Clinical trial · Observational
Impact of Dietary Patterns on Prognosis of Ovarian Cancer Patients During PARPi Maintenance
A Multicenter, Retrospective Clinical Study Evaluating the Effect of Different Dietary Patterns on the Prognosis of Ovarian Cancer Patients During PARPi Maintenance Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this retrospective observational study is to evaluate the relationship between different dietary patterns (specifically low-carbohydrate diets) and the prognosis of patients with high-grade serous ovarian cancer (HGSOC) receiving first-line PARP inhibitor (PARPi) maintenance therapy. The main questions it aims to answer are: * 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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancers | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| High-grade Serous Ovarian Cancer | High-Grade Serous Ovarian Cancer | ONTOLOGY_EXACT | 0.98 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Low-Carbohydrate Diet Pattern
- description
- 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.
- label
- Regular/High-Carbohydrate Diet Pattern
- description
- 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.
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- From the initiation of PARPi maintenance therapy until disease progression or death, assessed up to approximately 60 months (5 years).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged 18 to \<75 years. * 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: * Clinical diagnosis only, without pathological or cytological confirmation. * 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).
References
Publications (0)
Data not yet available