[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chemotherapy-effects\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chemotherapy-effects":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":4},"100617371","incidence-of-dysgeusia-in-breast-cancer-patients-undergoing-chemotherapy-100617371",false,"NCT07317752","Incidence of Dysgeusia in Breast Cancer Patients Undergoing Chemotherapy","Incidenza Della Disgeusia Nei Pazienti Affetti da Carcinoma Mammario in Trattamento Chemioterapico: Uno Studio Pilota Prospettico","GustiAmo","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of non-metastatic breast cancer\n* Indication for neoadjuvant or adjuvant chemotherapy as part of standard clinical practice\n* Chemotherapy-naïve patients (no chemotherapy received in the previous 12 months)\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Terminal or metastatic disease\n* Pre-existing taste or smell disorders (e.g., anosmia, dysgeusia, neurological syndromes, etc.)\n* Known allergies to any substances used in taste and chemesthetic function tests (e.g., quinine dihydrochloride, monosodium L-glutamate, capsaicin, etc.)\n* Receiving neoadjuvant or adjuvant chemotherapy within research protocols\n* Lack of signed written informed consent","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to examine how frequently changes in taste occur in people with early-stage breast cancer who receive chemotherapy. It will also look at how these taste changes affect nutrition and quality of life. The main questions this study aims to answer are:\n\n* How many participants develop changes in taste during chemotherapy?\n* How do these changes affect eating habits, nutrition, and daily life?\n\nParticipants are women with non-metastatic breast cancer who are receiving chemotherapy before or after surgery.\n\nResearchers will use standardized taste tests to measure how well participants can perceive different flavors. These tests are designed to provide accurate and reproducible results.\n\nParticipants will:\n\n* Take part in taste tests during their chemotherapy treatment\n* Have their nutritional status evaluated\n* Answer questions about their quality of life",[25,26,27,28,29,30,31,32],"Taste Disorders","Breast Cancer","Quality of Life","Taste Perception","Dysgeusia","Chemotherapy Effects","Nutritional Status","Sensory Testing",[29,34,35,36,37,38,39,40],"Taste disorders","Breast cancer","Quality of life","Taste perception","Chemotherapy effects","Nutritional status","Sensory testing","NOT_YET_RECRUITING","2025-12-24",{"date":44,"type":45},"2026-01-05","ACTUAL",{"date":47,"type":21},"2026-01",{"date":49,"type":21},"2027-12",{"name":51,"class":52},"Azienda Sanitaria Locale CN2 Alba-Bra","OTHER",{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":60,"minAge":18,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100591070","evaluating-bemotuzumab-to-improve-the-efficacy-of-neoadjuvant-chemotherapy-for-triple-negative-breast-cancer-tnbc-100591070","NCT06975644","Evaluating Bemotuzumab to Improve the Efficacy of Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer (TNBC)","A Prospective Clinical Study Evaluating Bemotuzumab Combined With Chemotherapy to Improve the Efficacy of Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer (TNBC)","Inclusion Criteria:\n\n* 1.Voluntarily agree to participate in the clinical study and sign the informed consent form.\n* 2.Female patients aged ≥18 years at the time of signing the informed consent form.\n* 3.Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to enrollment and agree to use a clinically recognized highly effective contraceptive method during the study and for 3 months after the last dose of the study drug.\n* 4.Adequate archival tumor tissue samples for HIM-type analysis (at least 15 unstained tumor biopsy slides from the most recent metastatic lesion; archival primary tumor samples from treatment-naïve patients are acceptable, or re-biopsied specimens may be submitted).\n* 5.Primary breast cancer meeting the following criteria:Histologically confirmed invasive breast cancer.Breast cancer staging (AJCC 8th edition): T1c-4, N0-2, M0.Histopathologically confirmed triple-negative invasive breast cancer (TNBC) meeting all criteria:HER2-negative: IHC 0\u002F1+ or IHC 2+ with negative in situ hybridization (ISH).ER-negative: IHC \\\u003C1%.PR-negative: IHC \\\u003C1%.Unstained tumor sections must be submitted to the central laboratory as per the study protocol for biomarker validation.\n* 6.Willingness to undergo surgery if deemed eligible after neoadjuvant therapy.\n* 7.Adequate organ function as defined by protocol-specified laboratory thresholds.\n* 8.Eastern Cooperative Oncology Group (ECOG) performance status score ≤1 within 7 days prior to the first dose.\n\nExclusion Criteria:\n\n* 1\\. Pathological Staging a) Inflammatory breast cancer.b) Stage IV (metastatic) breast cancer, bilateral breast cancer, or multicentric breast cancer (defined as multifocal tumors involving more than one quadrant with lesions separated by ≥5 cm).\n* 2\\. Tumor-Related Conditions a) Radiologic evidence of tumor invasion into major blood vessels or investigator-determined high risk of life-threatening hemorrhage due to impending vascular compromise.b) Uncontrolled or symptomatic hypercalcemia (\\>1.5 mmol\u002FL ionized calcium, \\>12 mg\u002FdL serum calcium, or albumin-corrected serum calcium \\> upper limit of normal \\[ULN\\]); or symptomatic hypercalcemia requiring ongoing bisphosphonate therapy.c) Other severe concurrent illnesses interfering with treatment plans, including significant pulmonary conditions\u002Fdiseases.\n* 3\\. Prior\u002FConcurrent Anticancer Therapies a) Previous or current systemic antitumor therapy for the current breast cancer (including chemotherapy, molecular targeted therapy, biologic therapy, or investigational agents).b) Participation in another clinical trial within 4 weeks prior to enrollment (3 months for monoclonal antibody trials) or planned participation during this study.c) Prior treatment with immune checkpoint inhibitors other than PD-1\u002FPD-L1 monoclonal antibodies (e.g., CTLA-4 inhibitors) or anti-angiogenic agents (including monoclonal antibodies or TKIs).d) Administration of live\u002Fattenuated vaccines within 28 days before the first dose or anticipated vaccination during the study.\n* 4\\. Medical History\u002FComorbidities a) Other malignancies within the past 5 years requiring systemic\u002Flocal therapy (excluding cured carcinoma in situ, cervical intraepithelial neoplasia, basal\u002Fsquamous skin cancer, or thyroid cancer).b) Major surgery within 28 days before the first dose (defined as requiring ≥3 weeks recovery) or palliative radiotherapy\u002Fablation within 2 weeks.c) Known\u002Fsuspected autoimmune diseases, except:Hypothyroidism managed with hormone replacement.Stable type 1 diabetes with controlled glycemia.d) Active viral hepatitis:HBV: HBsAg(+) or HBcAb(+) with HBV-DNA(+) (except those with HBV-DNA ≤2,500 copies\u002FmL or 500 IU\u002FmL after antiviral therapy).HCV: HCV-Ab(+) with HCV-RNA(+).Coinfection with HBV and HCV.e) HIV infection (HIV-Ab(+)).f) Interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes, pulmonary fibrosis, acute pneumonitis).g) Severe infections:Hospital-required infections (e.g., bacteremia, pneumonia) within 4 weeks.Active CTCAE ≥Grade 2 infections requiring systemic antibiotics within 2 weeks.Unexplained fever \\>38.5°C during screening (tumor-related fever permitted per investigator).Active tuberculosis within 1 year.h) Prior allogeneic bone marrow or solid organ transplantation.i) Peripheral neuropathy ≥Grade 2 (CTCAE v5.0).j) History of neurological\u002Fpsychiatric disorders (e.g., epilepsy, dementia), drug\u002Falcohol abuse.k) Significant cardiac disease:Heart failure (LVEF \\\u003C50%).High-risk arrhythmias (resting HR \\>100 bpm, ventricular tachycardia, Mobitz II\u002Fthird-degree AV block).Unstable angina requiring antianginal therapy.Clinically significant valvular disease.ECG-confirmed transmural myocardial infarction.Uncontrolled hypertension (systolic \\>180 mmHg\u002Fdiastolic \\>100 mmHg).\n* 5\\. Treatment-Related Exclusions a) Systemic immunostimulants (e.g., interferon, interleukin-2) within 4 weeks before the first dose.b) Systemic immunosuppressants (e.g., glucocorticoids, azathioprine) within 2 weeks, except:Topical\u002Finhaled corticosteroids.Physiologic steroid replacement (≤10 mg\u002Fday prednisone equivalent).c) Hypersensitivity to study drug components or severe allergic reactions to monoclonal antibodies.\n* 6\\. Pregnancy\u002FLactation Pregnant\u002Flactating women or women of childbearing potential with positive baseline pregnancy tests or unwilling to use effective contraception.\n* 7\\. Investigator Discretion Any condition deemed by the investigator to compromise protocol compliance or patient safety.","FEMALE","80 Years",{"count":63,"type":21},55,"INTERVENTIONAL",[66],"NA","Evaluating Bemotuzumab to improve the efficacy of neoadjuvant chemotherapy for Triple-Negative Breast Cancer (TNBC)",[69,70,30],"Triple-Negative Breast Cancer (TNBC)","Neoadjuvant Chemotherapy","2025-05-17",{"date":73,"type":45},"2025-05-22",{"date":75,"type":21},"2025-09-01",{"date":77,"type":21},"2026-12-31",{"name":79,"class":52},"Zhejiang Provincial People's Hospital"]