Pre-habilitation in ovarian cancer cytoreductive surgery and its effect on postoperative morbidity (PROSPERITY): A randomized controlled trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- The primary outcomes are 30 day comprehensive complication index in the two groups. It will be assessed based on a online tool. (https://www.assessurgery.com/about_cci-calculator/ )
Study Overview
Brief Summary
Cancer of the ovaries is the third most common cancer in women. It also has the worst outcomes and high risk of death. This is due to lack of screening method, delayed symptom onset and insidious growth of the disease earning it the moniker of ‘the silent killer’. Cancer ovary is the leading cause of death from cancer in Indian women. Most of the patients are diagnosed in the advanced stages, stages 3 and 4, when only 28% of them have the chance of survival at 5 years.
Treatment of most of the ovarian cancers includes chemotherapy followed by surgery and subsequent cycles of chemotherapy. Chemotherapy though beneficial in reducing the cancer extent, has concomitant side effects which predispose these patients to poor nutrition, anemia, decreased immunity, general debility and muscle wasting. These negatively impact their physical functioning in daily activities and predispose these patients to prolonged hospitalization, need for blood transfusions, post-surgical infections and also increase the health care costs. Post- surgical complications impair their quality of life and also reduce their chance of completion of subsequent cycles of chemotherapy. Consequently, they enter a state of life long dependency and the overall survival of these patients is also adversely affected.
The patient factors adversely affecting their surgical outcome can be mitigated by prehabilitation. Prehabilitation is the process of improving the functional ability of the individual to enable them to ‘weather the storm’ of surgery. Prehabilitation incorporates components of exercise training, nutrition support and mental health counseling in the 2 to 4 weeks period before surgery. Prehabilitated patients are better placed to cope with surgery and avoid or overcome complications. Even if the prehabilitated patients develop a complication, they have the reserve to recover and maintain a life of independence.
The aim of the proposed project is to investigate the feasibility of prehabilitation in patients undergoing surgery for cancer ovary after chemotherapy and to determine its effects on reducing the complications post-surgery as compared to the current standard care.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Age > 18 years
- •Patients awaiting elective cytoreductive surgeries for ovarian cancer after completion of the due course of chemotherapy.
- •3.Time to surgery 2 to 6 weeks.
Exclusion Criteria
- •1.Laparoscopic surgery 2.Heart disease with positive stress test 3.Chronic pulmonary disease with dyspnoea at exertion.
- •4.Limb immobility 5.Hemoglobin <7 g/dl 6.Acute infection 7.Known hypersensitivity to any drugs or to parenteral iron 8.Bronchial asthma 9.Chronic liver disease with SGOT, SGPT >3 times the upper limit of normal 10.Renal disease requiring dialysis 11.Inability to comprehend and perform the exercise interventions 12.Active bleeding from tumour 13.Massive ascites /pleural effusion refractory after the last cycle of chemotherapy 14.Patients for primary surgery will be excluded.(Surgery before chemotherapy).
Outcomes
Primary Outcomes
The primary outcomes are 30 day comprehensive complication index in the two groups. It will be assessed based on a online tool. (https://www.assessurgery.com/about_cci-calculator/ )
Time Frame: The primary outcomes are 30 day comprehensive complication index in the two groups. It will be assessed based on a online tool. (https://www.assessurgery.com/about_cci-calculator/ )
Secondary Outcomes
- To compare, in patients undergoing ovarian cytoreductive surgeries, prehabilitation and conventional care with respect to(1.Six minute walk test- assessed on day before surgery and four weeks after surgery.)