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Pilot randomised double-blind placebo-controlled trials of Wuzhuyu Decoction in relieving chemotherapy-induced nausea and vomiting of breast cancer

Pilot randomised double-blind placebo-controlled trials of Wuzhuyu Decoction in relieving chemotherapy-induced nausea and vomiting of breast cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046302
Enrollment
Unknown
Registered
2021-05-12
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

Sponsors

Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 100 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Vomit score;

Countries

China

Contacts

Public ContactLi Tian

Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine

286121945@qq.com+86 18964729586

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026