Skip to content

Comparing Different Anti-emetic regimens for prevention of chemotherapy induced nausea and vomiting in newly diagnosed Breast Cancer

Comparison of Dexamethasone sparing regimens with NEPA (Neupitant/Palonosetron) versus Dexamethasone containing antiemetic therapy for prevention of chemotherapy induced nausea and vomiting in Breast Cancer patients receiving Anthracycline and Cyclophosphamide chemotherapy. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/06/089035
Enrollment
156
Registered
2025-06-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: C50- Malignant neoplasm of breast

Interventions

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Dr Tarun Tomar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed with breast cancer and receiving Anthracycline and cyclophosphamide-based highly emetogenic chemotherapy Adequate Organ function -serum creatinine less than 2.0 mg/dL; serum bilirubin less than 2.0 mg/dL; serum glutamic-oxaloacetic transaminase or serum glutamic-pyruvic transaminase less than or equal to three or more times the upper limits of normal; absolute neutrophil count greater than 1,500 mm3b)

Exclusion criteria

Exclusion criteria: Patients with nausea in the 24 hours before beginning chemotherapy; Concurrent radiation therapy; Patients suffering from tumors with brain metastasis/ or with serious psychiatric conditions; Acutely ill patients such with serious liver and renal disorders and serious cardiac disorders with left ventricular ejection fraction less than 50%; Pregnant and lactating women; Unable or refused to cooperate in the evaluation form of nausea and vomiting.

Design outcomes

Primary

MeasureTime frame
Rating of nausea and vomiting will be by using MAT tool and CTCAE version 5.0 The proportion of patients achieving Overall complete response, Complete response during acute phase, Complete response during delayed phase, Overall complete protection, and No nauseaTimepoint: At baseline and 2 weeks

Secondary

MeasureTime frame
not applicableTimepoint: not applicable

Countries

India

Contacts

Public ContactDr Tarun Tomar

Kasturba Medical College and Hospital

tarun.kmcmpl2022@learner.manipal.edu9720062225

Outcome results

None listed

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