Surgical techniques for treating pain after cancer-related amputations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Margaret S Roubaud — M.D. Anderson Cancer Center

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.