Impact of Dietary Patterns on Prognosis of Ovarian Cancer Patients During PARPi Maintenance

Tongji Hospital

Status: Not yet enrolling

Conditions: Fallopian Tube Cancers; Primary Peritoneal Carcinoma; Ovarian Cancer; High-grade Serous Ovarian Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT07269574

TJH-OVC-PARPi-DIET

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

600 participants in 2 patient groups

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.

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.