Clinical Trials Logo

Clinical Trial Summary

The treatment of choice in advanced ovarian cancer is a cytoreductive surgery combined with chemotherapeutic treatment. This complex and aggressive surgery is associated with high postoperative complication rates that may result in a strong negative impact on the clinical results due to the delay with the start of adjuvant chemotherapy as well as the costs from the surgical process. Multimodal prehabilitation has emerged as an innovative intervention that focuses on optimizing physiological and psychological resilience to withstand the upcoming stress of surgery. It has been shown to reduce postoperative complications in major abdominal surgery, but has not been assessed yet in abdominal onco-gynecological surgery.


Clinical Trial Description

Main objective: To determine the efficacy of multimodal prehabilitation in decreasing postoperative complications in patients undergoing gynecological cancer surgery of high complexity by laparotomy (primary cytoreductive surgery, interval surgery and secondary cytoreductive surgery in advanced ovarian cancer). Design: Multicenter randomized controlled clinical trial. Subjects: 146 patients: 73 in the intervention group and 73 in the control group. Intervention group: PreHAB intervention consists on: 1. High-intensity endurance exercise training program and physical activity promotion remotely controlled with ICT (information and communications technologies). 2. Nutritional counselling to achieve protein intake of 1.5-1.8 g/kg and whey protein supplements. 3. Psychological coping. Control group will receive standard preoperative care. Both groups will receive perioperative care in accordance with the enhanced recovery after surgery (ERAS) guidelines. Measures: Aerobic capacity (incremental stress test), physical activity, operative complications and hospital length and associated costs. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04862325
Study type Interventional
Source Hospital Clinic of Barcelona
Contact Berta Diaz-Feijoo, MD PHD
Phone 932275400
Email bdiazfe@clinic.cat
Status Recruiting
Phase N/A
Start date January 1, 2021
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Not yet recruiting NCT03611179 - Upfront Treatment With Chemotherapy and Bevacizumab in Advanced Ovarian Cancer Phase 2
Not yet recruiting NCT06055348 - SC0191 Plus Chemotherapy in Advanced Ovarian Canceradvanced Ovarian Cancer Phase 1/Phase 2
Completed NCT04135521 - Dose-dense Chemotherapy Versus Intraperitoneal Chemotherapy as First-line Chemotherapy in Advanced Ovarian Cancer
Completed NCT01462149 - Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer Phase 2
Terminated NCT03292172 - A Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of RO6870810 and Atezolizumab (PD-L1 Antibody) in Participants With Advanced Ovarian Cancer or Triple Negative Breast Cancer Phase 1
Not yet recruiting NCT05794659 - Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer Phase 2
Completed NCT04360629 - Efficacy and Safety of Tranexamic Acid in Cytoreductive Surgery for Ovarian Cancer N/A
Completed NCT00516724 - Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel Phase 1
Completed NCT03158935 - The ACTIVATE (Adoptive Cell Therapy InVigorated to Augment Tumor Eradication) Trial Phase 1
Completed NCT05775549 - A Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy in Newly Diagnosed BRCAwt Ovarian Cancer
Active, not recruiting NCT03737643 - Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients Phase 3
Completed NCT01290471 - Study to Assess the Safety and Tolerability of U3-1565 in Subjects With Advanced Solid Malignant Tumors Phase 1
Completed NCT01989546 - Pilot Trial of BMN 673, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Deleterious BRCA Mutations Phase 1/Phase 2
Recruiting NCT04556539 - Study of SC10914 in Patients With gBRCA1/2 Mutation Advanced Ovarian Cancer Phase 2
Completed NCT03161132 - Resistant Ovarian Cancer, Olaparib and Liposomal Doxorubicin Phase 2
Active, not recruiting NCT04065009 - The IPLA-OVCA Trial, Intra-Peritoneal Local Anaesthetics in Ovarian Cancer Phase 3
Active, not recruiting NCT01844986 - Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. Phase 3
Not yet recruiting NCT05924776 - Plasmodium Immunotherapy for Advanced Ovarian Cancer Phase 2/Phase 3
Active, not recruiting NCT03878849 - Investigation of 2X-121 in Patients With Advanced Ovarian Cancer Selected by the 2X-121 DRP® Phase 2