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Examining the effect of adding melatonin to chemotherapy in patients with ovarian cancer.

Assessment the effect of adding melatonin to chemotherapy compared to placebo on the rate of relapse or metastasis in ovarian cancer patients undergoing adjuvant chemotherapy.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20110523006563N5
Enrollment
40
Registered
2024-11-10
Start date
2024-12-21
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian cancer. Malignant neoplasm of unspecified ovary

Interventions

Intervention 1: Intervention group: In this group, after surgery, standard chemotherapy with Carboplatin at a dose of 5-6 AUC and Paclitaxel at a dose of 175 mg/m2 will be started for 3 to 6 cycles ev

Sponsors

Vice chancellor for Research, Tabriz University Of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Patients with ovarian cancer who have undergone initial surgery TAH+BSO staging or tumor debulking surgery. Patients whose surgery will be optimal (no mass remains in the abdomen and pelvis, or remaining mass is less than 5 mm) or suboptimal (remaining mass in the abdomen and pelvis is more than 5 mm) and who are candidates for adjuvant chemotherapy. The histological types of tumors include serous grade, mucinous, endometrioid, clear cell, and undifferentiated, as well as malignant Brenner tumors.

Exclusion criteria

Exclusion criteria: Sensitivity to melatonin Previous history of malignancy History of previous chemotherapy and radiotherapy Patients with metastasis to distant tissues such as bones, liver, and kidneys. Patients with a history of neoadjuvant chemotherapy Intolerance to chemotherapy drugs Receiving vitamin E and omega-3 supplements before or during chemotherapy Non-epithelial tumors including germ cell and sex-cord stromal tumors, and metastatic tumors to the ovaries Patients who have undergone fertility-sparing surgery, meaning Stage IA Grade 1 who do not require chemotherapy. Patients with kidney and liver failure, diabetes, and seizures Use of anticoagulant medications History of autoimmune disease and immunosuppressive medications.

Design outcomes

Primary

MeasureTime frame
Relapse of illness. Timepoint: At the end of the third and sixth treatment cycles and six months after finishing chemotherapy. Method of measurement: Measurement of related tumor markers CA125, CEA, and CT scans of the chest, abdomen, and pelvis, both orally and injected.;Death caused by illness. Timepoint: At the end of the third and sixth treatment cycle and 6 months after finishing chemotherapy. Method of measurement: Phone call and follow-up with the patient.;Metastasis. Timepoint: At the end of the third and sixth treatment cycles and six months after finishing chemotherapy. Method of measurement: Measurement of related tumor markers CA125, CEA, and CT scans of the chest, abdomen, and pelvis, both orally and injected.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehri Jaefari Shobeiri

Tabriz University of Medical Sciences

lahroudin@gmail.com+98 41 3553 9160

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026