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
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- hair preservation (HP) rate
研究概览
简要总结
This is a study where patients with breast cancer who are planning to start chemotherapy will be randomly allocated to 2 groups in 2 :1 ratio. Patients in group 1 will undergo scalp cooling using a special device during the infusion of chemotherapy. Patients in group 2 will receive chemotherapy without scalp cooling. We will be assessing the patients at the end of chemotherapy to see whether scalp cooling reduced hair fall caused by chemotherapy. We will also be checking for side effects of the device and looking at hair regrowth after 3 months of completion of the treatment. Scalp cooling will be done during each session of chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
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.
- •If the head size is not properly fitting the device cap size Pregnant women.
结局指标
主要结局
hair preservation (HP) rate
时间窗: at the end of planned adjuvant/neoadjuvant chemotherapy
次要结局
- adverse events due to coooling devce(during the study after each cycle and at end of the study)
- hair regrowth(3 months after completion of chemotherapy)
- change in quality of life using the Breast Cancer-Specific Quality of Life Questionnaire (EORTC BR 23)(after 4 cycles of chemotherapy)
研究者
研究点 (6)
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