Skip to content

Observational study in Breast cancer patient who are taking Anthracyclin Chemotherapy to observe chemotherapy induced nausea and vomiting

A prospective observational study of Chemotherapy Induced Nausea Vomiting (CINV) in patients receiving Anthracycline based chemotherapy for Breast Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2016/01/006555
Enrollment
300
Registered
2016-01-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: null- Breast Carcinoma

Interventions

Intervention1: Basic Research, Technology Development.: Paired tumor and blood samples from Breast cancer patients will be collected at the time of accrual and first and subsequent progressions. 10,

Sponsors

Tata Memorial Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Breast cancer patients receiving first cycle of Anthracycline (Neo) Adjuvant chemotherapy Newly diagnosed Breast cancer patients requiring anthracycline regimens Patients with histologically confirmed invasive breast carcinoma. ECOG PS 0-2 at study entry Age more than 18 years

Exclusion criteria

Exclusion criteria: Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed Patients who had received or were to receive radiation therapy to the abdomen or pelvis in the week prior to treatment Patients who had vomited in the 24 hr prior to treatment or on concurrent intake of any other emetogenic drug or radiotherapy or a known hypersensitivity to 5-HT3-receptor antagonists or dexamethasone Patients who had an active infection or any uncontrolled disease other than malignancy Baseline laboratory values outside the clinically acceptable limits{Abnormal laboratory values (absolute neutrophil count 2.5× upper limit of normal, alanine transaminase >2.5× upper limit of normal, bilirubin >1.5× upper limit of normal, creatinine >1.5× upper limit of normal}. Asymptomatic metastases to the brain Seizure disorder needing anticonvulsants unless clinically stable Intestinal obstruction

Design outcomes

Primary

MeasureTime frame
To understand the incidence of CINV amongst patients undergoing Anthracycline based or highly emetogenic chemotherapy for breast cancer.Timepoint: To understand the incidence of CINV amongst patients undergoing Anthracycline based or highly emetogenic chemotherapy for breast cancer.

Secondary

MeasureTime frame
To study the impact of co varieties on the incidence of CINV amongst patients undergoing Anthracycline based or highly emetogenic chemotherapy for breast cancer.Timepoint: End of 5th day of chemotherapy

Countries

India

Contacts

Public ContactYogesh Kembhavi

Tata Memorial Hospital

sudeepgupta04@gmail.com02224177201

Outcome results

None listed

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