Acupuncture and Exercise for Peripheral Neuropathy

(ACE Trial)

CD
Overseen ByChristina Dieli-Conwright, PhD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Dana-Farber Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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 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)

Who Is on the Research Team?

CD

Christina Dieli-Conwright, PhD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 years old or older.
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
See 7 more

Exclusion Criteria

Patients with a pacemaker or other electronically charged medical device
Participate in more than 60 minutes of moderate or vigorous structured exercise/week
I had nerve problems before starting EV-Pembro treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive acupuncture and/or virtual exercise sessions for the management of chemotherapy-induced peripheral neuropathy

12 weeks
3 exercise sessions per week, 1 acupuncture session per week (AVE arm)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Acupuncture
  • Exercise

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm AVE: Acupuncture + Virtual ExerciseExperimental Treatment2 Interventions
Group II: Arm VE: Virtual ExerciseActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials
1,128
Recruited
382,000+