Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000166572
Ethics application status
Approved
Date submitted
17/01/2024
Date registered
22/02/2024
Date last updated
22/02/2024
Date data sharing statement initially provided
22/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the feasibility of a combined exercise and nutrition prehabilitation program for women with endometrial cancer scheduled for surgery
Scientific title
A pilot study to investigate the feasibility of a combined exercise and nutrition prehabilitation program for patients with endometrial cancer scheduled for surgery
Secondary ID [1] 311293 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial cancer 332532 0
Condition category
Condition code
Cancer 329225 329225 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 327753 0
Treatment: Surgery
Intervention code [2] 327754 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337078 0
Feasibility
Timepoint [1] 337078 0
Every three months for the duration of the recruitment period, i.e., till 20 participants are recruited.
Secondary outcome [1] 430592 0
Anthropometry
Timepoint [1] 430592 0
At the start and end of the intervention (6 weeks post-commencement).
Secondary outcome [2] 430593 0
Physical function
Timepoint [2] 430593 0
At the start and end of the intervention (6 weeks post-commencement)
Secondary outcome [3] 430594 0
Health-related quality of life
Timepoint [3] 430594 0
At the start and end of the intervention (6 weeks post-commencement), and six-weeks post-surgery
Secondary outcome [4] 430595 0
Quality of recovery from surgery
Timepoint [4] 430595 0
Day prior to surgery and Day 1 post-surgery
Secondary outcome [5] 430767 0
Anaesthetic/perioperative outcomes
Timepoint [5] 430767 0
Post-surgery
Secondary outcome [6] 430768 0
Surgical outcomes
Timepoint [6] 430768 0
Post-surgery

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The sample size for this interventional, single-arm proof of concept study is pragmatic, and analysis will be descriptive. Data analysis will be performed using the statistical software IBM SPSS Statistics Version 27.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
28/02/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26012 0
King Edward Memorial Hospital - Subiaco

Funding & Sponsors
Funding source category [1] 315548 0
Hospital
Name [1] 315548 0
King Edward Memorial Hospital
Country [1] 315548 0
Australia
Primary sponsor type
Hospital
Name
King Edward Memorial Hospital
Address
374 Bagot Road, Subiaco, Western Australia, 6008
Country
Australia
Secondary sponsor category [1] 317634 0
University
Name [1] 317634 0
Edith Cowan University
Address [1] 317634 0
270 Joondalup Drive, Joondalup, Western Australia, 6027
Country [1] 317634 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314447 0
Women and Newborn Health Service Ethics Committee
Ethics committee address [1] 314447 0
374 Bagot Road, Subiaco, Western Australia, 6008
Ethics committee country [1] 314447 0
Australia
Date submitted for ethics approval [1] 314447 0
31/01/2023
Approval date [1] 314447 0
07/03/2023
Ethics approval number [1] 314447 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131614 0
Prof Paul A. Cohen
Address 131614 0
Department of Gynaecological Oncology, West Wing Clinic, 374 Bagot Road, Subiaco, Western Australia, 6008
Country 131614 0
Australia
Phone 131614 0
+61 8 9468 5188
Fax 131614 0
Email 131614 0
paul.cohen@health.wa.gov.au
Contact person for public queries
Name 131615 0
Prof Paul A. Cohen
Address 131615 0
Department of Gynaecological Oncology, West Wing Clinic, 374 Bagot Road, Subiaco, Western Australia, 6008
Country 131615 0
Australia
Phone 131615 0
+61 8 6458 2222
Fax 131615 0
Email 131615 0
paul.cohen@health.wa.gov.au
Contact person for scientific queries
Name 131616 0
Prof Paul A. Cohen
Address 131616 0
Department of Gynaecological Oncology, West Wing Clinic, 374 Bagot Road, Subiaco, Western Australia, 6008
Country 131616 0
Australia
Phone 131616 0
+61 8 6458 2222
Fax 131616 0
Email 131616 0
paul.cohen@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.