A study to see if scalp cooling treatment will be effective in patients receiving chemotherapy.
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: C399- Malignant neoplasm of lower respiratory tract, part unspecifiedHealth Condition 3: C569- Malignant neoplasm of unspecifiedovary
- Registration Number
- CTRI/2023/01/049182
- Lead Sponsor
- Cancer Research and Statistics Foundatiion
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method a. To compare the QoL between the 2 arms <br/ ><br>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. <br/ ><br>b. From the first session up to 2 days after the last session