None listed
Conditions
Brief summary
The aim of this study is to determine the enduring effects on survivorship of an exercise intervention administered in addition to usual care, compared to usual care alone, during first-line chemotherapy for epithelial ovarian, primary peritoneal and fallopian tube cancer. Woman aged 18 years or above, who have been newly diagnosed with epithelial ovarian, primary peritoneal or fallopian tube cancer of any histological type and are suitable for first-line chemotherapy are eligible to participate in this study. Participants are randomly allocated (by chance) to one of two groups. Participants in one group will receive a structured exercise program, in addition to usual care, whilst participants in the other group will receive usual care alone. The structured exercise program will likely include walking and resistance exercise. Participants will be asked to complete questionnaires regarding their physical well-being and quality of life. Participants will be followed for up to 5 years.
Interventions
The intervention will involve the individual prescription of aerobic and resistance exercise at moderate-intensity, accumulating at least 150 minutes per week (dose). Women will likely walk and undertake resistance exercises using free-weights or therabands, under mostly unsupervised conditions. A study-trained Exercise Professional (ExP) will prescribe and monitor exercise type, duration and frequency on a weekly basis and modify prescription according to presentation of symptoms and by adherin
The intervention will involve the individual prescription of aerobic and resistance exercise at moderate-intensity, accumulating at least 150 minutes per week (dose). Women will likely walk and undertake resistance exercises using free-weights or therabands, under mostly unsupervised conditions. A study-trained Exercise Professional (ExP) will prescribe and monitor exercise type, duration and frequency on a weekly basis and modify prescription according to presentation of symptoms and by adhering to the exercise principle of gradual progression. The exercise program will continue for the duration of chemotherapy or for a maximum of 18 weeks for participants who discontinue chemotherapy early.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women with newly diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer of any histological type, suitable for first-line chemotherapy 2. Age > or = 18 years 3. ECOG status 0-2 4. Willing and able to comply with all study requirements, including the exercise intervention, timing and/or nature of required assessments 5. Sufficiently fluent in English to fully participate in data collection requirements and comprehend intervention requirements 6. Scheduled for chemotherapy or has commenced chemotherapy. Participants must be enrolled prior to commencement of the 2nd cycle of chemotherapy 7. Signed written informed consent
Exclusion criteria
1. Women with diagnosis of recurrent ovarian cancer 2. History of another malignancy within 3 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, Stage I melanoma in situ or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease-free for at least 3 years after definitive primary treatment. 3. Concurrent illness, including severe infection or unstable angina that may jeopardise the ability of the patient to undergo the exercise intervention outlined in this protocol with reasonable safety. 4. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
Outcome results
None listed