RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2020-08-10
Study Completion:2027-02-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06840262

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients greater than or equal to 18 years of age who are receiving an amputation for oncologic reasons
  2. * Patients with available mixed major nerves and donor motor nerves in the amputation stump or reconstructive tissue
  3. * Patients able to complete informed consent
  1. * Patients under 18 years of age
  2. * Patients unable to give consent
  3. * Patients receiving an amputation for non-oncologic purposes
  4. * 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
  5. * Patients with multiple limb amputations
  6. * Patients receiving nerve management in a delayed fashion (patients who have previously received an amputation and present with neuroma)

Contacts and Locations

Principal Investigator

Margaret S Roubaud
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Margaret S Roubaud, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-10
Study Completion Date2027-02-02

Study Record Updates

Study Start Date2020-08-10
Study Completion Date2027-02-02

Terms related to this study

Additional Relevant MeSH Terms

  • Amputation