An Exploratory Clinical Study of Statins for Improving Chemotherapy and Maintenance in Patients With Ovarian Cancer

NCT ID: NCT06468254

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2026-03-30

Brief Summary

This study aims to evaluate the effect of statins combined with conventional chemotherapy and maintenance therapy on the prognosis of ovarian cancer patients, exploring its potential to improve survival rates and quality of life.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Statin Group

Statins, 40 mg daily for 1 year or with dosage adjusted based on patient tolerance

Group Type: EXPERIMENTAL

Statin

Intervention Type: DRUG

Statin Group: Conventional chemotherapy and maintenance therapy combined with statins.

Control Group

Sugar pill daily for 1 year

Group Type: PLACEBO_COMPARATOR

Sugar pill

Intervention Type: DRUG

Control Group: Conventional chemotherapy and maintenance therapy alone.

Interventions

Statin

Statin Group: Conventional chemotherapy and maintenance therapy combined with statins.

Intervention Type: DRUG

Sugar pill

Control Group: Conventional chemotherapy and maintenance therapy alone.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants must provide written informed consent before any trial procedures commence. The consent form must be documented and retained at the research center.
• Female patients aged 18 years and older.
• Patients diagnosed with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (collectively referred to as ovarian cancer) through open surgery, laparoscopic surgery, or core needle biopsy confirmed by pathology.
• Patients who will require neoadjuvant chemotherapy followed by direct surgery, or direct surgical chemotherapy.
• Liver Function:

1. Total bilirubin ≤1.5 times the upper limit of normal (ULN) or direct bilirubin ≤1.0 times ULN;

2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times ULN. In cases of liver metastases, AST and ALT must be ≤5 times ULN.

• Kidney Function: Serum creatinine ≤1.5 times ULN, or creatinine clearance rate ≥60 mL/min (calculated using the Cockcroft-Gault formula).
• Participants must be able to understand the trial procedures and be capable of adhering to the trial protocol for the duration of the study. This includes the ability to complete any required treatments, examinations, tests, follow-up appointments, and questionnaires associated with the trial.

Exclusion Criteria

• Are using other investigational drugs or participating in other clinical drug trials simultaneously;
• Have used or are currently using any medications that interact with statins;
• Have active cirrhosis, uncontrolled concurrent diseases, a history of chronic myopathy, active hepatitis, or unexplained persistent elevation of serum aminotransferases;
• Are known to be allergic to statins, or any active or inactive components of drugs with similar chemical structures;
• Are unable to swallow oral medications or have any gastrointestinal disorders that might interfere with the absorption and metabolism of the study drugs, such as uncontrolled nausea and vomiting, gastrointestinal obstruction, or malabsorption;
• Require treatment for symptomatic or uncontrolled brain metastases, including but not limited to surgery, radiation, and/or corticosteroids, or have clinical signs of spinal cord compression;
• Have severe, uncontrolled diseases or conditions that, in the investigator's judgment, make the participant unsuitable for the study. These include but are not limited to:

1. Active viral infections such as HIV, hepatitis B, or hepatitis C.

2. Severe cardiovascular diseases, including uncontrolled ventricular arrhythmias or a recent (within the last 3 months) myocardial infarction.

3. Uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorders affecting the ability to provide informed consent.

4. Uncontrolled hypertension not managed by medication. Immune deficiencies (excluding splenectomy) or other conditions deemed by the investigator to pose a high risk of toxicity.

• Have any medical history or existing clinical evidence indicating the potential to confound study results, interfere with adherence to the trial protocol throughout the study, or not align with the patient's best interests;
• Have a history of or current evidence of other malignancies;
• Are pregnant, breastfeeding, or planning to become pregnant during the study period.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Anhui Provincial Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bai-Rong Xia

Chairman of Department of Gynaecology Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anhui Cancer Hospital

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bai-Rong Xia, Doctor

Role: CONTACT

xiabairong9999@126.com

18604516165

Facility Contacts

Bai-Rong Xia, MD

Role: primary

xiabairong9999@126.com

18604516165

Other Identifiers

2024 NO. 049

Identifier Type: -

Identifier Source: org_study_id