[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631513":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":55,"centralContacts":60,"locations":65,"responsibleParty":84,"collaborators":42,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":42,"eligibilityCriteria":91,"healthyVolunteers":88,"sex":92,"minAge":93,"maxAge":42,"enrollmentInfo":94,"targetDuration":42,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":68,"whyStopped":42,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Thomas Jefferson University","OTHER",[8,14,19,24,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Tai Chi\u002FQi Gong Alone","EXPERIMENTAL","This arm includes participants who respond to Tai Chi\u002FQi Gong in Stage 1. In Stage 2, participants attended Tai Chi\u002FQi Gong sessions twice weekly for 8 weeks. Using a manualized approach, each class will provide objectives and learning activities related to sequentially learning a specific set of Tai Chi\u002FQi Gong movements weekly.",[13],"Behavioral: Tai Chi\u002FQi Gong",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2: Tai Chi\u002FQi Gong plus α- Lipoic acid (ALA)","This arm includes participants who do no respond to Tai Chi\u002FQi Gong in Stage 1. In Stage 1, participants attend Tai Chi\u002FQi Gong sessions twice weekly for 8 weeks. In Stage 2, nonresponders to Tai Chi\u002FQi Gong continue Tai Chi\u002FQi Gong and are randomized to receive daily alpha-lipoic acid (ALA) supplementation for 8 weeks.",[13,18],"Dietary Supplement: α- Lipoic acid",{"label":20,"type":10,"description":21,"interventionNames":22},"Arm 3: Tai Chi\u002FQi Gong plus Acupuncture","This arm includes participants who do no respond to Tai Chi\u002FQi Gong in Stage 1. In Stage 1, participants attend Tai Chi\u002FQi Gong sessions twice weekly for 8 weeks. In Stage 2, nonresponders to Tai Chi\u002FQi Gong continue Tai Chi\u002FQi Gong and are randomized to receive acupuncture treatments for 8 weeks.",[13,23],"Procedure: Acupuncture",{"label":25,"type":10,"description":26,"interventionNames":27},"Arm 4: α- Lipoic acid (ALA) Alone","This arm includes participants who respond to alpha-lipoic acid (ALA) in Stage 1. In Stage 1, participants receive oral alpha-lipoic acid (ALA) supplementation daily for 8 weeks. In Stage 2, responders to ALA continue daily ALA supplementation for an additional 8 weeks.",[18],{"label":29,"type":10,"description":30,"interventionNames":31},"Arm 5: α- Lipoic acid (ALA) plus Tai Chi\u002FQi Gong","This arm includes participants who do no respond to alpha-lipoic acid (ALA) in Stage 1. In Stage 1, participants receive oral alpha-lipoic acid (ALA) supplementation for 8 weeks. In Stage 2, nonresponders to ALA continue ALA supplementation and are randomized to receive Tai Chi\u002FQi Gong sessions twice weekly for 8 weeks.",[13,18],{"label":33,"type":10,"description":34,"interventionNames":35},"Arm 6: α- Lipoic acid (ALA) plus Acupuncture","This arm includes participants who do no respond to alpha-lipoic acid (ALA) in Stage 1. In Stage 1, participants receive oral alpha-lipoic acid (ALA) supplementation for 8 weeks. In Stage 2, nonresponders to ALA continue ALA supplementation and are randomized to receive acupuncture treatments for 8 weeks.",[18,23],[37,43,50],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"BEHAVIORAL","Tai Chi\u002FQi Gong","Participants will be asked to attend Tai Chi\u002FQi Gong classes for one hour twice a week for 8 weeks over Zoom video conferencing or in person. Using a manualized approach, each class will provide objectives and learning activities related to sequentially learning a specific set of Tai Chi\u002FQi Gong movements with verification of skills attainment weekly24. Six key elements will be emphasized: 1) Mindfulness; 2) Postural alignment; 3) Natural breathing; 4) Active relaxation, 5) Slow movement, and 6) Integrated movement.",[9,15,20,29],null,{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"DIETARY_SUPPLEMENT","α- Lipoic acid","Participants will be provided with Lipoic Acid Supplement (300 mg) bottles, with instructions to take two tablets daily, 30 minutes before breakfast.",[15,25,29,33],[49],"ALA",{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":42},"PROCEDURE","Acupuncture","participants will receive acupuncture treatments for 8 weeks. After disinfecting the skin with an alcohol swab, acupuncturists inserted filiform 0.16 mm × 15 mm (or 30 mm) sterilized, disposable acupuncture needles in the ear and Ba Feng points; 0.20 mm × 30 mm (or 40 mm) sterilized, disposable acupuncture needles will be inserted at body points. Needles for body points will be inserted 0.5 inches into the skin and left for 30 min after achieving de qi, a sensation of achiness, soreness and heaviness.",[20,33],[56],{"name":57,"affiliation":58,"role":59},"Kuang-Yi Wen, PhD","Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University","PRINCIPAL_INVESTIGATOR",[61],{"name":57,"role":62,"phone":63,"phoneExt":42,"email":64},"CONTACT","215-503-4623","Kuang-Yi.Wen@Jefferson.edu",[66],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Sidney Kimmel Cancer Center at Thomas Jefferson University","RECRUITING","Philadelphia","Pennsylvania","19107","United States","US",{"type":75,"coordinates":76},"Point",[77,78],-75.16362,39.95238,{"lat":78,"lon":77},[81],{"name":82,"role":62,"phone":83,"phoneExt":42,"email":64},"Kuang-Yi Wen, MD","2155034623",{"type":85,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100631513","optimizing-integrative-oncology-approaches-to-address-chemotherapy-induced-peripheral-neuropathy-in-gastrointestinal-gi-cancer-patients-a-smart-pilot-study-100631513",false,"NCT07501663","Optimizing Integrative Oncology Approaches to Address Chemotherapy-induced Peripheral Neuropathy in Gastrointestinal (GI) Cancer Patients: A SMART Pilot Study","Inclusion Criteria:\n\n* Individuals must meet all the following inclusion criteria in order to be eligible to participate in the study:\n\n  * Age 18 years or older,\n  * Self-reported moderate (≥ 2\u002F4) numbness and tingling on the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Numbness and Tingling Severity Item in the previous week,\n  * At least three months since the last receipt of neurotoxic chemotherapy,\n  * Prior receipt of paclitaxel, docetaxel, cisplatin, oxaliplatin, nab-paclitaxel, or carboplatin for the treatment of stage I-III Gastrointestinal (GI) cancers,\n  * Speaking\u002Freading English.\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this study:\n\n  * Prognosis of ≤ 3 months,\n  * Documented neuropathy attributed to other causes (e.g., diabetic neuropathy),\n  * Intention to initiate a new prescription of duloxetine or other pain medications (i.e., first-line treatment for CIPN pain) during the study period; however, participants may continue on duloxetine or other pain medications if initiated at least 8 weeks before study enrollment, with no change in dose, and reporting unmanaged CIPN (i.e., ≥ 2\u002F4) PRO-CTCAE numbness\u002Ftingling severity in the last week,\n  * Currently using alcohol (ethyl), which means regular alcohol consumption (defined as ≥7 drinks\u002Fweek for women, ≥14 drinks\u002Fweek for men, or binge drinking \\>3 drinks per occasion at least weekly) within the past 3 months, or current alcohol use disorder or inability\u002Funwillingness to abstain from alcohol during the study intervention period,\n  * Currently using calcium salts, iron preparations or magnesium salts orally,\n  * With thyroid disorders, particularly those with hypo- or hyperthyroidism,\n  * With thiamine deficiency, as assessed and verified by the physician.","ALL","18 Years",{"count":95,"type":96},60,"ESTIMATED","INTERVENTIONAL",[99],"NA","The objective of the proposed pilot is to test the feasibility, acceptability, and preliminary efficacy of a 16-week sequential, multiple assessment randomized trial (SMART), which includes virtual Tai Chi\u002FQi Gong or α- Lipoic acid (ALA) supplements as an initial treatment, and acupuncture as the additional treatment, that examines a stepped-care intervention to address CIPN.",[102],"Peripheral Neuropathy",[104,105,106,107,108,49,109,52,110],"Gastrointestinal","Peripheral Neuropathy in Gastrointestinal","Chemotherapy-induced Peripheral Neuropathy","CIPN","Tai Chi","Qi Gong","SMART","2026-04-09",{"date":113,"type":114},"2026-04-14","ACTUAL",{"date":116,"type":114},"2026-01-20",{"date":118,"type":96},"2027-04",{"name":58,"class":6},1]