CTRI/2023/05/053011招募中3 期
A multi-center, investigator-initiated, open label, randomized, parallel-group, superiority trial to investigate the efficacy and safety of scalp cooling system in prevention of chemotherapy induced alopecia inpatients with breast cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- JIPMER
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Early and locally advanced breast cancer planned for adjuvant/ neoadjuvant chemotherapy involving anthracyclines and/ or taxanes. Patients receiving concurrent therapy with trastuzumab in Her2 positive breast cancers will be permitted to be enrolled.
- •Plan to complete chemotherapy within 4-6 months.
- •Both dose dense (every 2 weekly) and conventional (every 3 weeks) chemotherapy will be permitted
- •ECOG PS 0-2
- •Able to give informed consent.
- •Willing to participate in study and agree to have photographs of the head (no facial identification) taken from 5 directions at least 3 times.
- •Patients who choose to wear a wig will be permitted
排除标准
- •Patients with synchronous second cancers or any other malignancy.
- •Patients who have already initiated chemotherapy or have already undergone chemotherapy.
- •Patients who have received chemotherapy in the past for any cancer must have a minimum of 2 years gap from previous chemotherapy and must have fully regrown their hair.
- •Preexisting hair fall, or other hair disorders like alopecia areata, skin conditions like lupus
- •History of brain radiation
- •Uncontrolled or poorly treated hypo or hyperthyroidism
- •History of migraine headaches
- •Patients with any other illness or health condition which in the opinion/medical judgment of the study investigator makes the patient ineligible to participate in the study.
- •Patients who have shaved their heads before starting chemotherapy.
- •No specific interventions for hair regrowth like serum injection etc. will be permitted, or agents like minoxidil will not be permitted.
- •If the head size is not properly fitting the device cap size
- •Pregnant women
研究者
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