[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-metastatic-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-metastatic-breast-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,73],{"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":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100618067","efficacy-of-the-maeva-program-meditation-acceptance-and-commitment-to-values-among-patients-treated-for-breast-cancer-100618067",false,"NCT07326800","Efficacy of the MAEva Program (Meditation, Acceptance, and Commitment to Values) Among Patients Treated For Breast Cancer.","Efficacy of the MAEva Program (Meditation, Acceptance, and Commitment to Values) Among Patients Treated For Breast Cancer : a Randomized, Multicenter Clinical Trial","MAEva-MCT","Inclusion Criteria:\n\n* Patients with non-metastatic breast cancer,\n* Patients who are able and willing to follow all study procedures in accordance with the protocol,\n* Patients who have understood, signed, and dated the consent form,\n* Patients who are affiliated with the social security system,\n* Patients who are able to remain seated during the 1.5-hour sessions.\n\nExclusion Criteria:\n\n* Patients with metastatic cancer,\n* Presence of an acute psychiatric disorder: acute depression, unstable bipolar disorder, psychotic disorder (delusions, hallucinations), etc.\n* Presence of recurrent uncontrolled panic attacks (particularly related to hypochondriacal concerns),\n* Insufficient attentional resources for meditation: major attention, memory, or reasoning disorders,\n* Presence of cognitive and neurocognitive disorders and deficits,\n* Presence of deafness,\n* Current participation in another mindfulness program,\n* Persons deprived of their liberty or under guardianship (including curatorship),\n* Inability to undergo medical monitoring for the trial for geographical, social, or psychological reasons.","FEMALE","18 Years",{"count":20,"type":21},190,"ESTIMATED","INTERVENTIONAL",[24],"NA","The MAEva program combines Acceptance and Committment Therapy (ACT) and mindfulness practices. It is an open and circular intervention, in three sessions (Mindfulness, Acceptance, and Commitment to values). It is designed for cancer patients and was the subject of an initial study that explored its feasibility and acceptability, as well as the initial results on psychological well-being.\n\nThis randomized, multicenter clinical trial is necessary to demonstrate the efficacy of the MAEva program compared to a discussion group with non metastatic breast cancer patients.\n\nPatients will be included and randomized into two arms:\n\n* In the first arm, patients will have the opportunity to participate in the MAEva program for nine consecutive weeks.\n* and the second arm patients will have the opportunity to participate in a discussion group for nine consecutive weeks.\n\nThe patients will be able to attend one session per week for nine consecutive weeks.\n\nQuantitative assessments of quality of life, symptoms of stress, anxiety, and depression, as well as psychological flexibility, will be conducted before the first session, after 3 weeks, 9 weeks, and 12 weeks.\n\nAlso, a qualitative analysis will be conducted based on satisfaction questionnaire and a semistructured interview performed after the end of the program. The interview analysis will described the extent to which the intervention is adapted to the realities on the ground and the needs of the target population. It will enable to identify how patients appropriate the psychological flexibility processes taught in the program in relation to the conceptual framework of ACT therapy (i.e., contact with the present moment, self-as-context, acceptance, defusion, values, and committed action) and integrate them into their daily lives.",[27],"Non Metastatic Breast Cancer",[29,30,31,32,33],"Cancer","MAEva program","Mindfulness","Acceptance and commitment therapy","Quality of life","RECRUITING","2026-04-13",{"date":37,"type":38},"2026-04-16","ACTUAL",{"date":40,"type":38},"2026-02-16",{"date":42,"type":21},"2029-02-16",{"name":44,"class":45},"Institut de Cancérologie de Lorraine","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":5},"100458986","phase-1-rage-inhibition-to-decrease-cardiotoxicity-in-women-with-early-breast-cancer-100458986","NCT05256745","RAGE Inhibition to Decrease Cardiotoxicity in Women With Early Breast Cancer","RAGE Inhibition to Decrease Cancer Therapy Related Cardio Toxicity in Women With Early Breast Cancer","RAGE","Inclusion Criteria:\n\n1. Patients must have clinical or pathologic stage I-III, histologically confirmed breast cancer, with any ER (estrogen-receptor), PR (progesterone receptors), or HER2 (human epidermal growth factor receptor 2) status who are planned to receive chemotherapy in the adjuvant or neoadjuvant setting.\n\n   a. Chemotherapy regimens administered per USPI (United States Prescribing Information) label: i. Dose dense doxorubicin plus cyclophosphamide followed by paclitaxel (ddAC\u002FddT) for 8 cycles ii. Docetaxel plus cyclophosphamide (TC) for 4-6 cycles iii. Docetaxel, carboplatin, trastuzumab, and pertuzumab (TCHP)for 6 cycles iv. Chemotherapy regimen that includes ddAC, given at the end of the chemotherapy plan \\[can include: (1)weekly carboplatin + paclitaxel + pembrolizumab followed by pembrolizumab + dose dense doxorubicin and cyclophosphamide; (2) weekly carboplatin + paclitaxel followed by dose dense doxorubicin and cyclophosphamide; (3) weekly or dd paclitaxel followed by dose dense doxorubicin and cyclophosphamide\\]\n2. Patients must have had no prior chemotherapy\u002Fradiotherapy\u002For systemic therapy for early stage breast cancer, or any other malignancy\n3. Age ≥18 years.\n4. ECOG (Eastern Cooperative Oncology Group) performance status ≤2 (Karnofsky ≥60%, see Appendix D).\n5. Patients must have normal organ and marrow function as defined below:\n\n   1. Leukocytes ≥3,000\u002FmcL (microliter)\n   2. Absolute neutrophil count ≥1,500\u002FmcL\n   3. Platelets ≥100,000\u002FmcL\n   4. Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN)\n   5. AST(SGOT) (aspartate transaminase)\u002FALT(SGPT) (alanine aminotransferase) ≤1.5 × institutional ULN\n   6. Glomerular filtration rate (GFR) ≥60 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal.\n6. Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial. If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated. If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load.\n7. No pre-existing neurodegenerative disease or impairment, including history of CVA (cerebrovascular accident), or head injury.\n8. No psychiatric disorders which could interfere with their ability to consent. (Allowed psychiatric disorders may include but are not limited to: anxiety, depression, obsessive compulsive disorder, ADHD; as long as the disorder does not affect the ability to consent). Any other psychiatric disorders should be discussed with the Principal Investigator (PI) and will be allowed at the discretion of the PI.\n9. The effects of azeliragon on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n10. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Patients who have had prior chemotherapy, radiotherapy, systemic therapy, or hormonal therapy\n2. Patients with Stage IV breast cancer\n3. Patients who are receiving any other investigational agents.\n4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to azeliragon, or the standard of care chemotherapy assigned, including: docetaxel, cyclophosphamide, carboplatin, doxorubicin, paclitaxel, trastuzumab, pertuzumab, pembrolizumab.\n5. Patients receiving any medications or substances that are strong CYP2C8 inhibitors are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. Subjects who discontinue a strong CYP2C8 inhibitor must have discontinued the drug for at least 5 days or 5 half-lives of the drug, whichever is longer, before the first dose of study drug.\n6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, neurogenerative disease\u002Fimpairment, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n7. Pregnant women are excluded from this study as the risks of azeliragon to a fetus are unknown. There is unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with azeliragon; breastfeeding should be discontinued if the mother is treated with azeliragon. These potential risks may also apply to other agents used in this study.\n8. History of cancer within the last 5 years except adequately treated cervical carcinoma-in-situ, or cutaneous basal cell or squamous cell cancer.",{"count":56,"type":21},48,[58,59],"PHASE1","PHASE2","This is a pilot study to evaluate the effects of azeliragon to decrease cardiac toxicity from chemotherapy and the safety of azelirgaon when given with chemotherapy. The Investigators hypothesize that there will be no significant interaction with Azeliragon and chemotherapy and that targeting the RAGE pathway will decrease anthracycline related cardiotoxicity and chemotherapy related cognitive decline.",[62,63],"Cancer Related Cognitive Decline","Non-metastatic Breast Cancer","2025-12-23",{"date":66,"type":38},"2025-12-24",{"date":68,"type":38},"2023-06-06",{"date":70,"type":21},"2026-12",{"name":72,"class":45},"Georgetown University",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":46},"100546890","comparison-of-the-efficacy-of-cryotherapy-combined-with-compression-in-preventing-neuropathy-100546890","NCT06400849","Comparison of the Efficacy of Cryotherapy Combined With Compression in Preventing Neuropathy","Comparison of the Efficacy of Cryotherapy Combined With Compression in Preventing the Development of Paclitaxel-induced Peripheral Neuropathy in Non-metastatic Breast Cancer: A Prospective, Single-centre, Self-controlled Trial","ARIANE","Inclusion Criteria:\n\n* Patient age ≥ 18 years ;\n* Performance Status (PS): 0 to 2\n* Women with localised or locally advanced breast cancer of any histology\n* Indication for treatment with 3 to 4 cycles of paclitaxel (+\u002F- trastuzumab, pertuzumab, carboplatin or endoxan) as adjuvant or neoadjuvant therapy. The choice of the number of cycles will be at the investigator's discretion.\n* Symmetry of upper limb peripheral neuropathy grade ≤ 1 according to CTCAE version 5.0 at inclusion.\n* Presence of radial pulses in the upper limbs.\n* Presence of tibio-posterior and tibio-anterior ankle pulses or ankle systolic pressure index \\> 0.9.\n* Patient has read the information note and signed the informed consent form.\n* The patient is covered by social security.\n\nExclusion Criteria:\n\n* Patient age \\\u003C 18 years\n* Patients diagnosed with metastatic or bilateral breast cancer\n* Patients with metastatic disease of any location\n* Peripheral neuropathy grade ≥ 2 according to CTCAE version 5.0 of the upper or lower limbs\n* Patients with asymmetric upper limb peripheral neuropathy grade \\> 1 according to CTCAE version 5.0 at inclusion.\n\n  \\*In the case of asymmetry of the lower limbs of grade \\> 1 according to CTCAE version 5.0, the patient will not be considered a failure in selection but the corresponding secondary criteria will not be analysed.\n* Patients with underlying medical conditions that could potentially cause peripheral neuropathy (diabetes mellitus, chronic alcoholism, unilateral lymphoedema or postherpetic neuralgia), or any other reason based on the investigator's judgement.\n* Diagnosed Raynaud's syndrome\n* Obstructive arterial disease of the lower limbs\n* History of myocardial infarction\n* Patients already using compression foot socks\n* Vulnerable populations and participants defined in Articles 64 to 68 of Regulation (EU) 2017\u002F745 of the European Parliament and of the Council of 5 April 2017:\n\n  * Pregnant women\n  * Incapacitated participants who have not given their free and informed consent or refused to do so before the onset of their incapacity, who do not fall under the provisions of Article 64 ;\n  * Pregnant or breast-feeding women who are not covered by the provisions of article 66;\n  * Persons of full age who are the subject of a legal protection measure or who are unable to express their consent.","99 Years",{"count":83,"type":21},60,[24],"Breast cancer is the most frequently diagnosed cancer in the world. In France, 58,000 new cases were detected in 2018. Breast cancer is therefore the most common cancer in women. The 5-year survival rate for all stages combined is 88%. These excellent survival figures have been achieved thanks to improvements in treatment, including the advent of chemotherapy. The majority of patients will be cured of their cancer, so post-cancer quality of life is a major issue, hence the importance of trying to reduce long-term sequelae.\n\nTaxanes are one of the main cytotoxic anticancer agents used in the treatment of breast cancer. However, taxanes have a direct effect on the central and peripheral nervous systems and can induce chemotherapy-induced peripheral neuropathy (CIPN). The mechanisms of NPIC by taxanes are not fully understood. CINP is manifested by symptoms of paresthesia, numbness, burning, pain, altered temperature perception, myalgia, myopathy, fine motor difficulties, gait and balance disturbances, muscle weakness in the lower limbs and\u002For functional decline.\n\nNPIC occurs in 80 to 97% of patients treated with taxanes and is the main limiting toxicity during paclitaxel administration. NPIC often leads to postponement or reduction of dose, or even discontinuation of treatment. In addition, NPIC may last for several months or even years after the end of anti-cancer chemotherapy and represents the main long-term sequelae. This can promote and\u002For exacerbate symptoms of psychological distress (depressive symptoms and symptoms of anxiety) and lead to a reduction in quality of life (QoL). Prevention of NIPC is therefore a major issue in breast cancer treatment. According to the 2014 guidelines from the American Society of Clinical Oncology, prevention and treatment of IPN are inadequate with current weapons, and there is an urgent need to evaluate and find new methods of prevention. One of the challenges in the management of NIPC will be to reduce the pain induced without diminishing the anti-tumour effect of anti-cancer agents.\n\nIn recent years, the effectiveness of cryotherapy using a frozen glove and compression therapy using surgical gloves (SG) in preventing taxane-induced PINC has been reported. During chemotherapy, patients wore a frozen glove on one hand and two surgical gloves of the same size on the other hand continuously. Recent study explained how compression therapy and cryotherapy shared a similar mechanism of reducing drug exposure due to vasoconstriction during paclitaxel infusion. The low temperature associated with cryotherapy would reduce paclitaxel uptake and peripheral nerve damage, or mechanotransduction, and allow a reduction in NIPC.\n\nTo date, no study has investigated the efficacy of combining the two means of prevention. The current standard at the Centre Antoine Lacassagne is cryotherapy. The aim of this prospective, self-controlled trial is therefore to compare the efficacy of cryotherapy combined with compression prevention versus cryotherapy alone in preventing paclitaxel-induced peripheral neuropathy in patients undergoing adjuvant treatment for localised breast cancer.",[63],[88,89,90,91,92],"Non-metastatic breast cancer","Peripheral neuropathy","paclitaxel","cryotherapy","compression therapy","2025-12-17",{"date":64,"type":38},{"date":96,"type":38},"2024-04-04",{"date":98,"type":21},"2027-06-04",{"name":100,"class":45},"Centre Antoine Lacassagne"]