The efficacy of the traditional Chinese medicine formulation Wuzhuyu decoction for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial

Phase 1

Recruiting

• Conditions: breast cancer

• Registration Number: ITMCTR2100004838
• Lead Sponsor: Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients signed informed consent and voluntarily joined the study;
2. Breast cancer was confirmed by pathology or Histocytology;
3. Excluding chemotherapy contraindications, breast cancer patients who plan to receive intravenous chemotherapy drugs;
4. At any time during the current chemotherapy regimen, although there were antiemetic drugs consistent with the guidelines, there was significant CINV. The specific criteria were: nausea and vomiting or the need for more than one supplementary antiemetic drug, and / or >= moderate nausea on the 5-level scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe);
5. The patient's ECoG status was 0, 1 or 2;
6. The researchers determined that the patient could be treated with Wuzhuyu decoction;
7. Aged >=18 years;
8. Life expectancy greater than or equal to 4 months;
9. Willing and able to comply with all research requirements, including treatment, time and nature of assessment required, including diary, quality of life, urine test and any statutory blood test.

Exclusion Criteria

1. Allergic to traditional Chinese Medicine;
2. The researcher judged other conditions not suitable for inclusion in the study;
3. Symptomatic primary or secondary central nervous system malignancies;
4. Symptomatic gastrointestinal obstruction;
5. Disease related nausea or vomiting, need daily antiemetic treatment;
6. History of epilepsy or recurrent seizures;
7. Schizophrenia, other psychosis, severe personality disorder, except depression associated with underlying illness;
8. Patients who are pregnant, breast-feeding or lack of contraception. Women with fertility must have a negative pregnancy test 7 days before registration;
9. Patients who participated in other clinical trials in recent 3 months.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vomit score;