None listed
Conditions
Brief summary
The main aim of this research is to test the feasibility of a six-week combined exercise and nutrition intervention delivered to endometrial cancer patients before surgery. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with early stage endometrial cancer and you have an identified surgical risk factor including being overweight, having high blood pressure and/or high cholesterol, and/or type 2 diabetes. Study details All participants who choose to enrol in this study will be prescribed an exercise regime to follow for 6 weeks prior to their scheduled surgery to remove their cancer. The exercise regime will involve one weekly session with an exercise physiologist and two sessions at home, as well as a target level of exercise to complete each day, which may include walking/running, cycling or swimming. Participants will also be given options to follow a diet plan for six weeks prior to their surgery or to use Optifast products as meal replacements if it is safe for them to do so. It is hoped this research will provide important information to help endometrial cancer patients better tolerate the physical challenges of surgery and enhance their post-surgery recovery. If this study shows positive effects on post-surgery recovery, a larger trial enrolling a greater number of participants may be undertaken in the future.
Interventions
Length of intervention: 6 weeks Exercise: The exercise component involves both aerobic and resistance exercise. Resistance exercise sessions will take place three times per week. Participants will be provided with elastic bands and will be asked to do a combination of upper and lower body exercises, such as sit-to-stands, standing rowing and standing chest press with the elastic band. Each session will be approximately 30 minutes long. One of these weekly sessions will take place in the gym at the King Edward Memorial Hospital (Perth, Western Australia) and will be supervised by an accredited exercise physiologist from the Edith Cowan University Exercise Medicine Research Institute. Two of the sessions each week will not be supervised and will take place in participants’ homes. The exercise physiologist will inform participants each week about the type, volume and intensity of resistance exercises to be done at home. In addition to the resistance exercise sessions, participants will be asked to do 20 to 30 minutes of aerobic exercise such as walking, cycling, or swimming, three times per week. The amount of aerobic exercise will be designed specifically for participants, based on physical ability, during contact sessions with the exercise physiologist. Participants can break up their aerobic exercise into shorter bouts (of 10 - 15 min) throughout the week. To determine adherence and compliance, participants will be asked to keep a record of their home-based exercise in a logbook that will be provided to them by the exercise physiologist. Nutrition: The nutrition component involves education and support from the Department of Nutrition and Dietetics at King Edward Memorial Hospital. During their initial visit (seven weeks before surgery), participants will meet a dietician with oncology experience when they attend the Gynaecological Oncology Outpatient Clinic at King Edward Memorial Hospital. Participants will be offered the choice of either: 1. A very low calorie pre-operative diet with Optifast, a nutritionally complete very low-calorie program to help rapid, safe weight loss in the weeks prior to their surgery. Optifast is a safe dietary preparation that provides 800 kcal per day. Optifast products in the form of shakes, soups, desserts, or bars replace regular main meals in addition to a minimum of 2 cups of low starch vegetables per day. It works by helping to reduce appetite and can help patients to lose 1.0 - 2.5kg per week. It can also lead to improvements in blood pressure, cholesterol, and blood sugar control. This option is not suitable for women over 65 years of age or for those with Type I diabetes. Participants choosing this option will need to pay for the Optifast themselves. 2. A low-calorie diet (1200 kcal per day). The Dietician will provide education, meal plans and recipes to assist with following a 1200 calorie diet for weight loss. This will be tailored to individual patients’ current dietary preferences and habits. 3. Tailored healthy eating strategies for weight loss. The Dietitian will assess current dietary intake and make suggestions for changes to assist with reduced calorie intake and healthier eating. Participants will be asked to follow the nutrition plan of their choice until the day prior to their surgery (six to seven weeks) and to record their food intake in a food diary. The dietician will provide ongoing support to all participants with weekly telephone consultations until the time of their surgery.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Low grade (grade 1) endometrioid endometrial adenocarcinoma 2. Presumed early stage (Federation of Gynecology and Obstetrics stage 1A) on physical examination and imaging (CT chest, abdomen, and pelvis) 3. At least one of the following cardiovascular risk factors: overweight (BMI greater than or equal to 25kg/m2) or obese (BMI greater than or equal to 30kg/m2), hypertension, type 2 diabetes, hypercholesterolaemia, self-reported physical inactivity (less than 150 minutes per week of moderate activity such as walking, gardening, swimming, cycling, gym), smoking 4. Planned to undergo definitive surgery (total hysterectomy, bilateral salpingo- oophorectomy +/- sentinel lymph node biopsies) 5. Age 18 years or older 6. Able to understand study requirements, attend regular appointments with the exercise physiologist and dietitian, and complete the home exercise logbook 7. European Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Exclusion criteria
1. Medical contraindication to exercise or the use of a very low-calorie diet, including physical impairments, lactation, presence of porphyria, severe hepatic disease, advanced renal disease, unstable cardiac disease (recent myocardial infarction or unstable angina), type 1 diabetes mellitus, overt psychosis, alcoholism, or drug abuse 2. Patients on lithium, corticosteroids, anticonvulsants (although not a contraindication to Optifast, requires extra monitoring beyond the scope of this study) 3. Evidence of extra-uterine disease clinically or on medical imaging 4. Histological cell types including serous, clear cell, carcinosarcoma, sarcoma, de- differentiated 5. Moderately differentiated or poorly differentiated (grades 2 and 3) endometrioid adenocarcinoma 6. Grade 1 endometrioid adenocarcinoma where the treatment plan is for fertility preservation/conservative management 7. Inability to give informed consent 8. European Cooperative Oncology Group (ECOG) performance status greater than or equal to 3