A Phase III randomised, controlled trial of exercise during chemotherapy for patients commencing first line treatment for ovarian cancer
- Conditions
- Ovarian CancerCancer - Ovarian and primary peritoneal
- Registration Number
- ACTRN12614001311640
- Lead Sponsor
- niversity of Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- 524
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Physical well-being<br>Physical wellbeing will be measured using a validated 7 item (score 0-28) subscale of the FACT-O (Functional Assessment of Cancer Therapy-Ovarian) QoL questionnaire [Baseline (pre-intervention) and at 6- and 12-months post-randomisation.];Progression Free Survival (PFS). <br>Information relating to PFS will be extracted from medical records at pre-determined timepoints (3-6 weeks post-chemotherapy, 6- and 12-months post-randomisation, and in the final years of the study).[ 3-6 weeks post-chemotherapy, 6- and 12-months post-randomisation, and in the final years of the study.]
- Secondary Outcome Measures
Name Time Method