Efficacy of Rikkunshito on Chemotherapy-Induced Nausea and Vomiting

JRCT ID: jRCT1011190007

Registered date:02/12/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: uterine cervical or corpus cancer
• Date of first enrollment: 23/01/2020
• Target sample size: 180
• Study type: Interventional
• Intervention(s): Patients will be randomly assigned to the rikkunshito group or the placebo group. All patients will receive chemotherapy with intravenous (IV) cisplatin >= 50 mg/m2.

Outcome(s)

• Primary Outcome: CR(no vomiting and no rescue therapy) rate during the delayed phase(24-120 h after cisplatin treatment).

Secondary Outcome

1) CC(CR with no more than mild nausea (NRS<= 3)) rate during the delayed phase
2) TC(CR with no nausea) rate during the delayed phase
3) CR,CC,TC rate during the overall phase (0-120 h after cisplatin treatment)
4) CR,CC,TC rate during the acute phase (0-24 h after cisplatin treatment)
5) Time to treatment failure (i.e., time to the first emetic episode or time to rescue medication) during the overall phase
6) NRS of nausea and appetite during the overall phase
7) Adherence to intervention

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1) Patients with histologically diagnosed uterine cervical or corpus cancer
2) Patients who voluntarily sign the Certified Review Board-approved written informed consent
3) Patients who noticed as cervical or corpus cancer by their doctor
4) Patients who expected to live more than 3months
5) Patients aged >= 20 years at time of enrolment.
6) Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0-2
7) Patients planned to receive chemotherapy including >= 50 mg/m2 of cisplatin as first-line chemotheray
8) Patients who can take drugs and food orally
9) Patients with the following laboratory tests:
1.White blood cell count >= 3000/microL and <= 12000/microL.
2.Neutrophil count >= 1500/microL.
3.Platelet count >= 100,000/microL.
4.Hemoglobin >= 8.0 g/dL.
5.Aspartate aminotransferase <= 100 IU/L.
6.Alanine aminotransferase <= 100 IU/L.
7.Total bilirubin <= 2.0 mg/dL.
8.Potassium >= 3.0 mEq/L
9.Creatinine clearance >= 60 mL/min.
10.No abnormality in electrocardiography (ECG).

Exclude criteria

1) Patients with brain metastasis .
2) Patients with double cancer.
3) Patients with treatment-required seizure.
4) Patients with unconsciousness.
5) Patients with gastrointestinal obstruction.
6) Patients with peritoneal dissemination.
7) Patients with vomiting, or nausea greater than grade 2 as described by the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
8) Patients who are registered to a clinical trial using another medicine.
9) Patients with uncontrollable hypertension.
10) Patients with uncontrollable diabetes mellitus or treated with insulin.
11) Patients treated with corticosteroids, androgen, progestin, traditional Chinese medicine and other drugs with an appetite enhancing effect within one month
12) Patients treated with opioids.
13) Pregnant or breast-feeding women, or those who cannot use contraceptives.
14) Patients with any uncontrollable infectious disease.
15) Patients with body temperature >= 38 degrees.
16) Patients with psychosis.
17) Patients who are alcoholic.
18) Patients who are planned to receive radiotherapy.

Related Information

• Primary Sponsor: Watari Hidemichi
• Source(s) of Monetary Support: AMED