[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05417308":3,"trial-entities:NCT05417308":166,"trial-summary:NCT05417308":170},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":42,"study_type":43,"primary_purpose":44,"phases":45,"enrollment_info":47,"interventions":50,"primary_outcomes":76,"secondary_outcomes":81,"sex":114,"minimum_age":115,"maximum_age":116,"healthy_volunteers":117,"eligibility_criteria":118,"std_ages":133,"locations":136,"central_contacts":153,"overall_officials":158,"references":161,"see_also_links":162},"NCT05417308","OSU-20340","Topical or Oral Minoxidil for the Treatment of Endocrine Therapy-Induced Alopecia in Patients With Stage I-IV Breast Cancer","A Pilot Trial of Topical vs Oral Minoxidil for Treatment of Endocrine Therapy-Induced Alopecia in Breast Cancer Patients","RECRUITING","2027-12-31","2026-03","2026-03-10","2023-03-01","Ohio State University Comprehensive Cancer Center","OTHER",true,"This early phase I trial studies the possible benefits and\u002For side effects of topical or oral minoxidil in treating endocrine therapy-induced hair loss (alopecia) in patients with stage I-IV breast cancer. Endocrine therapy-induced alopecia (EIA) is a distressing side effect that leads to reduced quality of life and early cessation of therapy in women undergoing treatment for breast cancer. Patients on endocrine therapy commonly report hair loss or thinning. Minoxidil is a drug that may promote hair growth and reduce hair loss. Oral minoxidil may increase hair density in women with EIA, and work the same as topical minoxidil in treating EIA in patients with breast cancer.","PRIMARY OBJECTIVES:\n\nI. To evaluate the safety and tolerability of low-dose oral minoxidil in patients with breast cancer and EIA.\n\nII. To obtain preliminary data to support whether low-dose oral minoxidil is a reasonable alternative to topical minoxidil in patients with EIA.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients apply minoxidil foam topically to affected areas of the scalp once daily (QD) for up to 12 months in the absence of disease progression or unacceptable toxicity.\n\nARM II: Patients receive minoxidil orally (PO) QD for up to 12 months in the absence of disease progression or unacceptable toxicity.",[19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41],"Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage IA Breast Cancer AJCC v8","Anatomic Stage IB Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage IIA Breast Cancer AJCC v8","Anatomic Stage IIB Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIB Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Endocrine Therapy-Induced Alopecia","Prognostic Stage I Breast Cancer AJCC v8","Prognostic Stage IA Breast Cancer AJCC v8","Prognostic Stage IB Breast Cancer AJCC v8","Prognostic Stage II Breast Cancer AJCC v8","Prognostic Stage IIA Breast Cancer AJCC v8","Prognostic Stage IIB Breast Cancer AJCC v8","Prognostic Stage III Breast Cancer AJCC v8","Prognostic Stage IIIA Breast Cancer AJCC v8","Prognostic Stage IIIB Breast Cancer AJCC v8","Prognostic Stage IIIC Breast Cancer AJCC v8","Prognostic Stage IV Breast Cancer AJCC v8",[],"INTERVENTIONAL","TREATMENT",[46],"EARLY_PHASE1",{"count":48,"type":49},50,"ESTIMATED",[51,62,67,73],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":57},"DRUG","Minoxidil","Applied topically",[56],"Arm I (topical minoxidil)",[58,59,60,61],"Alostil","Loniten","Rogaine","U 10858",{"type":52,"name":53,"description":63,"armGroupLabels":64,"otherNames":66},"Given PO",[65],"Arm II (orally minoxidil)",[58,59,60,61],{"type":14,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"Quality-of-Life Assessment","Ancillary studies",[56,65],[72],"Quality of Life Assessment",{"type":14,"name":74,"description":69,"armGroupLabels":75},"Questionnaire Administration",[56,65],[77],{"measure":78,"description":79,"timeFrame":80},"Proportion of days assigned medication was taken\u002Fapplied","For the oral minoxidil group, the proportion of pills taken will be reported with a 95% confidence interval. For the topical minoxidil group, the proportions of days medication was applied will be reported with a 95% confidence interval.","Up to 12 months",[82,85,89,92,95,99,103,105,109,112,113],{"measure":83,"description":84,"timeFrame":80},"Occurrence of at least one adverse event (AE) of grade 1 or higher","Adverse events will be summarized using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 with reporting of the number and percentage of patients affected. The total number of participants with AEs of any grade, and the total number of participants with grade 3 or higher AEs will be compared between randomized groups using Fisher's exact test.",{"measure":86,"description":87,"timeFrame":88},"Change in hair density","At least mild-to-moderate improvement in hair density from baseline to 3 months as determined by a board-certified dermatologist from photographs. Will construct two-sided 95% confidence intervals for improvements from baseline and differences between randomized groups. Response will be dichotomized as no improvement versus moderate-to-significant improvement.","Baseline to 3 months",{"measure":86,"description":90,"timeFrame":91},"At least mild-to-moderate improvement in hair density from baseline to 6 months as determined by a board-certified dermatologist from photographs. Will construct two-sided 95% confidence intervals for improvements from baseline and differences between randomized groups. Response will be dichotomized as no improvement versus moderate-to-significant improvement.","Baseline to 6 months",{"measure":86,"description":93,"timeFrame":94},"At least mild-to-moderate improvement in hair density from baseline to 12 months as determined by a board-certified dermatologist from photographs. Will construct two-sided 95% confidence intervals for improvements from baseline and differences between randomized groups. Response will be dichotomized as no improvement versus moderate-to-significant improvement.","Baseline to 12 months",{"measure":96,"description":97,"timeFrame":98},"Chemotherapy Alopecia Distress Scale (CADS) score","Patients will complete a a self-administered 17-item questionnaire","At 3 months",{"measure":100,"description":101,"timeFrame":102},"CADS score physical","a self-administered 17-item questionnaire which categorizes questions into 4 subscales including physical","At 6 months",{"measure":100,"description":104,"timeFrame":102},"a self-administered 17-item questionnaire which categorizes questions into 4 subscales including physical relationship",{"measure":106,"description":107,"timeFrame":108},"CADS score emotional","a self-administered 17-item questionnaire which categorizes questions into 4 subscales including emotional relationship","At 12 months",{"measure":110,"description":111,"timeFrame":98},"Patient-reported outcomes","Mean responses to the symptom experience diary questions and the satisfaction items will be compared between groups via t-test.",{"measure":110,"description":111,"timeFrame":102},{"measure":110,"description":111,"timeFrame":108},"FEMALE","18 Years",null,false,{"inclusion":119,"exclusion":124,"raw_text":132},[120,121,122,123],"Women \\>= 18 years of age","Established diagnosis of breast cancer stages I-IV","On endocrine therapy including tamoxifen or aromatase inhibitors with or without concurrent use of ovarian function suppression","Self-reporting hair loss since starting endocrine therapy",[125,126,127,128,129,130,131],"Pregnant or nursing women","Current chemotherapy use or prior chemotherapy use within the last 2 years","History of scarring\u002Fcicatricial alopecia or alopecia areata","Prior use of oral or topical minoxidil","Prior or ongoing use of spironolactone","Known sensitivity to minoxidil","Untreated hypothyroidism or iron deficiency as determined by thyroid stimulating hormone (TSH) with reflex free T4 and ferritin level \\> 40 to be checked at the time of enrolling if not completed in the 12 months prior","Inclusion Criteria:\n\n* Women \\>= 18 years of age\n* Established diagnosis of breast cancer stages I-IV\n* On endocrine therapy including tamoxifen or aromatase inhibitors with or without concurrent use of ovarian function suppression\n* Self-reporting hair loss since starting endocrine therapy\n\nExclusion Criteria:\n\n* Pregnant or nursing women\n* Current chemotherapy use or prior chemotherapy use within the last 2 years\n* History of scarring\u002Fcicatricial alopecia or alopecia areata\n* Prior use of oral or topical minoxidil\n* Prior or ongoing use of spironolactone\n* Known sensitivity to minoxidil\n* Untreated hypothyroidism or iron deficiency as determined by thyroid stimulating hormone (TSH) with reflex free T4 and ferritin level \\> 40 to be checked at the time of enrolling if not completed in the 12 months prior",[134,135],"ADULT","OLDER_ADULT",[137],{"facility":13,"status":8,"city":138,"state":139,"zip":140,"country":141,"contacts":142,"geoPoint":150},"Columbus","Ohio","43210","United States",[143,148],{"name":144,"role":145,"phone":146,"email":147},"Brittany L. Dulmage, MD","CONTACT","614-565-2554","brittany.dulmage@osumc.edu",{"name":144,"role":149},"PRINCIPAL_INVESTIGATOR",{"lat":151,"lon":152},39.96118,-82.99879,[154],{"name":155,"role":145,"phone":156,"email":157},"The Ohio State University Comprehensive Cancer Center","800-293-5066","OSUCCCClinicaltrials@osumc.edu",[159],{"name":160,"affiliation":13,"role":149},"Brittany L Dulmage, MD",[],[163],{"label":164,"url":165},"The Jamesline","http:\u002F\u002Fcancer.osu.edu",{"nct_id":4,"conditions":167,"biomarkers":169},[168],"Breast Carcinoma",[],{"nct_id":4,"found":15,"summary":171,"prompt_version":181},{"design":172,"status":173,"heading":174,"summary":175,"follow_up":176,"word_count":177,"commitments":178,"compensation":179,"drugs_mentioned":180},"This is an interventional study where 50 participants will be randomly assigned to one of two groups: one applying minoxidil foam to the scalp, and the other taking minoxidil by mouth.","completed","Topical or Oral Minoxidil for Hair Loss in Breast Cancer Patients","This study is looking at whether minoxidil, a drug that can help with hair growth, can treat hair loss caused by endocrine therapy in patients with stage I-IV breast cancer. Many women on endocrine therapy (like tamoxifen or aromatase inhibitors) experience hair loss, which can be distressing. Researchers want to see if taking minoxidil by mouth works as well as applying it to the scalp. This early-phase study will also look at how safe and tolerable low-dose oral minoxidil is. You may be able to join if you are a woman aged 18 or older with breast cancer (stages I-IV), are on endocrine therapy, and have noticed hair loss since starting treatment. The main goal is to see how consistently participants take or apply their assigned medication over 12 months.","The study will measure how consistently you take or apply your medication for up to 12 months.",130,"You would either apply minoxidil foam to your scalp once daily or take minoxidil by mouth once daily for up to 12 months.","Not stated in the trial record.",[53],"v2"]