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

An Exploratory Clinical Study of Statins for Improving Chemotherapy and Maintenance in Patients With Ovarian Cancer: a Prospective, Multicenter Clinical Study

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.

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: Statin; Drug: Sugar pill

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Bai-Rong Xia, Doctor; Phone Number: 18604516165; Email: xiabairong9999@126.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Recruiting
      • Anhui Cancer Hospital
      • Contact: Bai-Rong Xia, MD; Phone Number: 18604516165; Email: xiabairong9999@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Statin Group; Statins, 40 mg daily for 1 year or with dosage adjusted based on patient tolerance	Drug: Statin; Statin Group: Conventional chemotherapy and maintenance therapy combined with statins.
Placebo Comparator: Control Group; Sugar pill daily for 1 year	Drug: Sugar pill; Control Group: Conventional chemotherapy and maintenance therapy alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	The time between the start of the trial and tumor progression (in any way) or death (from any cause)	12-month
Disease free survival	Time from surgical resection to local recurrence	12-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of tumor marker CA125	Changes in Serum CA125 from Enrollment to End of Trial	12-month
Changes of tumor marker HE4	Changes in Serum HE4 from Enrollment to End of Trial	12-month
Lipid change	Changes in Serum Lipid from Enrollment to End of Trial	12-month

Collaborators and Investigators

• Sponsor: Anhui Provincial Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: June 15, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 15, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Statins
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: 2024 NO. 049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No