To study if it is safe to avoid drugs that prevent fall in neutrophil counts in blood during paclitaxel chemotherapy.
- Conditions
- Health Condition 1: C50- Malignant neoplasm of breast
- Registration Number
- CTRI/2022/03/041308
- Lead Sponsor
- Indian Association of Supportive Care
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Women/men with stage I-III breast cancer
1. Age group between 18-65 years
2. Eastern Cooperative Oncology Group performance status of 0-1
3. Absolute neutrophil count (ANC) > 1,500/ mL, haemoglobin > 9.0 g/dL, platelets
>100,000/mL
4. Normal hepatic and renal function
1. Patients who had febrile neutropenia during AC chemotherapy. Febrile neutropenia is
defined as a single oral temperature measurement of >101°F or a temperature of >=100.4°F
(>=38.0°C) sustained over 1 hour, with an absolute neutrophil count (ANC) of <500
cells/microliter, or an ANC that is expected to decrease to <500 cells/microliter over the
next 48 hours.
2. Recipient of prior cytotoxic chemotherapy (e.g. in case of metachronous breast cancer)
3. Patients with HIV, hepatitis B or C infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Completion rate of paclitaxel by omitting prophylactic peg GCSFTimepoint: Post 4 cycles of chemotherapy
- Secondary Outcome Measures
Name Time Method 1.Actual usage of peg GCSF ( percentage of patients who will require GCSF) <br/ ><br>2.Hematological toxicities (Neutropenia, FN) <br/ ><br>3.Non-hematological toxicities <br/ ><br>4.Patient Reported Outcomes â?? to be assessed every cycle <br/ ><br>5.Quality of life â?? to be assessed at cycle 1 and at cycle 4 of paclitaxel <br/ ><br>6.Decrease in bone pains <br/ ><br>7.Reduction in cost of treatment <br/ ><br>8.Reduction in hospital visits <br/ ><br>Timepoint: Post 4 cycles of chemotherapy