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Trial Title:
An Exploratory Clinical Study of Statins for Improving Chemotherapy and Maintenance in Patients With Ovarian Cancer
NCT ID:
NCT06468254
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Conditions: Keywords:
Statins
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Statin
Description:
Statin Group: Conventional chemotherapy and maintenance therapy combined with statins.
Arm group label:
Statin Group
Intervention type:
Drug
Intervention name:
Sugar pill
Description:
Control Group: Conventional chemotherapy and maintenance therapy alone.
Arm group label:
Control Group
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Cancer Hospital
Address:
City:
Hefei
Zip:
230001
Country:
China
Status:
Recruiting
Contact:
Last name:
Bai-Rong Xia, MD
Phone:
18604516165
Email:
xiabairong9999@126.com
Start date:
June 30, 2024
Completion date:
March 30, 2026
Lead sponsor:
Agency:
Anhui Provincial Cancer Hospital
Agency class:
Other
Source:
Anhui Provincial Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06468254
