Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute

About this trial

The goal of this study is to evaluate the feasibility and preliminary efficacy of a combined acupuncture and exercise intervention for the management of chemotherapy-induced peripheral neuropathy (CIPN) in participants with bladder cancer receiving enfortumab vedotin (EV) and pembrolizumab (Pembro).

The names of the two study groups in this research study are:

* Acupuncture + Virtual Exercise (AVE) * Virtual Exercise Only (VE)

Eligibility criteria

Qualifiers

Age ≥ 18 years old

Diagnosed with pathologically proven urothelial cancer (UC)

Have received at least one cycle of EV-Pembro treatment with enrollment occurring after the 1st cycle and prior to the 4th cycle

Self-reported ability to walk for 6 minutes and/or 2 blocks

Disqualifiers

History of documented grade 2 or greater peripheral or motor neuropathy prior to EV-Pembro initiation; may confound assessment of the intervention's preventative effect

Patients with uncontrolled medical conditions that would preclude them from participating in moderate-to-vigorous intensity exercise in a virtual setting. Given the exercise environment is virtual, only patients with stable medical conditions should be enrolled to ensure their safety. Physical Activity Readiness Questionnaire (PARQ+) will be used during screening to facilitate conversations about present or historical medical conditions

Having continued grade 2 or higher adverse effects of their current treatment (EV-Pembro)

Receiving more than 10mg prednisone daily for any condition

Trial design

Treatments tested in this trial

  • Acupuncture
  • Exercise

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators