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

NCT06468254 | Recruiting Phase 2

• 1 other identifier: 2024 NO. 049
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Keywords

Statins

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Changes of tumor marker CA125

  12-month

• Changes of tumor marker HE4

  12-month

• Lipid change

  12-month

Study Arms (2)

Statin Group

EXPERIMENTAL

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

Drug: Statin

Control Group

PLACEBO COMPARATOR

Sugar pill daily for 1 year

Drug: Sugar pill

Interventions

Statin DRUG

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

Statin Group

Sugar pill DRUG

Control Group: Conventional chemotherapy and maintenance therapy alone.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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:
• Active viral infections such as HIV, hepatitis B, or hepatitis C.
• Severe cardiovascular diseases, including uncontrolled ventricular arrhythmias or a recent (within the last 3 months) myocardial infarction.
• Uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorders affecting the ability to provide informed consent.
• 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.

Sponsors & Collaborators

• Anhui Provincial Cancer Hospital: lead

Study Sites (1)

Anhui Cancer Hospital

Hefei, Anhui, 230001, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Sugars

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Carbohydrates

Central Study Contacts

Bai-Rong Xia, Doctor

CONTACT

18604516165; xiabairong9999@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Department of Gynaecology Surgery

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 21, 2024
• Study Start: June 30, 2024
• Primary Completion: May 30, 2025
• Study Completion: March 30, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)