[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aromatase-inhibitor-associated-musculoskeletal-symptoms-aimss\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aromatase-inhibitor-associated-musculoskeletal-symptoms-aimss":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100639629","clinical-application-of-vagus-nerve-stimulation-combined-with-immunoregulatory-t-cells-in-alleviating-aromatase-inhibitor-induced-pain-100639629",false,"NCT07593365","Clinical Application of Vagus Nerve Stimulation Combined With Immunoregulatory T Cells in Alleviating Aromatase Inhibitor-Induced Pain","Inclusion Criteria:\n\n1. Female participants aged over 18 years;\n2. Patients with pathologically confirmed stage I-III primary breast cancer;\n3. Patients who have recovered from systemic symptoms related to surgery, radiotherapy, or chemotherapy;\n4. Patients with estrogen receptor- and\u002For progesterone receptor-positive breast cancer who are receiving aromatase inhibitor therapy and have aromatase inhibitor-related musculoskeletal pain, with a score greater than 3 on the Worst Pain item of the Brief Pain Inventory (BPI-WP);\n5. Patients who have received aromatase inhibitor therapy for more than 30 days and are expected to continue treatment for more than 1 year;\n6. Patients who voluntarily agree to participate in this study and sign the informed consent form.\n\n   For participants receiving combined IL-2 treatment, the following additional criterion applies:\n7. Pain relief rate of less than 50% after taVNS treatment and a lower peripheral blood Treg count than before treatment.\n\nExclusion Criteria:\n\n1. Patients with advanced breast cancer;\n2. Patients with other significant organ dysfunction, such as major cardiovascular disease, diabetes mellitus, or hyperthyroidism;\n3. Patients with other cancers;\n4. Patients with a history of fracture or surgery around the painful joint area within the past 6 months;\n5. Patients currently receiving corticosteroids or opioid therapy;\n6. Patients with contraindications to vagus nerve stimulation;\n7. Patients who are unable to communicate normally, such as those with cognitive impairment or hearing impairment;\n8. Patients who have participated in another clinical trial within the past 1 month.\n\n   For participants receiving combined IL-2 treatment, the following additional exclusion criteria apply:\n9. Severe cardiac or renal disease, or hematologic disease;\n10. Previous IL-2-related toxic reaction or allergy;\n11. Use of other biologic agents or immunosuppressive drugs within the past 1 month;\n12. Any other condition that the investigator considers unsuitable for study participation.","FEMALE","18 Years",{"count":18,"type":19},216,"ESTIMATED","INTERVENTIONAL",[22],"NA","The goal of this clinical trial is to learn whether transcutaneous auricular vagus nerve stimulation, also called taVNS, can help relieve aromatase inhibitor-related joint and muscle pain in adult women with hormone receptor-positive breast cancer.\n\nThe main questions this study aims to answer are:\n\n1. Does taVNS reduce pain caused by aromatase inhibitor treatment?\n2. Does taVNS improve quality of life, mood symptoms, and the need for pain medicine?\n3. What side effects or medical problems occur during treatment?\n\nResearchers will compare active taVNS with sham stimulation. Participants in both groups will receive mild electrical stimulation around the ear, but the sham stimulation will be applied to an area not expected to activate the vagus nerve.\n\nParticipants will:\n\n1. Be randomly assigned to active taVNS or sham stimulation\n2. Receive one 30-minute treatment session every day for 28 days\n3. Complete pain, mood, and quality-of-life questionnaires before treatment, after treatment, and during follow-up\n4. Report pain medicine use and any side effects\n5. Provide small blood samples to measure inflammatory markers, T-cell profiles, and tumor markers\n\nParticipants will be followed for up to 6 months after treatment. For some participants who do not have enough pain relief after taVNS, an optional second-stage study may be offered. In this stage, participants may receive low-dose interleukin-2, also called IL-2, by injection every other day for 2 weeks.",[25,26,27],"Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)","Breast Cancer","Pain Alleviation","NOT_YET_RECRUITING","2026-05-13",{"date":31,"type":32},"2026-05-18","ACTUAL",{"date":34,"type":19},"2026-05-06",{"date":36,"type":19},"2029-12-31",{"name":38,"class":39},"Peking University People's Hospital","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":20,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":5},"100525557","early-phase-1-tart-cherry-and-omega-3s-for-aromatase-inhibitor-musculoskeletal-symptoms-100525557","NCT06123286","Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms","An Open Label, Randomized, Waitlist Controlled Trial of Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms","Inclusion Criteria:\n\n* Breast cancer diagnosis (Stage I-III) with any hormonal status.\n* Females aged ≥ 18 years.\n* Currently receiving AI therapy.\n* BMI ≥ 27.\n* Clinical diagnosis of AIMSS.\n* Omega-3 Index \\<8%.\n* Average joint pain score ≥ 4 on the Brief Pain Inventory (BPI) within 7 days of enrollment.\n* Written informed consent obtained from subject and ability and willingness of subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Current use of anticoagulant medications (Including but not limited to Warfarin, Lovenox, Eliquis, Xarelto).\n* Allergy to cherries or fish\u002Ffish products.\n* Lifetime history of rheumatoid arthritis and\u002For inflammatory joint diseases (Including but not limited to reactive arthritis, ankylosing spondylitis, and psoriatic arthritis).\n* Uncontrolled diabetes mellitus as determined by treating physician (with or without the use of glucose lowering medications and\u002For insulin).\n* Lifetime history of stroke or transient ischemic attacks.\n* New use or dose change of oral or topical analgesics in the previous 14 days. (Including but not limited to opioids, non-steroidal anti-inflammatories, acetaminophen, SNRI's, SSRI's, gabapentinoids, tricyclic antidepressants, and muscle relaxants).\n* Oral or intra-articular steroid use in the previous 30 days (Including but not limited to dexamethasone, prednisone, methylprednisolone, triamcinolone, hydrocortisone).\n* History of joint fracture or surgery of the symptomatic joint in the previous 6 months.",{"count":49,"type":19},30,[51],"EARLY_PHASE1","Both Tart Cherry and Omega 3 FAs have better side effect profiles compared to other commonly used medications for AIMSS, such as nonsteroidal anti-inflammatories, steroids, and serotonin norepinephrine reuptake inhibitors. Additionally, in our clinics we often find that patients tend to be more receptive to taking a supplement as opposed to an additional medication. Further, both Tart Cherry concentrate and fish oil have beneficial properties for helping with joint stiffness in general, in addition to other health issues like insomnia.\n\nThere is preliminary evidence in mouse models that when given together, these supplements may have an even greater anti-inflammatory effect than when taken separately14. Although to our knowledge, no human studies have tested this hypothesis. This study has been designed to test the hypothesis that Tart Cherry and fish oil when given in combination over a 12-week period could produce beneficial changes in joint function when compared to Tart Cherry or fish oil in isolation in an obese breast cancer population experiencing AIMSS. Secondary outcomes to be assessed include pain, functional performance, quality of life and cognition.",[26,25,54],"Joint Pain",[56,57,25,58,59,60,61],"Aromatase Inhibitor Therapy","AIMSS","Tart Cherry","Omega 3 Fatty Acids Fish Oil","Female Breast Cancer","Aromatase Inhibitor Arthralgia","RECRUITING","2026-05-01",{"date":65,"type":32},"2026-05-05",{"date":67,"type":32},"2025-09-12",{"date":69,"type":19},"2027-10",{"name":71,"class":39},"Philip Chang"]