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

描述（由申请人提供）：这项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）刺激和维持头发生长的安全性和治疗潜力。项目的第一部分包括招募12名普通受试者。6名受试者局部使用Novasome A霜中配制的PTH(7-34) 50微克/克，持续1周。6名对照受试者每天使用不含该药的Novasome A乳膏，持续一周。如无不良反应，将pTH（7-34）剂量增加至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2周。受试者将在最后一次给药后1周返回进行额外的随访，以进行临床评估。安全性评估将包括临床观察、实验室结果和自发不良事件报告。预计没有发现不良副作用，项目将继续进行到下一阶段。本项目第二部分的目标是确定局部应用PTH（7-34）对减少或预防乳腺癌患者化疗性脱发是否有效。脱发通常被认为是化疗最令人痛苦的副作用。80%以上接受乳腺癌化疗的患者认为脱发是治疗中最繁重的部分，有些患者为了避免这种副作用而拒绝化疗。被诊断为I-IV期乳腺癌并计划接受化疗的患者将被招募。他们将随机接受化疗前1周和开始化疗后9周，每天一次局部应用PTH(7-34)，该应用由Novasome a乳膏或不含药物的Novasome a乳膏制成。头皮将被评估是否有不良的副作用，血液和尿液将被收集以监测钙代谢的任何改变，脱发将通过数码摄影和临床评估记录。本研究结果应该为PTH（7-34）是否可以发展成为预防或减轻化疗性脱发，以及加速化疗后头发再生的有效新途径提供重要信息。

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.