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

ConditionAmputation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Regenerative Peripheral Nerve Interface Surgery

    Procedure/Surgery

    Undergo regenerative peripheral nerve interface surgery

  • Targeted Muscle Reinnervation

    Procedure/Surgery

    Undergo targeted muscle reinnervation

Treatment groups

54 Participants
are divided into 3 treatment groups
Group A: Arm 1 (targeted muscle reinnervation)Active comparator 2 interventions
Group B: Arm 2 (regenerative peripheral nerve interface)Active comparator 2 interventions
Group C: Arm 3 (TMI + RPNI)Experimental treatment 3 interventions

Trial outcomes

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

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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