Exercise for Neuropathic Pain from Chemotherapy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baltimore VA Medical Center

Disqualifiers: Diabetes, Coronary artery disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 36

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a serious healthcare concern. It is painful, persistent, resistant to conventional pain therapies, and results in long-term suffering and decreased quality of life for many cancer survivors. The role of exercise to decrease CIPN-related neuropathic pain (CIPN-NP) will be investigated, with the goal of identifying the mechanisms associated with this therapeutic approach to manage CIPN-NP.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of exercise as a treatment for neuropathic pain from chemotherapy?

Research suggests that exercise can help reduce neuropathic pain caused by chemotherapy. Studies in animals show that voluntary exercise can lessen pain and improve cell function in the brain. In humans, exercise has been linked to lower risk and reduced severity of neuropathic pain. ^{1 2 3 4 5}

Is exercise safe for humans undergoing chemotherapy?

Research suggests that exercise, including voluntary running and resistance exercises, is generally safe for humans undergoing chemotherapy. It has been studied in various clinical trials and shown to help with symptoms like neuropathic pain without causing harm. ^{2 4 5 6 7}

How does exercise differ from other treatments for chemotherapy-induced neuropathic pain?

Exercise is a unique treatment for chemotherapy-induced neuropathic pain because it is a non-drug approach that can reduce pain and improve cellular function in the brain. Unlike medications, which can be costly and have side effects, exercise is a low-cost option that can be tailored to individual needs and has been shown to help manage pain and improve quality of life. ^{1 2 3 4 8}

Research Team

Alice Ryan, PhD

Principal Investigator

University of Maryland at Baltimore School of Medicine

Eligibility Criteria

This trial is for cancer survivors aged 21-70 who finished chemotherapy between 6 months and a year ago, can walk on a treadmill, and have neuropathic pain from the treatment. They must not be regular exercisers or have other types of neuropathy.

Inclusion Criteria

Medical clearance from oncologist or primary care provider

Score on Neuropathic Pain Scale >1

My cancer is between stage I and IV.

Exclusion Criteria

Denial of CIPN

I have been diagnosed with coronary artery disease.

I have undergone more than one chemotherapy treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo aerobic or resistive training exercise interventions for 12 weeks, 3 times weekly with training on site

12 weeks

36 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• aerobic exercise intervention
• control group
• resistive training

Trial Overview The study looks at how aerobic exercise and resistive training might reduce nerve pain caused by chemotherapy. Participants will either join an exercise program or be in a control group to compare outcomes.

Participant Groups

Group I: resistive training Experimental Treatment 1 Intervention

Intervention is for 12 weeks 3 times weekly with training on site.

Group II: control Experimental Treatment 1 Intervention

This is an attention control group with regular contact by study staff.

Group III: aerobic exercise Experimental Treatment 1 Intervention

Aerobic exercise intervention is for 12 weeks 3 times weekly with training on site.

Who Is Running the Clinical Trial?

Baltimore VA Medical Center

Lead Sponsor

Trials

33

Recruited

3,000+

Findings from Research

Exercise has emerged as a promising intervention for chemotherapy-induced peripheral neuropathy (CIPN), which causes debilitating symptoms like tingling and pain in cancer patients, and has been investigated in around two dozen clinical trials.

Understanding the mechanisms and factors influencing the effectiveness of exercise for CIPN can help tailor exercise programs to individual patients, potentially improving their symptoms and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms, Mediators, and Moderators of the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy. Chung, KH., Park, SB., Streckmann, F., et al.[2022]

A systematic review of 8 randomized controlled trials involving 618 cancer patients found that physical exercise programs during chemotherapy can significantly improve quality of life and help prevent chemotherapy-induced peripheral neuropathy (CIPN).

The analysis showed a large effect size (g=0.83) favoring exercise over usual care, indicating that incorporating physical activity early in chemotherapy may be beneficial for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Physical Exercise Prevent Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer? A Systematic Review and Meta-analysis. Lopez-Garzon, M., Cantarero-Villanueva, I., Postigo-Martin, P., et al.[2022]

In a study of 355 cancer patients undergoing chemotherapy, a six-week exercise program significantly reduced symptoms of chemotherapy-induced peripheral neuropathy (CIPN), including hot/cold sensitivity and numbness/tingling in hands and feet.

The exercise intervention was particularly effective for older patients, males, and those with breast cancer, suggesting that exercise could be a beneficial non-drug treatment option for managing CIPN symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise during chemotherapy on chemotherapy-induced peripheral neuropathy: a multicenter, randomized controlled trial. Kleckner, IR., Kamen, C., Gewandter, JS., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized, single-blind, controlled, parallel assignment study of exercise versus education as adjuvant in the treatment of peripheral neuropathic pain. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Voluntary exercise reduces both chemotherapy-induced neuropathic nociception and deficits in hippocampal cellular proliferation in a mouse model of paclitaxel-induced peripheral neuropathy. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise and Neuropathic Pain: A General Overview of Preclinical and Clinical Research. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Mechanisms, Mediators, and Moderators of the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Can Physical Exercise Prevent Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer? A Systematic Review and Meta-analysis. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Effects of exercise during chemotherapy on chemotherapy-induced peripheral neuropathy: a multicenter, randomized controlled trial. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Effects of neuromuscular electrical stimulation combined with resistance exercises on muscle strength in adult hematological cancer patients: A randomized controlled study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Adjuvant physical exercise for the management of painful polyneuropathy. [2022]