Investigating the feasibility of a combined exercise and nutrition prehabilitation program for women with endometrial cancer scheduled for surgery

Not Applicable

• Conditions: Endometrial cancer; Cancer - Womb (Uterine or endometrial cancer)

• Registration Number: ACTRN12624000166572
• Lead Sponsor: King Edward Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-02-22
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility[- Recruitment rate (defined as the number of patients consenting, divided by the number of eligible patients approached to participate). Data to determine recruitment rate will be collected from the study screening log, which will contain information on eligibility and enrolment (or not) of all screened patients.<br>- Retention rate (determined by the number of participants who completed the pre- and post-intervention testing). Data to determine retention rate will be collected from the study enrolment log, which will contain data collected at different time points during the study from all participants. Study withdrawals will be indicated in this document.<br>The intervention will be deemed feasible if the recruitment rate is 50% and the retention rate is 60%.<br>Both measures will be assessed as a composite primary outcome. Every three months for the duration of the recruitment period, i.e., till 20 participants are recruited.]