PTH (7-34) for Chemotherapy alopecia in Breast Cancer

PTH (7-34) 用于治疗乳腺癌化疗脱发

• 批准号: 7055435
• 负责人: MICHAEL F. HOLICK
• 金额: $ 25.43万
• 依托单位: IGI, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-06 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7055435
• 关键词: alopecia; breast neoplasms; chemotherapy; clinical research; cyclophosphamide; hair; human; skin

DESCRIPTION (provided by applicant): This Phase I application is an extension of our ongoing program to evaluate the safety and therapeutic potential of parathyroid hormone (7-34) for stimulating and maintaining hair growth. The first part of the project includes the recruitment of 12 normal subjects. 6 subjects will apply topical application of PTH (7-34) that is formulated in Novasome A cream 50 microg/gm for 1 week. 6 control subjects will apply Novasome A cream without the drug daily for one week. If there are no untoward adverse effects, the pTH (7-34) dose will be increased to 100 microg/gm for 2 weeks. The 6 control subjects will continue treatment with Novasome A cream for an additional 2 weeks. Subjects will return for an additional follow-up visit 1 week after the last dose for clinical assessment. Safety evaluations will include clinical observations, laboratory results, and spontaneous adverse event reporting. It is expected that no untoward side effects will be detected and the project will continue on to the next phase. The goal of the second part of this project is to determine whether the topical application of PTH (7-34) is effective for decreasing or preventing chemotherapy-induced alopecia in breast cancer patients. Alopecia is often singled out as the most distressing side effect of chemotherapy. More than 80% of the patients who receive chemotherapy for breast cancer consider alopecia to be the most burdensome aspect of the treatment, and some patients refuse chemotherapy to avoid this side effect. Patients who are diagnosed with stage I-IV breast cancer and scheduled to receive chemotherapy will be recruited. They will be randomized to receive 1 week before and for 9 weeks after initiating their chemotherapy, a once a day topical application of PTH (7-34) that is formulated in Novasome A cream or Novasome A cream without the drug. The scalp will be evaluated for any untoward side effects and blood and urine will be collected to monitor any alteration in calcium metabolism, Alopecia will be documented by digital photography, and by clinical assessment. The results from this study should provide important information as to whether PTH (7-34) can be developed into an effective new approach for preventing or mitigating chemotherapy-induced alopecia, and to accelerate hair re-growth after chemotherapy.

描述（由申请人提供）：本I期申请是我们正在进行的项目的延伸，该项目旨在评估甲状旁腺激素（7-34）刺激和维持毛发生长的安全性和治疗潜力。项目的第一部分包括招募12名正常受试者。6名受试者将局部应用PTH（7-34），其配制在Novasome A乳膏中，50 μ g/gm，持续1周。6名对照受试者将每天使用Novasome A乳膏而不使用药物，持续一周。如果没有不良反应，pTH（7-34）剂量将增加到100微克/克，持续2周。6名对照受试者将继续使用Novasome A乳膏治疗另外2周。受试者将在末次给药后1周返回接受额外的随访访视，以进行临床评估。安全性评价将包括临床观察、实验室结果和自发不良事件报告。预计不会检测到任何不良副作用，该项目将继续进行到下一阶段。本项目第二部分的目的是确定局部应用PTH（7-34）是否能有效减少或预防乳腺癌患者化疗引起的脱发。脱发通常被认为是化疗最令人痛苦的副作用。超过80%的接受化疗的乳腺癌患者认为脱发是治疗中最繁重的方面，一些患者拒绝化疗以避免这种副作用。将招募诊断为I-IV期乳腺癌并计划接受化疗的患者。他们将随机接受化疗前1周和化疗后9周，每天一次局部应用PTH（7-34），该药物配制在Novasome A乳膏或Novasome A乳膏中，不含药物。将评估头皮的任何不良副作用，并收集血液和尿液以监测钙代谢的任何变化，将通过数码摄影和临床评估记录脱发。这项研究的结果应该提供重要的信息，PTH（7-34）是否可以发展成为一种有效的新方法，用于预防或减轻化疗引起的脱发，并加速化疗后的头发再生。