This work involved prospective study of surgical patients receiving TPN during the calendar year of 2013 at Cancer Hospital.

Jincheng Yang, Doctor

The purpose of this study is to determine the relationship among TPN, tumor and blood glucose.

Select the tumor patients in abdominal department after surgery with TPN. Monitor the blood glucose variation after TPN.

Study on Blood Glucose Variations in Tumor Patients Before and After Total Parenteral Nutrition

Phase 1: Select Tumor Patients to be Observed Phase 2: Observe the Blood Glucose Values During TPN Phase 3: Sort Data

Observe the blood glucose variation in tumor patients after surgery. According to the TPN infusion time, the blood glucose values are divided into three parts: pre TPN, within 24h and after 24h.

Chinese Academy of Medical Sciences

pharmacist

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

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Diabetes Mellitus

Pancreatic Neoplasms

Endocrine System Diseases

Metabolic Diseases

Glucose Metabolism Disorders

Pancreatic Cancer

Hypoglycemic Agents

Metformin

Insulin

Insulin, Globin Zinc

1. For patients with new-onset diabetes Fasting blood glucose 7-10 mmol/L, metformin 2 g/day, BID, PO; Fasting blood glucose 10-14 mmol/L, metformin 1 g/day, BID, PO, Novolin 30R Penfil 12 U before breakfast, 8 U; Fasting blood glucose \> 14 mmol/L, metformin 1 g/day, BID, PO, Novolin 30R Penfil 16 U before breakfast, 10 U; Adjusting insulin dosage according to the monitor of fasting blood glucose.
2. For patients with history of diabetes Adjusting metformin or insulin dosage according to the monitor of fasting blood glucose.

Metformin or insulin treatment

Guopei Luo, M.D., Ph.D.

About 80% of patients with pancreatic adenocarcinoma have aberrant fasting blood glucose at the time of diagnosis. The consistent association between pancreatic cancer and diabetes mellitus has long been recognized and even been termed as "chicken and egg". Many reports have found that pancreatic cancer can result in diabetes, which is called type 3c diabetes. New-onset diabetes is commonly observed in pancreatic cancer patients and has been considered as a potential screening sign. Moreover, diabetes has been found as a predictor of poor outcome in pancreatic cancer.

Pancreatic cancer cells have a strong dependence on glucose and they are well-known for their sweet teeth. High glucose is associated with impaired immunologic reaction, intolerability to chemotherapy, radiotherapy and other major treatments, an increased risk of pancreatic surgery. Given the linkage between pancreatic cancer and diabetes or high blood glucose, a clinical trial is needed to validate the effect of metformin and insulin on regulating blood glucose in type 3c diabetes.

Metformin and Insulin to Pancreatic Cancer Related Diabetes (Type 3c)

Administration of Metformin and Insulin to Pancreatic Cancer Related Diabetes Mellitus (Type 3c)

Change of tumor biomarkers before and after anti-diabetic administration.Patients will collect CA19-9 values on the day of enrollment and on day 8.

OS of subjects from recruiting to the time of death from any cause

Blood glucose control rate before and after anti-diabetic administration

HbA1C control rate before and after anti-diabetic administration

Fudan University

Professor

Symptoms and General Pathology

Overweight

Obesity

Overnutrition

Nutrition Disorders

Body Weight

consume both high and low glycemic load diets for 28 days each

Low Glycemic Load Diet

High Glycemic Load Diet

Marian Neuhouser, RD, PhD

This study is designed to investigate associations of low- and high-glycemic load diets with biomarkers of hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk.

This is a randomized, crossover feeding study conducted in normal weight and overweight individuals. Participants will be given all their food to eat and drink (except water) for two 28-day feeding periods (a total of 56 days). The diets will be carefully controlled and energy intake will be regulated to maintain weight stability for each participant. The two feeding periods will be separated by a 28 day "washout" period when participants will eat their own food. Dinner will be eaten at the Hutchinson Center Monday through Friday. Each evening, breakfast, lunch and snacks will be brought home for the next day. On Friday evenings all the food will be taken home for the weekend.

Samples of blood will be collected after an overnight fast at the beginning and the end of each feeding period. All urine will be collected for 24 hours at the end of each feeding period. A number of questionnaires will also be completed during each diet period. A small stool sample will be collected in your own home, before the first feeding period, and once during each feeding period. The stool sample collection is optional. One can decide not to provide a stool sample and still participate in the study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study on Blood Glucose Variations in Tumor Patients Before and After Total Parenteral Nutrition	NCT02024321	Cancer Surgery Nutrition Relat...		-	ChineseAMS
Exercise and Quality of Life During Androgen Deprivation Therapy	NCT04050397	Prostate Cancer	Progressive sup... Lecture	18 Years -	Tampere University Hospital
Metformin and Insulin to Pancreatic Cancer Related Diabetes (Type 3c)	NCT05306028	Pancretic Cance... Diabete Mellitu...	Metformin or in...	18 Years - 80 Years	Fudan University
Carbohydrates and Related Biomarkers	NCT00622661	Healthy Overweight	Low Glycemic Lo... High Glycemic L...	18 Years - 45 Years	Fred Hutchinson Cancer Center
Carbohydrates and Related Biomarkers	NCT00622661	Healthy Overweight	Low Glycemic Lo... High Glycemic L...	18 Years - 45 Years	Fred Hutchinson Cancer Center
Metformin and Insulin to Pancreatic Cancer Related Diabetes (Type 3c)	NCT05306028	Pancretic Cance... Diabete Mellitu...	Metformin or in...	18 Years - 80 Years	Fudan University

Spots Global Cancer Trial Database for blood glucose