[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osteoporosis-secondary\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osteoporosis-secondary":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100611136","deep-learning-for-musculoskeletal-complications-in-breast-cancer-100611136",false,"NCT07236658","Deep Learning for Musculoskeletal Complications in Breast Cancer","AI-Powered Deep Learning Models for Prospective Prediction of Musculoskeletal Complications After Breast Cancer Surgery: Focus on Lymphedema, Axillary Web Syndrome, Neuropathy, and Pain","Inclusion Criteria:\n\nFemale sex Age ≥18 years Scheduled for surgery due to unilateral breast cancer\n\nExclusion Criteria:\n\nInability to comply with follow-up visits Bilateral breast cancer Male breast cancer Children (\\\u003C18 years) Pregnant women Postpartum women Breastfeeding women Individuals in intensive care Impaired consciousness Legally incapacitated individuals","FEMALE","18 Years",{"count":19,"type":20},133,"ESTIMATED","OBSERVATIONAL","Survival after breast cancer has increased due to early diagnosis and advances in treatment methods. Musculoskeletal problems related to cancer and its treatment constitute a significant part of the daily practice of physiatrists and rehabilitation specialists involved in oncological rehabilitation.\n\nLymphedema can occur at any stage of a patient's life following breast cancer. Patients with breast cancer-related lymphedema require lifelong treatment, and as the stage of lymphedema progresses, response to therapy decreases. Advanced stages of lymphedema negatively affect functional status, and patients experience difficulties in performing activities of daily living.\n\nAxillary web syndrome (AWS) is characterized by a taut cord extending from the axilla to the volar surface of the wrist, typically appearing within the first 8 weeks postoperatively. AWS can complicate the administration of radiotherapy. Shoulder dysfunction may occur independently or in association with AWS. In particular, scapular dyskinesis developing after mastectomy can lead to secondary shoulder conditions such as rotator cuff syndrome or adhesive capsulitis, which are commonly observed in these patients.\n\nPeripheral neuropathy is frequently seen in patients receiving chemotherapy, adversely affecting daily life and sometimes preventing continuation of treatment. Other complications related to chemotherapy and radiotherapy include cardiotoxicity, pulmonary toxicity, fatigue, osteoporosis, and cognitive impairment.\n\nThere are also specific painful syndromes that may occur after breast cancer, including post-mastectomy pain syndrome, phantom breast pain, and musculoskeletal symptoms associated with aromatase inhibitors. All these conditions can significantly impair daily functioning and even hinder continuation of cancer treatment. Therefore, predicting these complications and implementing or developing preventive interventions is crucial.\n\nIf it is possible to predict the early development of lymphedema, axillary web syndrome, peripheral neuropathy, and painful syndromes after breast cancer, early intervention may prevent progression. This study is designed to develop and validate a predictive model using deep learning methods to determine the risk of these complications in patients undergoing breast cancer surgery. Among deep learning architectures, ResNet50, AlexNet, GoogleNet, and UNet, which have been widely used in recent studies, are planned to be implemented.\n\nAdditionally, based on the results of this study, a risk calculation program will be developed, allowing clinicians to input baseline patient data and calculate the individual patient's risk for each complication prior to treatment. No specific risk is expected in the study.",[24,25,26,27,28],"Postmastectomy Lymphedema Syndrome","Breast Cancer Surgery Pain","Osteoporosis Secondary","Shoulder Adhesive Capsulitis","Axillary Web Syndrome","RECRUITING","2026-03-30",{"date":32,"type":33},"2026-03-31","ACTUAL",{"date":35,"type":33},"2025-07-01",{"date":37,"type":20},"2027-01-01",{"name":39,"class":40},"Ankara Etlik City Hospital","OTHER_GOV",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":5},"100612683","vitamin-k-d-chiro-inositol-and--lactalbumin-in-bone-homeostasis-100612683","NCT07256769","Vitamin k, D-chiro Inositol and α-lactalbumin in Bone Homeostasis","Synergic Role of Vitamin k, D-chiro Inositol and α-lactalbumin in Bone Homeostasis in Breast Cancer Patients Treated With Aromatase Inhibitors","Synostea","Inclusion Criteria:\n\n* caucasian women aged between 35 and 70;\n* diagnosed with breast cancer undergoing treatment with aromatase inhibitors or tamoxifen + GnRH analogues or aromatase inhibitors + GnRH analogues not started more than 12 months ago, about to start treatment with oral bone resorption inhibitors (alendronate);\n* vitamin D levels below 30 ng\u002Fml (test carried out no more than 6 months prior to the baseline\u002FT0 visit)\n* patients able to comply with the procedures and\u002For requirements of the study\n* informed consent to participate in the study and data processing, written personally and\u002For through a witness, before any study-specific procedure is carried out\n\nExclusion Criteria:\n\n* uncontrolled diabetes mellitus (HbA1c 8%), severe CRF (eGFR\\\u003C30 ml\u002Fmin);\n* patients with primary or secondary hyperparathyroidism due to CRF;\n* baseline vitamin D levels greater than 30 ng\u002Fml;\n* patients already being treated with anti-resorptive drugs;\n* patients undergoing steroid therapy;\n* patients undergoing treatment with other forms of vitamin D (calcifediol, calcitriol) or who require high doses of calcium (hypoparathyroidism);\n* patients undergoing treatment with drugs that can affect calcium excretion (diuretics);\n* inability to comply with the procedures required by the study.","35 Years","70 Years",{"count":53,"type":20},134,"In women with breast cancer undergoing adjuvant hormone therapy, the marked tissue hypoestrogenism induced by therapy with aromatase inhibitors and\u002For tamoxifen ± GnRH analogues causes a significant acceleration in bone mass loss, with a consequent increased risk of fracture from the first year of therapy. It is therefore essential to start treatment with antiresorptive drugs and calcium and vitamin D supplementation. It has been hypothesized that vitamin K and α-lactalbumin have an effect in improving the absorption of calcium and vitamin D. In addition, vitamin K promotes gamma-carboxylation of osteocalcin, causing its activation and leading to increased incorporation of hydroxyapatite into the bone, resulting in increased calcium uptake from the blood and other tissues. Studies have reported that a combination of alendronate and vitamin K2 can lead to a decrease in the ratio of uncarboxylated osteocalcin to carboxylated osteocalcin, contributing to an increase in BMD, especially in the femoral neck. α-lactalbumin is able to increase the bioaccessibility of calcium due to its ability to prevent its precipitation at the neutral pH present in the absorptive tracts of the small intestine. Furthermore, α- lactalbumin has a binding site for vitamin D3, and the complexes formed by monomers of this protein and vitamin D have shown good stability in the presence of high vitamin concentrations. Inositol is a carbohydrate structurally similar to glucose which, in its isomeric form D-chiro-inositol, acts on bone remodeling by blocking the activation of osteoclasts through inhibition of the binding of RANK-L to its receptor present on pre-osteoclasts. Our hypothesis is that the use of the combination of vitamin K, α- lactalbumin, and D-chiro-inositol should improve the intestinal absorption of calcium and vitamin D, increasing the percentage of patients able to normalize serum levels of vitamin D and urinary calcium excretion (as a parameter of adequate calcium intake). This aspect, together with the direct effect of these components on bone remodeling, could enhance the anti-resorptive effect of standard therapy with bisphosphonates, improving the quantitative and qualitative parameters of bone. Therefore, we design a prospective randomized pilot study to assess efficacy of the combination of vitamin K, α-lactalbumin, and D-chiro-inositol, comparing patients with standard therapy and patients treated with Synostea®",[26,56],"Breast Cancer Females",[58,59,60,61,62,63,64],"Vitamin K","d-chiro-inositol","α-lactalbumin","calcium","cancer treatment induced bone loss","vitamin d","synostea","2025-11-25",{"date":67,"type":33},"2025-12-01",{"date":69,"type":33},"2025-09-29",{"date":71,"type":20},"2028-03-31",{"name":73,"class":74},"Regina Elena Cancer Institute","OTHER"]