Clinical trial · Interventional
A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)
Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study
NCT05429970CI-TRIAL-00116413recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to see if propranolol and etodolac along with mind-body resilience training/MBRT and music therapy help participants who are experiencing physiological stress before, during, and after primary debulking surgery/PDS or IDS and also if it's better than the standard-of-care approach (no intervention for reducing stress).
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage II Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Ovary Cancer | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Etodolac | Drug | — | UNRESOLVED |
| Mind-body resilience training | Behavioral | — | UNRESOLVED |
| Music therapy | Behavioral | — | UNRESOLVED |
| Propranolol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PSRB
- description
- Participants will receive mind-body resilience training/MBRT, music therapy, propranolol and etodolac pre and post operatively. Postoperative Psychological Interventions may occur between POD 1-7 if needed.
- interventionNames
- Behavioral: Mind-body resilience training
- Behavioral: Music therapy
- Drug: Propranolol
- Drug: Etodolac
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- Participants will receive usual care (study interventions not specifically recommended)
Primary outcomes (1)
- measure
- Number of participants successfully completing over 80% of the bundled interventions
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced (stage II-IV) epithelial ovarian, fallopian tube, or primary peritoneal carcinoma diagnosed on the basis of imaging, CA125, and clinical assessment * Scheduled to undergo exploratory laparotomy and PDS or IDS * Scheduled for surgery with at least 10 days of lead time, to allow the participant to take the β-blocker and COX2 inhibitor 7 days preoperatively * Age ≥18 years * ASA score of 1 to 3 * Ability to understand the study objectives and procedures, comply with the protocol, and provide informed consent Exclusion Criteria: * Chronic treatment with any β-blocker or COX inhibitor * Contraindication for β-blocker therapy (asthma, second- or third-degree atrioventricular block, sinus bradycardia, sick sinus syndrome, right-sided heart failure, pheochromocytoma, peripheral vascular disease) * Contraindication for COX2 inhibitor therapy (renal failure \[creatinine level \>1.5 mg/dL\], significant liver failure \[known cirrhosis, bilirubin level \>2\], active peptic disease), or current use of oral anticoagulant) * Contraindication for regional epidural anesthesia * Chronic autoimmune disease * Active infection * Pregnant * Minimally invasive procedure * Participation in another clinical trial that interferes with this study
References
Publications (0)
Data not yet available
No reference posted for this study.