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Understanding nausea and vomiting in breast cancer patients and its causes during chemotherapy

Assessment of Chemotherapy-Induced Nausea and Vomiting Despite Antiemetic Prophylaxis and Associated Contributory Factors in Breast Cancer Patients- A Real World, Prospective, Observational Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/03/106908
Enrollment
90
Registered
2026-03-25
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

Asma A
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with a confirmed breast cancer diagnosis, female adults above 18 years, patients who are able to report nausea and vomiting, patients receiving chemotherapy in real-world clinical setting, patients who agree to participate in prospective follow-up during chemotherapy cycle

Exclusion criteria

Exclusion criteria: Patients with non-breast malignancies or concurrent secondary cancers, patients with pre-existing nausea and vomiting due to causes other than chemotherapy, patient with cognitive, neurological or psychiatric disorder affecting symptom reporting, patients unable to provide informed consent or comply with study follow up, pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is to determine the incidence and severity of chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients despite receiving antiemetic prophylaxis. The occurrence of acute CINV (0-24 hours) and delayed CINV (24-120 hours) following chemotherapy will be assessed. Nausea severity will be measured using the Numeric Rating Scale , and the overall incidence and pattern of nausea and vomiting will be evaluated using the MASCC Antiemesis tool. The severity of nausea and vomiting will be graded using CTCAE v6.0.Timepoint: 6 months—

Secondary

MeasureTime frame
To assess adherence to antiemetic prophylaxis using the Medication Adherence Report Scale (MARS) and evaluate its association with the occurrence and severity of CINV.Timepoint: 6 months—

Countries

India

Contacts

Public ContactDr Manish Kundar

Karavali College of Pharmacy

manishkundar6@gmail.com8105377059

Outcome results

None listed

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