Evaluation of Scalp Cooling for Hair Preservation in Breast and Gynecologic Cancer Patients Receiving Chemotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Tata Memorial Centre
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Hair Preservation (less than 50 percentage of Hair loss)
Study Overview
Brief Summary
Hair loss from chemotherapy is one of the most distressing side effects faced by cancer patients, especially women. While many side effects of chemotherapy can be managed with medication, hair loss is often overlooked—even though it can significantly affect a person’s self-image, emotional well-being, and confidence. Research shows that nearly half of women undergoing chemotherapy consider hair loss the most upsetting side effect, and some even consider refusing treatment because of it.
Scalp cooling is a technique designed to reduce hair loss during chemotherapy. It works by lowering the scalp temperature using a specially designed cooling cap, which decreases blood flow and metabolic activity in the hair follicles. This helps limit the amount of chemotherapy drugs that reach the hair roots, reducing the risk of hair loss. The cooling is applied before, during, and after chemotherapy sessions.
This study will assess how effective and acceptable scalp cooling is among Indian women receiving chemotherapy for breast and gynaecologic cancers. It will measure the extent of hair preservation, document patient experiences, and monitor for any side effects. Although scalp cooling is already available at our centre, results from this study may encourage more hospitals and cancer centres across India to adopt this approach. Widening access to scalp cooling could improve the quality of life and emotional well-being of many more patients undergoing chemotherapy.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Clinically confirmed non-metastatic breast or gynecological malignancies for curative intent.
- •Planned for anthracycline-based chemotherapy or non-anthracycline-based chemotherapy.
- •Patients taking scalp cooling.
Exclusion Criteria
- •Women with Common Terminology Criteria for Adverse Events version 5 .0 at baseline.
- •Alopecia grade higher than 0 at baseline.
- •History of prior chemotherapy.
- •Personal history of migraines, cluster or tension headaches, cold agglutinin disease or cold urticaria and lichen planus or lupus.
- •Concurrent active malignancies.
- •Received or will receive radiation therapy to skull.
Outcomes
Primary Outcomes
Hair Preservation (less than 50 percentage of Hair loss)
Time Frame: Baseline and subsequently at week 4, 6 and 12
Secondary Outcomes
- Overall Survival (OS)(5 years)
- Progression-Free Survival (PFS)(2-5 years)
- Quality of Life using EORTC QLQ-C30(Baseline and Week 12)
Investigators
Anbarasan Sekar
Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre