Impact of Dietary Patterns on Prognosis of Ovarian Cancer Patients During PARPi Maintenance
NCT ID: NCT07269574
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
600 participants
OBSERVATIONAL
2025-11-27
2026-12-31
Brief Summary
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* Is there an association between dietary patterns and patients' Progression-Free Survival (PFS)?
* Is there an association between dietary patterns and Overall Survival (OS)? This is a multicenter, retrospective cohort study. Researchers will review electronic medical records from 14 tertiary hospitals in China to identify women who received first-line PARP inhibitor maintenance for advanced high-grade serous ovarian cancer between 2020 and 2025, and collect information on baseline characteristics, treatments and follow-up outcomes.
Researchers will compare patients with a "low-carbohydrate diet pattern" to those with a "regular/high-carbohydrate diet pattern" to see if there are differences in treatment outcomes and survival.
Participants will:
* Have their clinical, pathological, and treatment data collected from electronic medical records.
* Complete a retrospective Food Frequency Questionnaire (FFQ) via phone or clinic visit to recall their dietary habits during the maintenance treatment period.
* Optionally provide a blood sample for nutrition and metabolic analysis. (For participants at the main study center only) No experimental drugs or specific diets will be given in this study. All anti-cancer treatments are decided by the treating physicians as part of routine clinical care.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Low-Carbohydrate Diet Pattern
Patients with high-grade serous ovarian cancer receiving first-line PARP inhibitor maintenance therapy whose usual dietary carbohydrate intake accounts for a lower proportion of total energy. The primary definition of this group will be patients with a percentage of total energy from carbohydrates below the cohort-specific median, as estimated from the retrospective food frequency questionnaire (FFQ). Alternative cut-offs based on published literature and dietary guidelines will be explored in sensitivity analyses.
No interventions assigned to this group
Regular/High-Carbohydrate Diet Pattern
Patients with high-grade serous ovarian cancer receiving first-line PARP inhibitor maintenance therapy whose usual dietary carbohydrate intake accounts for a regular or higher proportion of total energy. The primary definition of this group will be patients with a percentage of total energy from carbohydrates at or above the cohort-specific median, as estimated from the retrospective food frequency questionnaire (FFQ). Alternative cut-offs based on published literature and dietary guidelines will be explored in sensitivity analyses.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically diagnosed with primary high-grade serous ovarian cancer (HGSOC), fallopian tube cancer, or primary peritoneal cancer.
* Received initial tumor cytoreductive surgery (Primary Debulking Surgery or Interval Debulking Surgery) and first-line platinum-based chemotherapy, achieving Complete Response (CR) or Partial Response (PR).
* Received PARP inhibitors as maintenance therapy for the first time following the completion of first-line treatment.
* Complete clinical data available in the electronic medical records, including baseline characteristics, first-line treatment details, PARPi maintenance therapy information, and prognostic follow-up data.
* The patient (or primary caregiver) has normal communication abilities, voluntarily agrees to participate, and is able to cooperate in completing the retrospective Food Frequency Questionnaire (FFQ).
Exclusion Criteria
* Non-high-grade serous histological subtypes (e.g., ovarian clear cell carcinoma, endometrioid carcinoma, mucinous carcinoma, low-grade serous carcinoma).
* Secondary or metastatic ovarian cancer (malignancy originating from other organs).
* Severe deficiency of key clinical or prognostic information that prevents assessment of the primary endpoint.
* Inability to accurately recall dietary information due to cognitive impairment, mental illness, or other reasons.
* Presence of severe metabolic or digestive system diseases during PARPi maintenance therapy that required specific restricted diets (e.g., insulin-dependent diabetes, dialysis-dependent renal insufficiency, short bowel syndrome, active Crohn's disease).
* Occurrence of significant physiological events during the study period that significantly altered dietary structure (e.g., major gastrointestinal surgery).
18 Years
75 Years
FEMALE
No
Sponsors
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West China Second University Hospital
OTHER
Peking University People's Hospital
OTHER
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
The Affiliated Hospital of Qingdao University
OTHER
Qilu Hospital of Shandong University
OTHER
Shanghai First Maternity and Infant Hospital
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
The First Affiliated Hospital of Soochow University
OTHER
Henan Provincial People's Hospital
OTHER
The First Affiliated Hospital of Henan University of Science and Technology
OTHER
Women's Hospital of Zhejiang University
UNKNOWN
Sun Yat-sen University Cancer Centre
UNKNOWN
Tongji Hospital
OTHER
Responsible Party
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Qinglei Gao
Professor
Central Contacts
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Other Identifiers
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TJH-OVC-PARPi-DIET
Identifier Type: -
Identifier Source: org_study_id
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