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Ovarian CancerPhase 2OC-POP-PTNCT06839144

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

A Phase 2 study testing Propranolol (Beta-Blocker) and Etodolac (COX-2 Inhibitor) in people with Ovarian Cancer and Ovarian Cancer Metastatic Recurrent, run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 85 years, women only
What is being tested?
Propranolol (Beta-Blocker) and Etodolac (COX-2 Inhibitor)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
2 sitesIsrael
Study dates
12 Mar 2025to 31 Aug 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 20-85
  • ASA score 1-3 or ECOG Performance Status of 0 to 2
  • Patients with a suspected high-grade ovarian epithelial cancer based on imaging, clinical examination, CA125, and/or tumor biopsy
  • Patients planned for surgery for primary surgery, or interval debulking surgery for ovarian cancer
  • Signed informed consent form
  • Willing and able to comply with study procedures (physically and mentally)

Who cannot join

  • Patients who participate in another interventional study
  • Patients with known allergy to one or more of the study medications, or to any medication from the non-steroidal anti-inflammatory drug group or beta-blockers family
  • Patients treated chronically with any type of a beta-adrenergic blocker or a COX inhibitor, except use of Aspirin, which will be discontinued at least 7 days prior to surgery, and until 3 weeks post-surgery
  • Patients currently suffering from asthma (אסתמה פעילה בלבד), or required hospital admission or change in medical treatment for asthma within the past year
  • Patients with active peptic disease
  • Patients with a history of CVA/TIA
Show all 21Show fewer
  • Recent (within the last 5 years) or concurrent malignancies, with the exception of adequately treated in-situ carcinoma of the cervix or basal-cell carcinoma of the skin
  • Patients with renal failure, measured by creatinine level >1.5
  • Patients with significant liver dysfunction (known cirrhosis, Bilirubin level>2)
  • Patients with significant heart failure (NYHA functional class 3 or Higher)
  • Patients with bradycardia (heart rate of 50 or less) or second- or third-degree AV block
  • Patients with right-sided heart failure owing to pulmonary hypertension
  • Patients with chronic Digoxin treatment
  • Patients with Printzmetal's angina
  • Patients with significant diagnosed cardiomegaly
  • Patients suffering from sick sinus syndrome
  • Patients with peripheral vascular disease
  • Patients with current (unresected) pheochromocytoma
  • Pregnant women
  • Patients who are treated with immunosuppressive medications, including chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial drug
  • Patients with Immunodeficiency Disorders

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shamgar Ben-Eliyahu, Prof. contact

972-3-6407266

shamgar@tauex.tau.ac.il

Israel2 sites, 2 recruiting

  • The Chaim Sheba Medical Center

    Ramat Gan, 5266202

    Anna Blecher, Dr., 972-52-9280101, anna.blecher@sheba.health.gov.il

    Recruiting

  • Tel Aviv Sourasky Medical Center (Ichilov Hospital)

    Tel Aviv, 6997801

    Nadav Michaan, Prof., 972-52-7360283, nadavm@tlvmc.gov.il

    Recruiting

Other trials in Israel

About this study

Official title: Inhibiting Beta-adrenergic and COX-2 Signaling During the Perioperative Period to Reduce Ovarian Cancer Progression: A Randomized Placebo-Controlled Clinical Trial

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.

Read the detailed description

The study is a placebo-controlled randomized clinical trial (RCT) enrolling 60 women undergoing ovarian cancer debulking surgery. Participants will be assigned to receive propranolol (starting 5 days preoperatively, increased on the day of surgery, and continued postoperatively) and etodolac at a fixed dose. The primary outcomes include recruitment rate, drug safety, tolerability, adherence, and molecular tumor and blood characteristics. Secondary outcomes include 3-year recurrence rates.

Being tested
Propranolol (Beta-Blocker) and Etodolac (COX-2 Inhibitor), Placebo (Matching for Propranolol & Etodolac)
Keywords
Ovarian Cancer, Perioperative Intervention, Beta-Blockers, Propranolol, COX-2 Inhibitors, Etodolac, Psychoneuroimmunology, Stress and Cancer, Randomized Controlled Trial (RCT), Biomarker Analysis
Medical subject headings
Ovarian Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    • 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.

  • Placebo (Matching for Propranolol & Etodolac)Drug

    • Placebo Arm: Placebo (Matching for Propranolol \& Etodolac). Inert placebo tablets matching propranolol and etodolac in appearance and dosing schedule. Administration Route: Oral.
Study groups in NCT06839144
Study groupRoleWhat they receive
Intervention ArmExperimentalPatients receive propranolol + etodolac (active treatment)
Receives: Drug: Propranolol (Beta-Blocker) and Etodolac (COX-2 Inhibitor)
Placebo ArmPlacebo comparatorPatients receive matching placebo for both drugs
Receives: Drug: Placebo (Matching for Propranolol & Etodolac)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Transcriptional Activity in Excised Tumors

    Transcriptional activity related to pro-metastatic (e.g., EMT), pro-growth (STAT and GATA families), and stress and inflammatory signaling (NF-κB/cRel, AP-1, CREB, GR) in excised tumors.

    Measured: At the time of surgery (Day 0). Data will be reported through study completion, an average of 2 years.

  2. Transcriptional Activity in Blood Samples

    Longitudinal analysis of transcriptional activity in peripheral blood, focusing on stress/inflammatory pathways (NF-κB/cRel, AP-1, CREB, GR). Unit of measure: Relative expression levels (fold change).

    Measured: Preoperative baseline (Informed consent day), Day 0 (surgery), postoperative Day 1, Week 3, and Week 11. Data will be reported through study completion, an average of 2 years.

  3. Adverse Event Assessment

    Recording and categorization of adverse events, using a standardized tool (e.g., CTCAE-Common Terminology Criteria for Adverse Events) to assess the severity and type of adverse events. Unit of Measure: Number and severity of adverse events.

    Measured: From 5 days pre-surgery to 3 months post-surgery.

  4. Patient Adherence to Drug Regimen

    Patient adherence will be assessed using pill counts or patient self-reports. Unit of Measure: Percentage of prescribed dosage consumed.

    Measured: From 5 days pre-surgery to 3 months post-surgery.

  5. Recruitment Rate

    Number of participants enrolled in the study within the specified timeframe.

    Measured: Study duration (estimated 2 years).

Secondary outcomes (1)

  1. Three-Year Recurrence Rate

    Assessment of recurrence in patients based on medical records and follow-ups at 3 years post-surgery.

    Measured: 3 years post-surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2025
  2. Study start12 Mar 2025
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06839144
Sponsor's protocol ID
TLV-0199-24
Other IDs
1R21CA291683-01
Acronym
OC-POP-PT
Status last verified
Jul 2025
First submitted
6 Feb 2025
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Shaashua L, Shabat-Simon M, Haldar R, Matzner P, Zmora O, Shabtai M, Sharon E, Allweis T, Barshack I, Hayman L, Arevalo J, Ma J, Horowitz M, Cole S, Ben-Eliyahu S. Perioperative COX-2 and beta-Adrenergic Blockade Improves Metastatic Biomarkers in Breast Cancer Patients in a Phase-II Randomized Trial. Clin Cancer Res. 2017 Aug 15;23(16):4651-4661. doi: 10.1158/1078-0432.CCR-17-0152. Epub 2017 May 10.

    PubMed 28490464

  • Haldar R, Ricon-Becker I, Radin A, Gutman M, Cole SW, Zmora O, Ben-Eliyahu S. Perioperative COX2 and beta-adrenergic blockade improves biomarkers of tumor metastasis, immunity, and inflammation in colorectal cancer: A randomized controlled trial. Cancer. 2020 Sep 1;126(17):3991-4001. doi: 10.1002/cncr.32950. Epub 2020 Jun 13.

    PubMed 32533792

  • Haldar R, Shaashua L, Lavon H, Lyons YA, Zmora O, Sharon E, Birnbaum Y, Allweis T, Sood AK, Barshack I, Cole S, Ben-Eliyahu S. Perioperative inhibition of beta-adrenergic and COX2 signaling in a clinical trial in breast cancer patients improves tumor Ki-67 expression, serum cytokine levels, and PBMCs transcriptome. Brain Behav Immun. 2018 Oct;73:294-309. doi: 10.1016/j.bbi.2018.05.014. Epub 2018 May 22.

    PubMed 29800703

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Propranolol (Beta-Blocker) and Etodolac (COX-2 Inhibitor) in people with Ovarian Cancer and Ovarian Cancer Metastatic Recurrent, run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shamgar Ben-Eliyahu, Prof. (972-3-6407266, shamgar@tauex.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transcriptional Activity in Excised Tumors (time frame: At the time of surgery (Day 0). Data will be reported through study completion, an average of 2 years.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06839144, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.

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