[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06840262":3,"trial-entities:NCT06840262":102,"trial-summary:NCT06840262":105},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":50,"secondary_outcomes":55,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":73,"locations":76,"central_contacts":94,"overall_officials":95,"references":98,"see_also_links":99},"NCT06840262","2019-0971","Target Muscle Re-innervation and Regenerative Peripheral Nerve Interfaces Alone and in Combination for the Treatment of Residual and Phantom Limb Pain in Cancer Patients Who Have Received an Amputation","Targeted Muscle Reinnervation (TMR) Versus Regenerative Peripheral Nerve Interfaces (RPNI) Versus the Combined Technique of TMR-RPNI to Reduce Chronic and Phantom Limb Pain in Oncologic Amputees: A Randomized Control Pilot Study","RECRUITING","2027-02-02","2025-09","2025-09-05","2020-08-10","M.D. Anderson Cancer Center","OTHER",true,"This clinical trial evaluates two surgical techniques (targeted muscle re-innervation \\[TMR\\] and regenerative peripheral nerve interfaces \\[RPNI\\]) alone and in combination for the alleviation of chronic residual limb and phantom limb pain in cancer patients who have had an amputation. Chronic residual limb pain and phantom limb pain are debilitating outcomes of traumatic and oncologic amputation. Emerging microsurgical treatments for post-amputation pain are very promising. TMR and RPNI are both approved surgical techniques that involve connecting cut nerves to parts of the muscle as a way to heal and protect the nerves. This trial evaluates these techniques alone and in combination for the treatment of residual and phantom limb pain in cancer patients who have received an amputation.","PRIMARY OBJECTIVE:\n\nDetermine the relative effectiveness of three surgical techniques, TMR, RPNI, and TMR with RPNI, on chronic and phantom limb pain in the oncologic amputee using the validated Numerical Rating Scale (NRS) and Patient-Reported Outcomes Measurement Information System (PROMIS) Behavior, Intensity, Interference, and Global Health Forms.\n\nSECONDARY OBJECTIVES:\n\nI. To estimate the rate and total quantity of any pain medication use among oncology amputees who received one of the three surgical techniques.\n\nII. To estimate the rate of prosthetic use among oncologic amputees. III. To compare NRS and PROMIS among three surgical techniques to calculate the effect size and project the sample size which will be used to plan a multi-institutional study.\n\nOUTLINE: Patients are randomized to 1 of 3 arms.\n\nARM 1: Patients undergo TMR procedure.\n\nARM 2: Patients undergo RPNI procedure.\n\nARM 3: Patients undergo TMR in combination with RPNI.\n\nAfter completion of study procedure, patients are followed up at 3, 6, and 12 months.",[19],"Amputation",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},45,"ESTIMATED",[29,36,44],{"type":14,"name":30,"description":31,"armGroupLabels":32},"Questionnaire Administration","Ancillary studies",[33,34,35],"Arm 1 (targeted muscle reinnervation)","Arm 2 (regenerative peripheral nerve interface)","Arm 3 (TMI + RPNI)",{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"PROCEDURE","Regenerative Peripheral Nerve Interface Surgery","Undergo regenerative peripheral nerve interface surgery",[34,35],[42,43],"Regenerative Peripheral Nerve Interface","RPNI",{"type":37,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Targeted Muscle Reinnervation","Undergo targeted muscle reinnervation",[33,35],[49],"TMR",[51],{"measure":52,"description":53,"timeFrame":54},"Safety and Adverse Events (AEs)","Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0","Through study completion; an average of 1 year",[],"ALL","18 Years",null,false,{"inclusion":61,"exclusion":65,"raw_text":72},[62,63,64],"Patients greater than or equal to 18 years of age who are receiving an amputation for oncologic reasons","Patients with available mixed major nerves and donor motor nerves in the amputation stump or reconstructive tissue","Patients able to complete informed consent",[66,67,68,69,70,71],"Patients under 18 years of age","Patients unable to give consent","Patients receiving an amputation for non-oncologic purposes","Patients with amputations performed for immediate palliation (life expectancy less than 3 months), as this technique takes a minimum of 3-6 months for effect","Patients with multiple limb amputations","Patients receiving nerve management in a delayed fashion (patients who have previously received an amputation and present with neuroma)","Inclusion Criteria:\n\n* Patients greater than or equal to 18 years of age who are receiving an amputation for oncologic reasons\n* Patients with available mixed major nerves and donor motor nerves in the amputation stump or reconstructive tissue\n* Patients able to complete informed consent\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Patients unable to give consent\n* Patients receiving an amputation for non-oncologic purposes\n* Patients with amputations performed for immediate palliation (life expectancy less than 3 months), as this technique takes a minimum of 3-6 months for effect\n* Patients with multiple limb amputations\n* Patients receiving nerve management in a delayed fashion (patients who have previously received an amputation and present with neuroma)",[74,75],"ADULT","OLDER_ADULT",[77],{"facility":78,"status":8,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":91},"M D Anderson Cancer Center","Houston","Texas","77030","United States",[84,89],{"name":85,"role":86,"phone":87,"email":88},"Margaret S. Roubaud","CONTACT","713-794-1247","msroubaud@mdanderson.org",{"name":85,"role":90},"PRINCIPAL_INVESTIGATOR",{"lat":92,"lon":93},29.76328,-95.36327,[],[96],{"name":97,"affiliation":13,"role":90},"Margaret S Roubaud",[],[100],{"label":13,"url":101},"http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":103,"biomarkers":104},[19],[],{"nct_id":4,"found":15,"summary":106,"prompt_version":116},{"design":107,"status":108,"heading":109,"summary":110,"follow_up":111,"word_count":112,"commitments":113,"compensation":114,"drugs_mentioned":115},"This interventional study plans to enroll 45 participants. You would be randomly assigned to one of three groups: TMR alone, RPNI alone, or TMR combined with RPNI.","completed","Surgical Techniques for Phantom and Residual Limb Pain After Amputation","This study is looking at two surgical techniques, Targeted Muscle Reinnervation (TMR) and Regenerative Peripheral Nerve Interfaces (RPNI), to help cancer patients who have had an amputation and are experiencing chronic residual limb pain or phantom limb pain. These techniques involve connecting cut nerves to muscles to help them heal. Researchers want to see if using TMR, RPNI, or a combination of both is most effective in reducing pain. They will also look at how much pain medication you use and if you use a prosthetic limb. This study is for adults aged 18 and older who are having an amputation for cancer reasons and have suitable nerves for these procedures. The study aims to understand the safety and effectiveness of these treatments.","You would be followed for an average of 1 year to monitor safety and adverse events.",123,"You would undergo one of the surgical procedures and then have follow-up appointments at 3, 6, and 12 months after the surgery.","Not stated in the trial record.",[45],"v2"]