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

NCT06840262 | Recruiting DMC

• 2 other identifiers: 2019-0971NCI-2021-08488
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amputation

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (3)

Arm 1 (targeted muscle reinnervation)

ACTIVE COMPARATOR

Patients undergo TMR procedure.

Other: Questionnaire Administration; Procedure: Targeted Muscle Reinnervation

Arm 2 (regenerative peripheral nerve interface)

ACTIVE COMPARATOR

Patients undergo RPNI procedure.

Other: Questionnaire Administration; Procedure: Regenerative Peripheral Nerve Interface Surgery

Arm 3 (TMI + RPNI)

EXPERIMENTAL

Patients undergo TMR in combination with RPNI.

Other: Questionnaire Administration; Procedure: Regenerative Peripheral Nerve Interface Surgery; Procedure: Targeted Muscle Reinnervation

Interventions

Questionnaire Administration OTHER

Ancillary studies

Arm 1 (targeted muscle reinnervation); Arm 2 (regenerative peripheral nerve interface); Arm 3 (TMI + RPNI)

Regenerative Peripheral Nerve Interface Surgery PROCEDURE

Undergo regenerative peripheral nerve interface surgery

Also known as: Regenerative Peripheral Nerve Interface, RPNI

Arm 2 (regenerative peripheral nerve interface); Arm 3 (TMI + RPNI)

Targeted Muscle Reinnervation PROCEDURE

Undergo targeted muscle reinnervation

Also known as: TMR

Arm 1 (targeted muscle reinnervation); Arm 3 (TMI + RPNI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M.D. Anderson Cancer Center

Study Officials

• Margaret S Roubaud

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: August 10, 2020
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-09

Locations

US (1)