A Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Nausea of Niraparib in the Maintenance Treatment in Ovarian Cancer

Sponsor
Sichuan Cancer Hospital and Research Institute
Study ID
NCT05641506
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Yangzheng Xiaoji — DRUG
    Chinese patent medicine Yangzheng Xiaoji capsule， 0.36g\*4 tid，28 days as one cycle，up to 3 cycles.
  • Niraparib — DRUG
    Niraparib 200 or 300mg\* QD PO continually; \*The starting dose of niraparib was individualized based on patients' bodyweight and baseline platelet count; 200 mg QD for Patients with baseline body weight \<77 kg or platelets count \<150,000/μL;300 mg QD for Patients with baseline body weight ≥77 kg and platelets count ≥150,000/μL.

Study Details

This study is an open-label, single-Arm， phase II clinical trial of a Chinese Patent Medicine Yangzheng Xiaoji Capsule to improve the adverse reaction nausea of Niraparib in the first-line maintenance treatment in advanced epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

Key Dates

Start date
Dec 31, 2022
Status verified
Nov 2022
Primary completion
Oct 31, 2023
Completion
May 31, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm
    Participants received Niraparib 200mg or 300mg QD PO continually combined with Yangzheng Xiaoji capsule， 0.36g\*4 tid，28 days as one cycle，up to 3 cycles.

Primary Outcome Measure

Incidence of nausea [ Time Frame: 3 cycles (each cycle is 28 days) ]

Central Contacts

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