Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Health Condition 2: C579- Malignant neoplasm of female genital organ, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinically confirmed non-metastatic breast or gynecological malignancies for curative intent. 2. Planned for anthracycline-based chemotherapy or non-anthracycline-based chemotherapy. 3. Patients taking scalp cooling.
Exclusion criteria
Exclusion criteria: 1. Women with Common Terminology Criteria for Adverse Events version 5 .0 at baseline. 2. Alopecia grade higher than 0 at baseline. 3. History of prior chemotherapy. 4. Personal history of migraines, cluster or tension headaches, cold agglutinin disease or cold urticaria and lichen planus or lupus. 5. Concurrent active malignancies. 6. Received or will receive radiation therapy to skull.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hair Preservation (less than 50 percentage of Hair loss)Timepoint: Baseline and subsequently at week 4, 6 and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS)Timepoint: 5 years;Progression-Free Survival (PFS)Timepoint: 2-5 years;Quality of Life using EORTC QLQ-C30Timepoint: Baseline and Week 12 | — |
Countries
India
Contacts
Public ContactHeena Shaikh
Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre
Outcome results
None listed