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

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. Six subjects will apply topical application of PTH (7-34) that is formulated in Novasome A cream 50 microg/gm for one week. Six 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 six control subjects will continue treatment with Novasome A cream for an additional two weeks. Subjects will return for an additional follow-up visit one 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 ill 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 one week before and for nine 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.