Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

All Drugs and Chemicals

Androgens

Informational initiation lecture and supervised exercise twice a week for 12 weeks followed by 12 weeks of non-supervised exercise.

Informational initiation lecture and only non-supervised exercise

12 weeks of progressive weight training twice a week supervised by a qualified physiotherapist.

Progressive supervised weight training

Urologist informs participants on adverse effects of castration treatments and benefits of regular exercise. Physiotherapist gives an exercise program to follow at home, and nutritionist informs patients on correct nutrition to assist physical exercise.

Lecture

Teemu Murtola, MD PhD

Teuvo Tammela, MD PhD

Teemu Murtola, MD, PhD

Lauri Rantaniemi

Jarno Riikonen, MD PhD

Hanna Ojala, PhD

Ilkka Pietilä, PhD

Teuvo LJ Tammela, MD PhD

This study evaluates effects of supervised exercise in reducing adverse effects of hormonal treatment, increasing quality of life and in inducing a long-term change into more active lifestyle in prostate cancer patients on androgen deprivation therapy. All participants will attend a starting lecture at the beginning of the trial, after which they are randomly allocated to attend 3 months of either supervised or non-supervised exercise program. Leisure time activity, quality of life, blood sugar and cholesterol values, and body composition of participants will be evaluated at three time-points; at recruitment, after 12 weeks and after 24 weeks. Effects on quality of life will also be qualitatively evaluated with single- and group interviews.

Androgen deprivation therapy (ADT) is commonly used in management of advanced or recurrent prostate cancer. It also frequently used adjuvant to curative-intent radiation therapy for localized prostate cancer. Low testosterone levels during androgen deprivation commonly cause adverse effects reducing quality of life. Most common adverse effects include fatigue, weight gain, loss of lean muscle mass, hyperglycemia and hypercholesterolemia.

Regular exercise, especially programs involving combination of both aerobic exercise and resistance training has been shown to reduce to reduce adverse effects of ADT on physical functioning and quality of life. It may also improve disease prognosis.

The study compares effects of supervised and unsupervised exercise on plasma lipid parameters (total cholesterol, LDL, HDL and triglycerides) and glucose levels (fasting plasma glucose, glycated hemoglobin), overall quality of life and on average daily exercise activity in men with prostate cancer and under ADT. As secondary outcome we will study effect on continued exercise activity after the intervention, changes in body composition, blood pressure and risk of fractures, castration resistance as well as death due to prostate cancer and due to any cause.

Study hypothesis is that supervised exercise will improve quality of life, lipid and glucose parameters and increase daily exercise activity more that non-supervised exercise. We also expect higher continued exercise activity, greater changes in body composition and blood pressure and lowered risk of fractures and death in the supervised exercise group.

This is a randomized, controlled clinical trial. The study aims to recruit 40 men on ADT for prostate cancer. This will be a pilot study to estimate effect sizes in Finnish population to inform further larger trial.

All participants attend introductory lecture, where a urologist informs them about adverse effects of ADT and positive effects of exercise during ADT, exercise instructor gives advice for training both at home and in the gym and nutritional therapeutist tells about nutrition to overcome adverse effects of ADT and support training.

After the introductory lecture the participants are randomized 1:1 to either the supervised or non-supervised exercise group (Figure). Men in the supervised group participate in progressive group exercise sessions twice a week for total of 12 weeks at the Varala sports academy in Tampere, Finland. Each exercise session includes both aerobic and resistance training targeting all major muscle groups (Additional document I, exercise program). The non-supervised group will exercise independently for 12 weeks according to the instructions given at the introductory lecture. The first control visit will be after this first period of 12 weeks of exercise.

After the first follow-up visit both group will continue non-supervised exercise for 12 weeks, after which the second control visit will be arranged. Special focus on the second control visit is to see how many in each group has been able to carry on active exercising, i.e. has the intervention promoted long-term change in exercise activity.

Both study group will be given Polar wrist activity monitors to be used 24 h/day for the entire course of the study.

All participants are asked to fill validated quality of life surveys EORTC QLQC-30 (overall quality of life) and EORTC QLQC-PR25 (prostate cancer-specific quality of life) at baseline and again at 1st and 2nd control visits. Additionally, qualitative evaluation of quality of life as well as perceived possibilities and obstacles for exercise are evaluated in individual- and group interviews during the study visits. Plasma lipid and glucose parameters, blood pressure and body composition will be measured at each of these visits.

At each visit a separate blood sample is taken and stored for future measurement of biomarkers associated with prostate cancer progression, glucose and lipid metabolism and effects of exercise.

Participant will be randomized 1:1 to either supervised exercise for 12 weeks or to follow given exercise program on their own.

Exercise and Quality of Life During Androgen Deprivation Therapy

Exercise Intervention to Reduce Adverse Quality of Life Effects From Androgen Deprivation Therapy for Prostate Cancer - Randomized Clinical Trial

IPD will not be shared since it is prohibited by the ethics board and by patient consent

Time to castration resistance as defined by two consecutive rising PSA levels and increase of 50% or more from the nadir. Measured as months between the study recruitment and first record of castration resistance. Information obtained from patient files.

Time to death due to any cause. Measured as months between the study recruitment and date of death. Information obtained from patient files and national death certificate registry.

Time to death due to prostate cancer. Measured as months between the study recruitment and date of death. Information obtained from patient files and national death certificate registry.

Occurrence of any bone fracture requiring either conservative or operative management. Information obtained from patient files and national hospital discharge registry. Fracture site and it's management are recorded.

Daily activity as measured by wrist activity monitor worn by the participants at all times during the study. Measured as metabolic equivalents of task (MET) units. Range from 0.9 to 23.

Score from validated survey EORTC QLQ-C30, score range from 0-100, with 100 denoting the highest quality of life

Score from validated survey EORTC QLQ-PR25, score range from 0-100, with 100 denoting the highest quality of life

Change in daily activity of the supervised exercise group after completion of 12 weeks of supervised exercise as measured by wrist activity monitor in MET units, range from 0.9 to 23.

The effect of supervised exercise on subjective adverse effects of castration treatment for prostate cancer. Qualitative assessment in three individual interviews and one group interview. No scaling used as this is a qualitative rather than quantitative end-point

Bioimpedance-based measurement of lean body mass as percentage of total body mass measured with TANITA MC-780 device

Bioimpedance-based measurement of muscle mass as percentage of total body mass measured with TANITA MC-780 device

Bioimpedance-based measurement of skeletal mass as percentage of total body mass measured with TANITA MC-780 device measured with TANITA MC-780 device

Bioimpedance-based measurement of fat mass as percentage of total body mass measured with TANITA MC-780 device measured with TANITA MC-780 device

Metabolic age measured with bioimpedance-based TANITA MC-780 device

Varalan urheiluopisto

Tampere University Hospital

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

No intervention

Ji Yong Ahn, M.D., PhD.

Eun Jeong Gong, M.D.

Hwoon-Yong Jung, M.D., PhD.

Investigators have a plan to conduct nested case-control study to investigate the association between serum cholesterol levels including TC, HDL-C, LDL-C, triglyceride (TG), apolipoproteins and gastric neoplasm. In addition, further analyses were performed to evaluate the possible role of the serum cholesterol as a predictor for the differentiation and prognosis of gastric neoplasm.

Although its incidence has declined, gastric cancer remains one of the most common causes of cancer morbidity and mortality worldwide.Since the stage of gastric cancer at the time of detection correlates with prognosis, secondary prevention is important. Screening of asymptomatic individuals for gastric cancer has been shown to increase the detection of early gastric cancer (EGC), which has a 5-year overall survival (OS) rate exceeding 90%.

Gastric carcinogenesis is a multi-factorial process that includes environmental, socioeconomic, and lifestyle factors. Many of risk factors, including dietary factors, chronic atrophic gastritis, intestinal metaplasia, and H. pylori infection, alcohol consumption, and aspirin have been investigated. Although the specific correlation between serum cholesterol and gastric cancer is not fully understood, inverse relationships have been observed between serum total cholesterol (TC) levels and cancer, and recent analyses of randomized controlled trials showed significant inverse associations between high density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C) and the risk of incident cancers. Lower lipoprotein cholesterol in cancer patients may be due to the enhanced activity of the lipoprotein cholesterol receptor pathway and to the increased demand for cholesterol during tumor development and lymphatic spread. Some suggested that the preexisting tumor might have resulted in low serum cholesterol, which is called "preclinical cancer effect" or "unsuspected sickness". In another study, LDL-C has been reported to affect host immune system cells.

In our previous study, investigators found that serum HDL-C and LDL-C levels were associated with the risk, resectability, and prognosis of gastric cancer. There are several cohort studies reported that low serum cholesterol levels are associated with incident cancer, including gastric cancer. However, most studies regarding the serum cholesterol and gastric cancer investigated gastrectomized patients, and showed the association between low serum cholesterol levels and lymph node metastasis or submucosal invasion. Furthermore, there are only few studies evaluated the association between LDL-C of apolipoproteins and gastric cancer. Therefore investigators conducted nested case-control study to investigate the association between serum cholesterol levels including TC, HDL-C, LDL-C, triglyceride (TG), apolipoproteins and gastric neoplasm. In addition, further analyses were performed to evaluate the possible role of the serum cholesterol as a predictor for the differentiation and prognosis of gastric neoplasm.

endoscopic biopsy specimen of gastric mucosa surgically resected specimen of stomach

Serum Cholesterol and Gastric Neoplasm

Serum Cholesterol and Gastric Neoplasm: Nested Case-control Study

Serum cholesterol levels including TC, HDL-C, LDL-C, triglyceride (TG), apolipoproteins will be checked and compared in paitents with and withoutgastric neoplasm.

1. Degree of decresed serum cholesterol levels including TC, HDL-C, LDL-C, triglyceride (TG), apolipoproteins in patients with gastric neoplasm compare to the patients without gastric neoplasm.
2. Degree of decresed serum cholesterol levels including TC, HDL-C, LDL-C, triglyceride (TG), apolipoproteins in patients with gastric neoplasm according to the stage of gastric neoplasm.

Asan Medical Center

Professor

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Breast Neoplasms

Pain

Cough

Chronic Cough

Chronic Graft Versus Host Disease

Oculocerebral Syndrome With Hypopigmentation

Lipid Regulating Agents

Bone Density Conservation Agents

Rosuvastatin Calcium

Calcium

Calcium, Dietary

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Enzyme Inhibitors

Healthy adults from USA receive a single dose of rosuvastatin (interaction drug) in Period 1.

The healthy adults from Period 1 receive both rosuvastatin + BAY1817080 in Period 2.

Single dose of 5 mg rosuvastatin is administered as tablet orally on Day 1 of Period 1 (total length = 5 days).

Rosuvastatin

A single dose of 5 mg rosuvastatin tablets is administered on Day 8 of Period 2 (total length = 15 days). BAY1817080 is administered as tablets twice daily on Days 1 to 14 of Period 2.

Rosuvastatin + BAY1817080

Researchers in this study want to learn how the study drug BAY1817080 interacts with another drug called rosuvastatin (brand name: Crestor) and affects the way the body absorbs, distributes and excretes rosuvastatin in healthy adult male and female participants (drug-drug interaction study). The study drug BAY1817080 is a new drug under development with a goal to suppress pain and chronic cough. It works by binding to and blocking proteins related to pain in the body. Rosuvastatin is an approved and marketed drug to lower high levels of "bad" cholesterol (a waxy, fat-like substance found in blood). Both drugs interact with the same proteins (molecules) in the human body, and as a result, the study drug may affect the way rosuvastatin is taken up and used by the body when applied together.

Participants in this study will be asked to visit the clinic 3 times over a period of 3 to 4 weeks. Each participant will receive rosuvastatin tablets twice with at least 11 days in between and the study drug tablets twice daily for 14 days. Blood samples will be taken from the participants to measure the blood levels of rosuvastatin.

The primary objective of the study is to investigate the influence of multiple doses of BAY1817080 on the pharmacokinetics of rosuvastatin given concomitantly. Secondary objective is to investigate the safety of BAY1817080.

Study to Learn the Effect of Drug BAY1817080 on the Way the Body Absorbs, Distributes and Excretes Another Drug Rosuvastatin in Healthy Adult Participants

Open Label, Fixed Sequences, One-way Cross-over Study to Determine the Effects of Multiple Doses BAY1817080 (150 mg) on the Pharmacokinetics of a 5 mg Dose Rosuvastatin in Healthy Participants

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Bayer

Recurrence

Disease Progression

Disease Attributes

Atorvastatin

Capsules of atorvastatin. Daily dose of 80 mg for max. 10 years or until development of castration resistance.

Identical capsules as in the atorvastatin arm, but including no active ingredient. Used daily for max. 10 years or until development of castration resistance

Atorvastatin 80mg

Similar capsules as in the atorvastatin arm, but without the active ingredient

Placebo oral capsule

Aino Siltari, PhD

Mikkel Fode, MD, PhD

Peter Oestergren, MD, PhD

Andres Kotsar, MD, PhD

Antti Rannikko, MD,PhD

Heikki Seikkula, MD, PhD

Arto Salonen, MD,PhD

Timo Marttila, MD,PhD

Otto Ettala, MD, PhD

Rasmus Nilsson, MD, PhD

Sven Lofferen, MD, PhD

Heikki Seikkula

This randomized double-blind placebo-controlled trial tests whether intervention with atorvastatin delays development of castration resistance compared to placebo during androgen deprivation therapy (ADT) for prostate cancer.

Cholesterol-lowering statin drugs have been reported to lower proliferation activity in prostate cancer, delay occurrence of castration resistance and reduce the risk of prostate cancer death. Therefore, it is important to test statins' efficacy in addition to conventional prostate cancer treatment in a randomized, placebo-controlled trial.

This phase 3 randomized double-blind placebo-controlled trial will explore whether intervention with atorvastatin delays prostate cancer progression i.e. development of castration resistance compared to placebo during androgen deprivation therapy (ADT) for metastatic or recurrent prostate cancer.

Secondary objectives include exploring whether atorvastatin lowers prostate cancer-specific or overall mortality compared to placebo, and to demonstrate whether changes in serum lipid parameters predict disease recurrence and occurrence of adverse genomic changes predicting castration resistance among prostate cancer patients during ADT.

The study recruitment target is 400 participants who start ADT as management of metastatic or recurrent prostate cancer. These men will be randomized 1:1 (200 + 200) to receive blinded study drug, either 80 mg of atorvastatin daily or placebo until disease recurrence i.e. development of castration resistance or for a maximum of five years.

The study will be carried out in collaboration between urological departments of University Hospitals in Finland as a project of the national FinnProstata study group, Herlev University Hospital in Denmark, Vestfold and Telemark hospitals in Norway and the Tartu University Hospital in Estonia.

Follow-up is continued until the primary end-point, development of castration resistance. After this the participants will be given the opportunity to voluntarily carry on with the blinded intervention for maximum time of ten year to observe effects on survival after development of castration resistance. Blinding will be lifted after the follow-up is complete for all study participants.

Castration resistance is defined as prostate-specific antigen (PSA) progression (three consecutive rises of PSA measured at least 1 week apart with two \> 50% increases over the nadir and PSA \> 2 ng/ml) or radiological disease progression (appearance of two or more lesions in bone scan or soft tissue enlargement as per RECIST criteria) with serum testosterone at castrate level (\< 1.73 nmol/l; 50 ng/dl) during ADT.

Impact of Atorvastatin on Prostate Cancer Progression During ADT

Impact of Atorvastatin on Prostate Cancer Progression After Initiation of Androgen Deprivation Therapy - Lipid Metabolism as a Novel Biomarker to Predict Prostate Cancer Progression

Sharing of individual-level data is not allowed by ethics board

Castration resistance is defined as PSA progression (three consecutive PSA rises measured at least 1 week apart with two \> 50% increases over the nadir and PSA \> 2 ng/ml) or radiological disease progression (appearance of two or more lesions in bone scan or soft tissue enlargement as per RECIST criteria) with serum testosterone at castrate level (\< 1.73 nmol/l; 50 ng/dl) during ADT.

Change in serum lipid levels during the intervention. Measured at baseline and in every follow-up visit. Results are blinded from the investigators and participants before the final analysis

Followed through Finnish national registries after reaching the primary end-point

Occurrence of adverse tumor traits predicting development of castration resistance in circulating cell free DNA

To see how ADT affects glucose tolerance and whether atorvastatin intervention has any effect on it

Any cardiovascular events as described by the participant or evident from the patient files during the course of follow-up. Followed via national registries after meeting the primary end-point.

Score from validated QOL questionnaire EORTC QLQ-C30 (range 0-100, with 100 denoting highest quality of life)

Score from validated QOL questionnaire EORTC QLQ-PR25 (range 0-100, with 100 denoting highest quality of life)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Exercise and Quality of Life During Androgen Deprivation Therapy	NCT04050397	Prostate Cancer	Progressive sup... Lecture	18 Years -	Tampere University Hospital
Serum Cholesterol and Gastric Neoplasm	NCT02041312	Gastric Cancer	No intervention	-	Asan Medical Center
Study to Learn the Effect of Drug BAY1817080 on the Way the Body Absorbs, Distributes and Excretes Another Drug Rosuvastatin in Healthy Adult Participants	NCT04252300	Drug Interactio...	Rosuvastatin Rosuvastatin + ...	18 Years - 55 Years	Bayer
Impact of Atorvastatin on Prostate Cancer Progression During ADT	NCT04026230	Metastatic Pros... Recurrent Prost...	Atorvastatin 80... Placebo oral ca...	18 Years -	Tampere University Hospital

Spots Global Cancer Trial Database for cholesterol

Every month we try and update this database with for cholesterol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cholesterol

Every month we try and update this database with for cholesterol cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cholesterol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.