Inhibiting Beta-adrenergic and COX-2 Signaling During the Perioperative Period to Reduce Ovarian Cancer Progression

NCT06839144 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-11

No results posted yet for this study

Summary

This study investigates the impact of perioperative inhibition of beta-adrenergic and COX-2 signaling in ovarian cancer patients undergoing debulking surgery. The trial aims to assess the feasibility, safety, and biological effects of a combination of propranolol and etodolac in reducing cancer metastasis and improving immune responses.

Conditions

Interventions

DRUG

Propranolol (Beta-Blocker) and Etodolac (COX-2 Inhibitor)

\- Intervention Arm: Propranolol (Beta-Blocker) and Etodolac (COX-2 Inhibitor). Name: Propranolol (slow-Release) and Etodolac. Propranolol Dosage Schedule: 5 days pre-surgery: 20mg twice daily (BID), Day of surgery: 80mg BID, 1-week Post-surgery: 40mg BID, week 2-11 post-surgery: 20mg BID. Etodolac Dosage Schedule: 5 days pre-surgery until 3 weeks post-surgery: 400mg BID. Administration Route: Oral.

DRUG

Placebo (Matching for Propranolol & Etodolac)

\- Placebo Arm: Placebo (Matching for Propranolol \& Etodolac). Inert placebo tablets matching propranolol and etodolac in appearance and dosing schedule. Administration Route: Oral.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • The Chaim Sheba Medical Center

    collaborator OTHER
  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Nadav Michaan, Prof. · Tel Aviv Sourasky Medical Center (Ichilov Hospital)

  • Anna Blecher, Dr. · The Chaim Sheba Medical Center (Tel Hashomer)

  • Shamgar Ben-Eliyahu, Prof. · Tel Aviv University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-12
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06839144 on ClinicalTrials.gov