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Stress Reduction Intervention versus Standard of Care in Patients with Stage II-III Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Undergoing Surgery, The PRESERVE Study
Trial Status: active
This clinical trial tests the effectiveness of a combination intervention consisting of drugs (propranolol, etodolac, and propofol) and mind-body resilience training (MBRT) and music therapy when compared to standard of care in reducing stress among patients with stage II-III ovarian, fallopian tube, or primary peritoneal cancer undergoing surgery. Propranolol is a type of beta blocker that may help lower rates of metastasis (cancer spread). Etodolac is a COX2 inhibitor and may work the same way as propranolol. Total intravenous anesthesia (TIVA) is a type of anesthesia regimen using propofol as the main anesthetic drug. TIVA with propofol can reduce inflammation, which is a protective reaction to injury, including the “injury” of surgery. MBRT, a meditation technique used to achieve relaxation, may decrease anxiety, stress, pain, and nausea in patients being treated for cancer. Music therapy may produce a calming and relaxing effect. Giving a combination of therapies may help to manage and reduce the effects of stress around the time of surgery in patients with ovarian, fallopian tube, or primary peritoneal cancer.
Inclusion Criteria
Advanced (stage II-IV) epithelial ovarian, fallopian tube, or primary peritoneal carcinoma diagnosed on the basis of imaging, CA125, or 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 beta-blocker and COX2 inhibitor 7 days preoperatively
Age >= 18 years
American Society of Anesthesiology (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 beta-blocker or COX inhibitor
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
Additional locations may be listed on ClinicalTrials.gov for NCT05429970.
I. To investigate the feasibility of implementing a multimodal perioperative multimodality stress-reduction bundle (PSRB) in women undergoing primary debulking surgery (PDS) or interval debulking surgery (IDS) for advanced epithelial ovarian cancer (EOC).
SECONDARY OBJECTIVE:
I. To assess the safety of the PSRB, determined as the incidence of major complications (Memorial Sloan Kettering Cancer Center’s Surgical Secondary Events [SSE] grade >= 3) during the perioperative period (date of randomization until postoperative day [POD] 30).
II. To assess the impact of the PSRB on intraindividual change in additional serum markers of physiologic stress, including inflammatory cytokines and soluble factors (i.e., cortisol, vascular endothelial growth factor [VEGF], tumor necrosis factor (TNF) alpha, TNF-related apoptosis-inducing ligand [TRAIL], IL-6, IL-18, IL-8, and IL-10) from pre-intervention through the postoperative period.
III. To assess the impact of the PSRB on psychosocial stress, determined by the use of four validated questionnaires:
IIIa. Hospital Anxiety and Depression Scale (HADS);
IIIb. Impact of Event Scale (IES);
IIIc. Perceived Stress Scale (PSS);
IIId. Functional Assessment of Chronic Illness Therapy–Spiritual Well-Being (FACIT-Sp-12).
IV. To assess the impact of the PRSB on short-term clinical outcomes:
IVa. Intraoperative and postoperative use of narcotics and analgesics, measured as the amount of morphine milligram equivalents;
IVb. Length of hospital stay;
IVc. Return to bowel function, measured as the time to flatus;
IVd. Time from surgery to first dose of adjuvant chemotherapy.
V. To assess the impact of the PSRB on changes in oncogenic and immune-signaling pathways in tumors and peripheral blood using immunohistochemical (IHC) staining and gene-expression profiling.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP 1:
PRIOR TO SURGERY: Patients undergo MBRT and music therapy over 75 minutes for 7 days, and receive propranolol and etodolac orally (PO) twice daily (BID) for 7 days in the absence of unacceptable toxicity. Patients also undergo collection of blood and tissue samples throughout the trial.
DAY OF SURGERY: Patients receive propofol intravenously (IV) during surgery.
AFTER SURGERY: Patients undergo MBRT and music therapy over 60 minutes on days 3, 4, and 5. Patients also continue receiving propranolol PO BID for 16 days and etodolac PO BID for 14 days in the absence of unacceptable toxicity.
GROUP 2: Patients receive standard of care therapy before and after surgery. Patients also undergo collection of blood and tissue samples throughout the trial.
After completion of study intervention, patients are followed up for 30 days after discharge.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationMemorial Sloan Kettering Cancer Center
