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

Phase

N/A

Condition

N/A

Treatment

Regenerative Peripheral Nerve Interface Surgery

Targeted Muscle Reinnervation

Questionnaire Administration

Clinical Study ID

NCT06840262

2019-0971

NCI-2021-08488

Ages > 18
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients greater than or equal to 18 years of age who are receiving an amputationfor oncologic reasons
Patients with available mixed major nerves and donor motor nerves in the amputationstump or reconstructive tissue
Patients able to complete informed consent

Exclusion

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 lessthan 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 havepreviously received an amputation and present with neuroma)

Study Design

Regenerative Peripheral Nerve Interface Surgery

August 10, 2020

February 02, 2027

Study Description

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.

Connect with a study center

M D Anderson Cancer Center
Houston, Texas 77030
United States
Active - Recruiting

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