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临床试验/CTRI/2025/10/095576
CTRI/2025/10/095576尚未招募不适用

Evaluation of Scalp Cooling for Hair Preservation in Breast and Gynecologic Cancer Patients Receiving Chemotherapy

Tata Memorial Centre1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年10月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
240
试验地点
1
主要终点
Hair Preservation (less than 50 percentage of Hair loss)

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
Female

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Hair Preservation (less than 50 percentage of Hair loss)

时间窗: Baseline and subsequently at week 4, 6 and 12

次要结局

  • Overall Survival (OS)(5 years)
  • Progression-Free Survival (PFS)(2-5 years)
  • Quality of Life using EORTC QLQ-C30(Baseline and Week 12)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Anbarasan Sekar

Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre

研究点 (1)

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