Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy

Official title

Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy (ACE)

Overview

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 metastatic 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)

Detailed description

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 metastatic bladder cancer receiving enfortumab vedotin (EV) and pembrolizumab (Pembro).

CIPN is a side effect of some kinds of chemotherapy, and can lead to pain, numbness, tingling, swelling, or muscle weakness, primarily in the hands and feet and may persist for months or even years after chemotherapy ends.

Acupuncture involves using tiny needles to stimulate nerves and pathways in the body, and early research shows it might be helpful in reducing symptoms of CIPN.

Participants will be randomized in a 1:1 fashion into one of two study groups: AVE Arm: Acupuncture + Virtual Exercise or VE Arm: Virtual Exercise Only. Randomization means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, questionnaires, sensory tests, cycling test, and physical performance tests.

Participation in this research study is expected to last about 12 weeks.

About 50 people will take part in this study.

Interventions

• Procedure Acupuncture
  Acupuncture treatment with licensed acupuncturist.
• Behavioral Exercise
  Virtually supervised, technology-based aerobic and resistance exercise program. Exercise bike and resistance bands will be provided to participants. Exercise sessions will be via HIPAA-compliant, teleconference platform Zoom.

Primary outcome measures

• Neuropathic Pain Scale (NPS) Score Change from Baseline [Time frame: At 12 weeks]

Secondary outcome measures (10)

• Brief Pain Inventory-Short Form (BPI-SF) Score Change from Baseline [Time frame: Participants will complete BPI-SF survey at baseline, week 3, 6, 9 and 12.]
• Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-Ntx) Score Change from Baseline [Time frame: The FACT/GOG-Ntx will be completed at baseline, and weeks 3, 6, 9, and 12.]
• Chemotherapy-Induced Peripheral Neuropathy-20 (CIPN-20) Score Change from Baseline [Time frame: CIPN-20 will be completed as baseline, week 6 and 12.]
• Quantitative Sensory Testing (QST) Scores Change from Baseline [Time frame: QST will be completed at baseline and week 12 (PPT and CPM will be assessed at baseline only).]
• Relative Dose Intensity (RDI) [Time frame: RDI calculated at 12 weeks.]
• Treatment Delays Rate (TDR) [Time frame: Up to 12 weeks]
• Treatment Related Adverse Event (AE) Rate [Time frame: Up to 12 weeks]
• Early Discontinuation Rates (EDR) [Time frame: At 12 weeks]
• Weekly Exercise Session Completion Rates [Time frame: Assessed weekly during the 12-week intervention.]
• Program Retention Rate [Time frame: Assessed at 3, 6, and 12 weeks]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years old
• Diagnosed with pathologically proven advanced or metastatic urothelial cancer (mUC)
• Planning to receive treatment with EV-Pembro or have received up to two cycles of EV-Pembro treatment with enrollment occurring prior to the start of the third cycle
• Self-reported ability to walk for 6 minutes and/or 2 blocks
• Deemed acceptable for exercise by their treating provider
• Sedentary, currently engaging in less than or equal to 60 minutes of moderate or vigorous structured exercise/week, as assessed by the Godin Leisure-Time Exercise Questionnaire
• Willing to adhere to all study-related procedures, including randomization to one of the two possible acupuncture treatments
• Eligible per verbally administered Physical Activity Readiness Questionnaire (PAR-Q+)
• Referrals to physical therapy are allowed during the study if necessary; and
• Participants taking any of medications listed below must be on a stable regimen, with no changes in the past three months. Use of these medications may continue while on study.
• Duloxetine, amitriptyline, nortriptyline, gabapentin, and pregabalin

Exclusion criteria

• History of peripheral neuropathy prior to EV-Pembro initiation
• Patients with a pacemaker or other electronically charged medical device; or
• Participate in more than 60 minutes of moderate or vigorous structured exercise/week

Investigators will not include the following special populations:

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers < 18 years)
• Pregnant women
• Prisoners

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Dana Farber Cancer Institute — Boston

Identifiers

NCT: NCT07548476 · 25-454

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗