Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Health Condition 2: C399- Malignant neoplasm of lower respiratory tract, part unspecified Health Condition 3: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Physicianâ??s choice systemic therapy.: Systemic chemotherapy will be administered at the physicians discretion. The chemotherapy regimen is not protocol specific and hence details cann
Sponsors
Cancer Research and Statistics Foundatiion
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects must be planned for either taxane-based or anthracycline-based chemotherapy regimens. 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3. 3. Subjects must have normal organ and marrow function. 4. Willing and able to comply with all study requirements, including treatment, able to be follow-up at regular intervals, and/or nature of required assessments. 5. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1. Subjects who have preexisting alopecia. 2. Within 3 weeks of administration of a chemotherapeutic agent. 3. An active autoimmune disease that may contribute to the development of alopecia when receiving a chemotherapeutic agent. 4. Pregnant and lactating women are excluded from this study. 5. Local site infection making it infeasible for use of a scalp cooling device. 6. Subjects with cold agglutinin disease or cryoglobulinemia or post-traumatic cold dystrophy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rate of grade 2 alopecia between the 2 armsTimepoint: Baseline, after 4 cycles of chemotherapy, and at the completion of chemotherapy if the participant received more than 4 cycles of chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| a. To compare the QoL between the 2 arms b. To study the local adverse event in the scalp cooling deviceTimepoint: a. Baseline, after 4 cycles of chemotherapy, and at the completion of chemotherapy if the participant received more than 4 cycles of chemotherapy. b. From the first session up to 2 days after the last session | — |
Countries
India
Contacts
Public ContactDr Ashay Karpe
Cancer Research and Statistics Foundation
Outcome results
None listed