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Study of Scalp Cooling Therapy to Prevent Hair Loss in Breast Cancer Patients Undergoing Chemotherapy

Efficacy and Safety of Low-Temperature ( 7 C) Scalp Cooling for Prevention of Chemotherapy-Induced Alopecia in Breast Cancer Patients Receiving Anthracycline-Based Chemotherapy: A Prospective, Single-centre pilot feasibility and Safety Study - SCARLET, Breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/112897
Enrollment
40
Registered
2026-06-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Scalp cooling 7 C: Participants will receive standard anthracycline-based chemotherapy as per institutional practice. Low-temperature ( 7 C) scalp cooling using a modified EVA Scalp C

Sponsors

Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Willingness to take part confirmed through written informed consent. 2.Adult patients age greater or equal to 18 years with histologically confirmed breast cancer 3.Adequate performance status ECOG performance status 0 2. 4.Willingness and ability to undergo scalp cooling. 5.Ability to provide informed consent and comply with study requirements

Exclusion criteria

Exclusion criteria: 1.Patient with prior alopecia. 2.Previous exposure to chemotherapy radiotherapy head and neck. 3.Presence of other active malignancies or recent cancer treatment. 4.History of autoimmune diseases or immunodeficiency disorders. 5.Inability to provide informed consent or comply with study procedures.

Design outcomes

Primary

MeasureTime frame
Degree of hair preservation assessed using a standardized alopecia grading scale Dean s scale or equivalent.Timepoint: 1.5 year—

Secondary

MeasureTime frame
1.Incidence of scalp-related adverse events pain cold injury skin changes headaches 2.Patient-reported comfort & tolerability 3.Rate of premature discontinuation of scalp cooling 4.Hair regrowth at 6 weeks & 12 weeks post completion of chemotherapy 5.Operational feasibility & nursing feedback Timepoint: 1.5 year—

Countries

India

Contacts

Public ContactDr Akhil Kapoor

Mahamana Pandit Madanmohan Malviya Cancer Centre (MPMMCC)

drkumarradonc@gmail.com9971824464

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026