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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?

This trial explores how acupuncture combined with virtual exercise can help manage chemotherapy-induced peripheral neuropathy (numbness and pain in hands or feet) in individuals with metastatic bladder cancer. Researchers compare two groups: one receiving both acupuncture and virtual exercise, and another receiving only virtual exercise. The trial targets those with advanced bladder cancer undergoing specific chemotherapy treatments who can walk short distances but engage in less than an hour of structured exercise each week. As an unphased trial, it offers a unique opportunity to explore innovative treatments that could improve quality of life.

Will I have to stop taking my current medications?

If you are taking duloxetine, amitriptyline, nortriptyline, gabapentin, or pregabalin, you can continue using them as long as your dosage has been stable for the past three months.

What prior data suggests that this acupuncture and exercise intervention is safe for managing chemotherapy-induced peripheral neuropathy?

Research has shown that acupuncture is generally safe for people with peripheral neuropathy, including those whose condition results from chemotherapy. Studies have found that acupuncture can improve symptoms without noticeable side effects. Some research even suggests it might be more effective than other treatments, such as medication or sham acupuncture.

Exercise is also widely recommended for many health issues and is usually well-tolerated. It can enhance strength, balance, and overall well-being, with no major safety concerns, especially when guided by a certified trainer.

Overall, both acupuncture and exercise appear to be safe options for managing peripheral neuropathy.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for peripheral neuropathy because they offer a novel approach by combining acupuncture with virtual exercise. Unlike standard treatments, which often rely on medications to manage symptoms, acupuncture provides a non-pharmacological option that may help improve nerve function and reduce pain. Additionally, the integration of virtual exercise sessions allows for greater accessibility and convenience, making it easier for patients to maintain an active lifestyle, which is crucial for managing neuropathy symptoms. Together, these treatments might enhance patient outcomes by addressing both physical and neurological aspects of the condition in a holistic manner.

What evidence suggests that this trial's treatments could be effective for chemotherapy-induced peripheral neuropathy?

Research has shown that acupuncture might help lessen the pain and numbness caused by peripheral neuropathy. Studies have found that acupuncture can improve nerve function and boost blood flow, sometimes more effectively than certain medications. For chemotherapy-induced nerve damage, acupuncture appears very promising, especially when tailored to each individual. In this trial, one group of participants will receive both acupuncture and virtual exercise sessions, while another group will participate in virtual exercise sessions alone. Exercise is known to improve nerve function and ease neuropathy symptoms. Combining acupuncture with exercise might provide more relief than exercise alone.26789

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?

This trial is for adults with advanced or metastatic bladder cancer who are about to start, or have just started (within two cycles), treatment with EV-Pembro and now have nerve damage from it. Participants must be mostly inactive, able to walk short distances, cleared for exercise by their doctor, and not have a pacemaker or prior neuropathy before starting EV-Pembro.

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

Trial Overview

The study compares two groups: one receives both acupuncture and virtual exercise sessions; the other gets only virtual exercise. The goal is to see if adding acupuncture helps manage chemotherapy-related nerve damage better than exercise alone.

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+

Citations

Acupuncture for neuropathic pain: A meta-analysis of ... - PMC

According to the results of the subgroup analysis, acupuncture had higher effectiveness than sham acupuncture or blank control for changes in pain intensity.

The efficacy of acupuncture for diabetic peripheral ...

Acupuncture showed better results than neurotrophic agents in improving circulation and significantly reducing clinical symptoms in patients with diabetic ...

The Effectiveness and Cost-effectiveness of Acupuncture in ...

The purpose of this study is to determine whether a course of acupuncture is effective in the management of peripheral neuropathy related pain in patients ...

Acupuncture for the Treatment of Peripheral Neuropathy - PMC

Acupuncture appears to improve nerve conduction study parameters in both sensory and motor nerves. Meta-analyses were conducted on all diabetic neuropathy and ...

Is acupuncture effective in treating peripheral neuropathy?

In the acupuncture group compared with the control group, 16 versus 7 cases were markedly relieved, 12 versus 14 cases improved, and 4 versus 12 cases failed, ...

Efficacy and safety of acupuncture for painful diabetic ... - PMC

Acupuncture demonstrates significant effectiveness in improving PDN outcomes, including Total effective rate, Pain intensity, MCV, SCV, Depression score, TCSS, ...

Network meta-analysis for comparative effectiveness and ...

Studies have shown that acupuncture reduces peripheral neuropathy symptoms in people with diabetes, CIPN, and human immunodeficiency virus [19]. Furthermore, ...

Effectiveness of Electroacupuncture in the Treatment ...

The indexes of secondary outcome evaluation are: 1) Overall clinical effectiveness rate; 2) TCSS score; 3) Chinese medicine symptom score; 4) patient's global ...

a systematic review and meta-analysis

Acupuncture may be effective and safe in the treatment of CIPN according to the analyzed studies. However, more studies with higher methodological quality are ...