for Lung Lesion Detection

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

A single-centre, industry sponsored, pilot study to assess the feasibility of Single Exposure Dual Energy Subtraction with a Multi-Energy digital radiography detector as an imaging platform for lung lesion detection.

NCT ID: NCT03528694 Not yet recruiting - Clinical trials for Non-muscle-invasive Bladder Cancer

Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer

POTOMAC
Start date: May 31, 2018
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multi-center, global, phase III study to determine the efficacy and safety of Durvalumab + BCG combination therapy in the treatment of patients with non-muscle-invasive bladder cancer.

NCT ID: NCT03527446 Not yet recruiting - Obesity Clinical Trials

Acute and Chronic Metabolic Flexibility in Individuals Living With Obesity: The i-FLEX Study

i-FLEX
Start date: May 2018
Phase: N/A
Study type: Interventional

Regular exercise is a cornerstone in the prevention and the management of cardio-metabolic risk factors. Some of the beneficial effect of exercise training occurs through metabolic flexibility' enhancement. Metabolic flexibility is the ability to respond or adapt to conditional changes in metabolic demand, and previous literature has shown that individuals living with obesity have an impaired metabolic flexibility compared to lean individuals. However, there is a lack of empirical evidence on the impact of sprint interval training on metabolic flexibility and whether this translates into clinically meaningful outcomes. This study will evaluate the impact of 4-week sprint interval training in normal weight individuals as well as individuals living with obesity on acute and chronic metabolic flexibility, irisin secretion and insulin sensitivity.

NCT ID: NCT03527394 Recruiting - Pediatric Obesity Clinical Trials

Motivation to Change Lifestyle Habits in Youth With Obesity

RMI-Family
Start date: November 6, 2017
Phase:
Study type: Observational

Approximately one-third of Canadian children have excess weight, putting them at increased risk of type 2 diabetes, cardiovascular disease, bone and joint problems, and some forms of cancer. Because current therapies for managing obesity have modest success, there is a need to develop and test innovative strategies to enhance pediatric weight management. Using a novel interview designed to measure motivation to change lifestyle habits, we will conduct separate and structured 1-on-1 interviews with youth with obesity and parents. By applying principles of motivational interviewing, our trained interviewers will ask youth and their parents about their motivation to change lifestyle habits related to diet and physical activity. Subsequently, interview data will be used to examine predictors of clinically-meaningful outcomes over time, including changes in weight status, lifestyle habits, health care utilization, and attrition. We will also measure a number of variables related to weight management, including dietary intake, physical activity, anthropometry, and psychosocial health.

NCT ID: NCT03526952 Recruiting - Colorectal Cancer Clinical Trials

An Internet Delivered Intervention for Re-Adjustment to Sexual Intimacy With a Permanent Ostomy After Colorectal Cancer

Start date: May 4, 2018
Phase: N/A
Study type: Interventional

This study investigates the feasibility and efficacy of an Internet-delivered intervention for the sexual and intimate re-adjustment of couples in which one partner is living with a permanent ostomy (e.g., colostomy, ileostomy) following treatment for colorectal cancer. The two session intervention will be delivered via online videoconferencing and will focus on facilitating couples' communication around their sexual and intimate relationship. Exercises from sex therapy will be used to scaffold conversations about motivations for having sex, intimacy and sensual pleasure, and relational strengths for coping. The intervention aims to enhance couples' ability to cope with the changes in their sexual and intimate relationship. A group of couples receiving written educational material only will be used as a comparison group to measure change in sexual and intimate adjustment over time .

NCT ID: NCT03526510 Recruiting - Prostate Cancer Clinical Trials

Hypofractionated Boost vs Conventionally Fractionated Boost for Localized High Risk Prostate Cancer

Start date: June 2011
Phase: N/A
Study type: Interventional

Randomized trial comparing 2 external beam radiotherapy fractionation schemes in patients with localized high risk prostate cancer. Primary endpoint is acute toxicity.

NCT ID: NCT03525379 Recruiting - Clinical trials for Congestive Heart Failure Chronic

Evaluating the Clinical Efficacy of Resveratrol in Improving Metabolic and Skeletal Muscle Function in Patients With Heart Failure

REV-HF
Start date: October 26, 2017
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled trial evaluating the effect of resveratrol on metabolic and skeletal muscle function. Patients will be randomized and allocated to either resveratrol or placebo, for 8 weeks with a 2-week run-in period before the intervention period (to ensure they are not on any nutritional supplement that contains resveratrol).

NCT ID: NCT03525197 Not yet recruiting - Clinical trials for Skeletal Muscle Hypertrophy

Effects of a Multi-ingredient Supplement Study: a Randomized Controlled Trial in Men and Women

SRCT
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

Resistance exercise training is a known stimulant for muscle protein synthesis (MPS) to occur, however the consumption of protein is also necessary to induce a shift towards a positive net protein balance. Other nutrients have been shown to be useful in the accretion of lean body mass and strength. Whey protein has been shown to improve muscle net protein balance after resistance exercise, more so when in conjunction with creatine. Furthermore, essential amino acids such as Leucine have been found to be important in moderating the shift towards a positive net protein balance, especially post-exercise and in combination with whey protein. Other vitamins and minerals have been shown to aid in permitting muscle protein synthesis rather than stimulating it, but are still necessary for optimal gains in hypertrophy. The effect of a multi-ingredient compound has rarely been investigated, and thus this study aims to combine whey protein, leucine, creatine, calcium citrate and vitamin D and test it in a resistance exercise training program over 12 weeks. Another novel aspect in this study will be testing this supplement against a placebo of equal amounts of protein and amino acids, the placebo will contain collagen protein and the non-essential amino acids alanine and glycine. Finally, this study will recruit both men and women (ages 18-30) to determine possible effects of the supplement on muscle hypertrophy in both sexes. We hypothesize that the synergistic effect of the ingredients in our supplement will induce hypertrophy to a larger degree than resistance exercise training with the placebo, and that these benefits will persist in both male and female participants.

NCT ID: NCT03524495 Recruiting - Clinical trials for Cognitive Function 1, Social

Well-being of Shelter Guests in Vancouver

Start date: March 5, 2018
Phase: N/A
Study type: Interventional

This study will primarily investigate the impacts of a one-time unconditional cash transfer on the well-being of recently homeless individuals. Secondary research questions will examine the impact of personal coaching for cash recipients and the impact of a workshop and coaching intervention for non-cash recipients.