Surgical techniques for treating pain after cancer-related amputations
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
NA · M.D. Anderson Cancer Center · NCT06840262
This study is testing two different surgical methods to see if they can help cancer patients who have had amputations feel less pain in their residual limbs and reduce phantom limb pain.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06840262 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two surgical techniques, targeted muscle re-innervation (TMR) and regenerative peripheral nerve interfaces (RPNI), both alone and in combination, to alleviate chronic residual limb and phantom limb pain in cancer patients who have undergone amputation. The study aims to determine the relative effectiveness of these techniques using validated pain assessment scales and to estimate pain medication use and prosthetic use among participants. Patients will be randomized into three groups to receive one of the surgical interventions, followed by follow-up assessments at 3, 6, and 12 months post-procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing an amputation for oncologic reasons and have suitable nerve structures for the surgical techniques.
Not a fit: Patients who are under 18, unable to provide consent, or receiving amputations for non-oncologic reasons may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce chronic pain and improve quality of life for cancer patients who have undergone amputations.
How similar studies have performed: While the techniques of TMR and RPNI are established, the combination approach being evaluated in this trial is relatively novel and has not been extensively tested in this specific patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Margaret S Roubaud — M.D. Anderson Cancer Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Amputation