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

NCT07269574 | Not Yet Recruiting

• 1 other identifier: TJH-OVC-PARPi-DIET
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

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

Keywords

Ovarian Cancer; High-Grade Serous Ovarian Cancer; PARP Inhibitor; Maintenance Therapy; Dietary Pattern; Low-Carbohydrate Diet

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS is defined as the duration from the start date of PARP inhibitor (PARPi) maintenance therapy to the date of the first documented disease progression or death from any cause, whichever occurs first. Disease progression is assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for radiologic progression or Gynecologic Cancer InterGroup (GCIG) criteria for CA-125 biochemical progression.

  From the initiation of PARPi maintenance therapy until disease progression or death, assessed up to approximately 60 months (5 years).

Secondary Outcomes (3)

• Overall Survival (OS)

  From the initiation of PARPi maintenance therapy until death, assessed up to approximately 60 months.

• Duration of PARP Inhibitor Maintenance Therapy

  From initiation of PARP inhibitor maintenance therapy to permanent discontinuation or last recorded dose, up to 5 years.

• Rate of Treatment Discontinuation Due to Adverse Events

  From the initiation of PARPi maintenance therapy to treatment discontinuation, assessed up to approximately 60 months.

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: This study includes only women with ovarian, fallopian tube, or primary peritoneal cancer. These cancers arise in female reproductive organs, so only female patients who have been diagnosed with these conditions and received PARP inhibitor maintenance therapy are eligible for this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of women with primary high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who were treated at 14 tertiary hospitals in China. Eligible patients underwent primary or interval debulking surgery followed by first-line platinum-based chemotherapy, achieved complete or partial response, and then received a PARP inhibitor as first-line maintenance therapy between 2020 and 2025. Participants are identified from hospital electronic medical records, and those who can be contacted and are willing to participate will complete a retrospective food frequency questionnaire about their usual diet during PARP inhibitor maintenance.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tongji Hospital: lead
• West China Second University Hospital: collaborator
• Peking University People's Hospital: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Qilu Hospital of Shandong University: collaborator
• Shanghai First Maternity and Infant Hospital: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• Henan Provincial People's Hospital: collaborator
• The First Affiliated Hospital of Henan University of Science and Technology: collaborator
• Women's Hospital of Zhejiang University: collaborator
• Sun Yat-Sen University Cancer Center: collaborator
• Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood samples (approximately 5 mL) will be collected from consenting participants at the main study center (Tongji Hospital). Samples will be processed into serum/plasma and stored at -80°C for at least 5 years. These biospecimens will be used for analyzing nutritional and metabolic indicators (e.g., albumin, lipids) and conducting exploratory omics research (including metabolomics, proteomics, and/or transcriptomics) to investigate the association between metabolic profiles and PARPi maintenance therapy outcomes.

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

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; Fallopian Tube Diseases

Central Study Contacts

Qinglei Gao, PhD.

CONTACT

+86-27-83662681; qingleigao@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 8, 2025
• Study Start: November 27, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11