Exercise and Nutrition Interventions for Chemotherapy-Induced Peripheral Neuropathy

Overseen By Javier Rosales, BS, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Maryland, Baltimore

Must not be taking: Taxanes, Bortezomib, Thalidomide

Disqualifiers: Regular exercise, Physical limitations, Surgery

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to ease chemotherapy-induced peripheral neuropathy (CIPN), a painful side effect causing tingling and numbness, common in patients receiving certain chemotherapy for gastrointestinal cancers. Participants will be randomly assigned to either an exercise program designed for cancer patients (EXCAP Exercise) or a nutrition education program. The trial aims to determine which approach might better reduce CIPN symptoms and improve quality of life. Ideal candidates are those with cancer who are about to start specific chemotherapy treatments and are not currently engaging in regular exercise. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in managing CIPN.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that exercise programs like the EXCAP Exercise program are generally safe for people receiving chemotherapy. Studies have found that simple home exercises, such as walking and resistance exercises, can reduce the severity and frequency of chemotherapy-induced peripheral neuropathy (CIPN). These exercises are usually well-tolerated by patients and don't cause major side effects.

For the nutrition education part, while direct safety data is limited, learning about healthy eating is considered low-risk. It involves understanding how to make better food choices, which is safe and beneficial for most people.

Overall, both the exercise and nutrition education parts of the program appear safe for participants. Research supports that the exercise program can be done safely at home without major problems. Nutrition education is low-risk and aims to improve diet during chemotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the EXCAP Exercise program because it offers a unique, non-drug approach to managing chemotherapy-induced peripheral neuropathy. Unlike typical treatments that primarily involve medications to relieve symptoms, EXCAP focuses on a progressive at-home walking and resistance exercise regimen tailored for cancer patients. This method not only targets physical symptoms but also aims to improve overall well-being and quality of life, potentially offering a holistic alternative to existing therapies. Additionally, the program's emphasis on patient empowerment and active participation could lead to better adherence and outcomes.

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

Research has shown that exercise can help reduce symptoms of nerve damage caused by chemotherapy, known as chemotherapy-induced peripheral neuropathy (CIPN). In this trial, participants may receive the EXCAP Exercise program, which studies have found can improve balance and quality of life for people with CIPN. Exercise has eased symptoms in patients receiving certain chemotherapy drugs, including those based on platinum. Another group in this trial will receive Nutrition Education, which is also under study, but current evidence is less clear about its effectiveness specifically for CIPN. While both exercise and nutrition are being researched in this trial, exercise appears more promising in reducing neuropathy symptoms. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with gastrointestinal cancer who are about to start or have recently started platinum chemotherapy (like oxaliplatin). They must be able to read English and not already doing regular exercise. People can't join if they have physical limitations, planned surgeries, brain-related cancers, or conditions that make MRI scans unsafe.

Inclusion Criteria

I have been diagnosed with cancer.

Be able to read English

I am scheduled for platinum chemotherapy without other nerve-damaging treatments.

Exclusion Criteria

Have contraindications for MRI scanning (pacemaker, ferrous metal implants, pregnancy, etc. note that most port-a-caths are safe for MRI scanning)

I am scheduled for surgery or radiation within the next 12 weeks.

I have or had cancer in my brain, brainstem, or spine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either exercise intervention or nutrition education to address chemotherapy-induced peripheral neuropathy

12 weeks

Regular visits for exercise or nutrition sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Follow-up assessments at 12 and 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EXCAP Exercise
• Nutrition Education

Trial Overview

The study compares the effects of an exercise program called EXCAP Exercise against Nutrition Education on chemotherapy-induced nerve pain and damage. It's a phase II trial aiming to understand how these interventions might reduce inflammation and improve body sensation.

How Is the Trial Designed?

Group I: EXCAP Exercise Experimental Treatment 1 Intervention

Exercise for Cancer Patients (EXCAP©®) involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program.

Group II: Nutrition Education Active Control 1 Intervention

Nutrition education involves equal time and attention as the exercise arm, but the content covers nutrition for cancer patients and lacks an exercise prescription.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

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 four-week home-based extremity exercise program for 13 breast cancer survivors showed significant improvements in self-reported symptoms of chemotherapy-induced peripheral neuropathy (CIPN) without any adverse events reported.

While the program was feasible and well-received by participants, it did not show significant changes in clinician-assessed CIPN, suggesting the need for larger studies and longer intervention periods to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extremity Exercise Program in Breast Cancer Survivors Suffering from Chemotherapy-Induced Peripheral Neuropathy: A Feasibility Pilot Study. Wu, CJ., Chan, YN., Yen, LY., 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]

Exercise significantly reduces the severity of chemotherapy-induced peripheral neuropathy (CIPN) symptoms and improves peripheral deep sensitivity, based on a meta-analysis of 13 studies.

Sensoriomotor training and mind-body exercises are particularly effective in alleviating CIPN symptoms, while active nerve-specific and mind-body exercises enhance peripheral deep sensitivity in cancer patients and survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise interventions to reduce chemotherapy-induced peripheral neuropathy severity: A meta-analysis. Nuñez de Arenas-Arroyo, S., Cavero-Redondo, I., Torres-Costoso, A., et al.[2023]

Exercise interventions significantly improve symptoms of chemotherapy-induced peripheral neuropathy (CIPN) in cancer patients, based on a meta-analysis of 178 participants from 5 studies.

Specific exercise protocols, including nerve gliding and sensorimotor-based exercises, were particularly effective in alleviating CIPN symptoms and improving postural stability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of exercise on chemotherapy-induced peripheral neuropathy symptoms in cancer patients: a systematic review and meta-analysis. Lin, WL., Wang, RH., Chou, FH., et al.[2021]

A randomized controlled trial with 40 participants showed that both sensorimotor training (SMT) and whole-body vibration training (WBV) significantly improved symptoms of chemotherapy-induced peripheral neuropathy (CIPN), including tendon reflexes and pain levels.

SMT demonstrated superior results in improving tendon reflexes and subjective symptom reports, while WBV was more effective in reducing pain, indicating that both exercise interventions are safe and feasible options for managing CIPN symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensorimotor training and whole-body vibration training have the potential to reduce motor and sensory symptoms of chemotherapy-induced peripheral neuropathy-a randomized controlled pilot trial. Streckmann, F., Lehmann, HC., Balke, M., et al.[2022]

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