[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654960":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":32,"studyPopulation":21,"armGroups":33,"interventions":45,"overallOfficials":21,"centralContacts":52,"locations":21,"responsibleParty":62,"collaborators":21,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":21,"enrollmentInfo":76,"targetDuration":21,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":88,"whyStopped":21,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":21},{"fullName":5,"class":6},"Pharos University in Alexandria","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Changes in Serum Biomarkers of Muscle-Bone Crosstalk","Serum concentration changes of key muscle-bone crosstalk mediators, specifically Myostatin (MSTN) and Osteocalcin (OCN), evaluated via enzyme-linked immunosorbent assay (ELISA) to assess the impact of physical therapy on cachexia-induced muscle-skeletal degradation.","3 month",[14,18],{"measure":15,"description":16,"timeFrame":17},"Change in Muscle Strength","Measured using a hand-grip dynamomete","Baseline and 3 months post-intervention",{"measure":19,"description":20,"timeFrame":17},"Change in Bone Mineral Density (BMD","Measured using DEXA scan at the lumbar spine",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":25,"primaryPurpose":26,"observationalModel":21,"timePerspective":21,"maskingInfo":27},"RANDOMIZED","PARALLEL","Participants will be randomly assigned to one of two parallel groups in a 1:1 ratio: an Experimental Group (receiving a structured 3-month physical therapy exercise protocol alongside neoadjuvant chemotherapy and nutritional support) or a Control Group (receiving standard neoadjuvant chemotherapy and nutritional support alone)","PREVENTION",{"masking":28,"maskingDescription":29,"whoMasked":30},"SINGLE","Due to the nature of the physical therapy exercise intervention, participants, care providers, and investigators cannot be blinded to group assignment. To minimize assessment bias, primary and secondary outcomes-including ELISA laboratory biomarker analyses, DEXA body composition scans, and functional performance tests (6MWT, TUG, SPPB)-will be evaluated by independent outcomes assessors who are kept blinded to participant group allocation throughout the trial.",[31],"OUTCOMES_ASSESSOR","Cancer-induced cachexia (CIC) is a complex multifactorial syndrome characterized by progressive loss of skeletal muscle mass, systemic inflammation, metabolic dysregulation, and functional decline. The physiological interplay between skeletal muscle and bone tissue-known as muscle-bone crosstalk-is regulated through humoral signaling pathways involving myokines and osteokines. Key myokines, such as myostatin (an inhibitor of muscle growth), Interleukin-15 (IL-15, which promotes hypertrophy and fat oxidation), and decorin (which binds to myostatin to promote muscle growth), play pivotal roles in maintaining musculoskeletal homeostasis. Contractile activity during physical exercise can favorably modulate these myokine levels, reducing protein degradation and improving metabolic function. Despite the established systemic benefits of physical exercise, significant knowledge gaps remain regarding the clinical efficacy of structured physical therapy protocols specifically targeting muscle-bone crosstalk in young to middle-aged adults undergoing active cancer treatment. Furthermore, there is limited clinical data quantifying exercise-induced biological changes in circulating myokines (e.g., IL-15, decorin, SPARC) within non-metastatic cancer populations receiving neoadjuvant chemotherapy. This study is designed as a prospective Randomized Controlled Trial (RCT) to evaluate the therapeutic potential of a 3-month exercise intervention in patients aged 40-60 years with Grade 2\u002F3 non-metastatic cancer undergoing neoadjuvant chemotherapy. Eligible participants are randomized into two parallel groups: Control Group: Receives standard care consisting of neoadjuvant chemotherapy accompanied by a structured nutritional support course following cachexia onset. Experimental Group: Receives a progressive 3-month physical therapy program in addition to standard neoadjuvant chemotherapy and nutritional support following cachexia onset. The 3-month physical therapy intervention combines structured aerobic and resistance training protocols: Aerobic Exercise: Treadmill walking performed 3 to 5 times per week (aiming for 150 minutes per week) at a progressive intensity ranging between 40% and 85% of maximum heart rate ($\\\\text{HR}\\_{\\\\text{max}}$). Resistance Exercise: Progressive strength training performed 2 to 3 times per week consisting of 2 sets of 8 to 10 repetitions at 50% to 70% of 1-repetition maximum (1RM)",[34,40],{"label":35,"type":36,"description":37,"interventionNames":38},"Experimental Group","EXPERIMENTAL","Participants receive a structured 3-month physical therapy exercise protocol combining aerobic treadmill training (3-5 days\u002Fweek) and progressive resistance training (2-3 days\u002Fweek) alongside standard neoadjuvant chemotherapy and nutritional support.",[39],"Other: Structured Physical Therapy Exercise Program",{"label":41,"type":42,"description":43,"interventionNames":44},"control group","PLACEBO_COMPARATOR","Participants receive standard neoadjuvant chemotherapy accompanied by standard nutritional support following cachexia onset, without participating in the structured physical therapy program",[39],[46],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Structured Physical Therapy Exercise Program","Experimental Group):\n\nA 3-month progressive physical therapy program consisting of aerobic exercise (treadmill walking 3-5 times per week, 150 min\u002Fweek total, at 40%-85% HRmax) and resistance exercise (2-3 times per week, 2 sets of 8-10 repetitions at 50%-70% 1RM) combined with standard neoadjuvant chemotherapy and nutritional support Standard care comprising neoadjuvant chemotherapy protocols along with routine clinical nutritional support provided upon cachexia diagnosis, with no formal exercise intervention.",[35,41],[51],"Standard Care and Nutritional Support",[53,58],{"name":54,"role":55,"phone":56,"phoneExt":21,"email":57},"ola E elgohary, Lecturer","CONTACT","01227191398","ola.elgohary@pua.edu.eg",{"name":59,"role":55,"phone":60,"phoneExt":21,"email":61},"lamia S tolba, Lecturer","01007215433","lamiaa.said@pua.edu.eg",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Ola Mohamed Elsayed Elgohary","lectuerer of physical therapy","100654960","targeting-muscle-bone-crosstalk-through-physical-therapy-in-cancer-cachexia-100654960",false,"NCT07807306","Targeting Muscle-Bone Crosstalk Through Physical Therapy in Cancer Cachexia","Targeting Muscle-Bone Crosstalk: The Potential of Physical Therapy in Managing Cancer-Induced Cachexia","PU-PTCC","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n\nConfirmed diagnosis of non-metastatic cancer (Grade 2 or Grade 3).\n\nDiagnosed with Cancer-Induced Cachexia (CIC) based on international consensus criteria (weight loss \\>5% in past 6 months, OR weight loss \\>2% in individuals with BMI \\\u003C20 kg\u002Fm², OR appendicular skeletal muscle index consistent with sarcopenia).\n\nScheduled for or currently receiving standard neoadjuvant chemotherapy.\n\nAbility to provide written informed consent and follow a structured physical therapy program.\n\nECOG Performance Status of 0 to 2.\n\nExclusion Criteria:\n\n* Evidence of distant tumor metastasis (Grade 4 cancer).\n\nSevere orthopedic, neurological, or cardiovascular conditions preventing participation in safe physical therapy exercise.\n\nUncontrolled cardiovascular disease (e.g., unstable angina, recent myocardial infarction, severe cardiac arrhythmias).\n\nSevere bone metastases or pathologic fracture risk that contraindicates weight-bearing exercises.\n\nPrior participation in regular structured aerobic or resistance exercise training within the past 6 months.\n\nCognitive impairment or psychiatric conditions interfering with treatment compliance or informed consent.","ALL","18 Years",{"count":77,"type":78},40,"ESTIMATED","INTERVENTIONAL",[81],"NA","This study investigates the role of a structured physical therapy (PT) program in managing cancer-induced cachexia (CIC) by targeting muscle-bone crosstalk. Cancer-induced cachexia leads to severe muscle wasting, systemic inflammation, and functional decline, which often limits treatment tolerance and quality of life. While exercise is known to attenuate protein breakdown and modulate muscle-derived cytokines (myokines), its specific impact on muscle-bone signaling in non-metastatic cancer patients undergoing chemotherapy remains underexplored. In this randomized controlled trial (RCT), patients aged 40 to 60 receiving neoadjuvant chemotherapy are assigned to either a control group receiving standard chemotherapy and nutritional counseling, or an experimental group receiving a progressive 3-month exercise program (combining aerobic treadmill training and resistance exercises) alongside standard care. The study aims to evaluate changes in biomarker levels (such as myokines and osteokines) and functional physical outcomes to determine whether targeted exercise can effectively attenuate cachexia and improve rehabilitation outcomes prior to surgery",[84,85],"Cancer Cachexia","Sarcopenia",[87],"cancer,sarcopenia,pt","NOT_YET_RECRUITING","2026-09-01",{"date":91,"type":92},"2026-09-08","ACTUAL",{"date":94,"type":78},"2026-10-29",{"date":96,"type":78},"2027-02-02",{"name":5,"class":6}]