M.D. Anderson Cancer Center
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.
Amputation
Questionnaire Administration
Regenerative Peripheral Nerve Interface Surgery
Targeted Muscle Reinnervation
NA
PRIMARY OBJECTIVE: Determine 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. SECONDARY OBJECTIVES: I. To estimate the rate and total quantity of any pain medication use among oncology amputees who received one of the three surgical techniques. II. 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. OUTLINE: Patients are randomized to 1 of 3 arms. ARM 1: Patients undergo TMR procedure. ARM 2: Patients undergo RPNI procedure. ARM 3: Patients undergo TMR in combination with RPNI. After completion of study procedure, patients are followed up at 3, 6, and 12 months.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 45 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | 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 |
| Actual Study Start Date : | 2020-08-10 |
| Estimated Primary Completion Date : | 2027-02-02 |
| Estimated Study Completion Date : | 2027-02-02 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
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RECRUITING
M D Anderson Cancer Center
Houston, Texas, United States, 77030