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

Trial Summary

What is the purpose of this trial?

Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of platinum-based chemotherapy, often used to treat gastrointestinal cancers. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN, to systematically investigate the potential roles of inflammation and interoception, and to obtain data with a more accurate effect size to inform a future study.

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 the treatment for chemotherapy-induced peripheral neuropathy?

Research shows that exercise can help reduce the severity of chemotherapy-induced peripheral neuropathy (CIPN), which includes symptoms like tingling and numbness in hands and feet. Exercise has been studied in several clinical trials and is considered a promising intervention for managing these symptoms. ^{1 2 3 4 5}

Is exercise and nutrition intervention safe for humans?

Research suggests that exercise interventions are generally safe for cancer patients experiencing chemotherapy-induced peripheral neuropathy, as they have been studied in various trials without significant safety concerns. ^{1 2 3 4 6}

How does the EXCAP Exercise treatment differ from other treatments for chemotherapy-induced peripheral neuropathy?

EXCAP Exercise is unique because it uses physical activity to help manage symptoms of chemotherapy-induced peripheral neuropathy (CIPN), unlike traditional treatments that may focus on medication. Exercise has shown promise in improving symptoms like tingling, numbness, and pain by potentially enhancing nerve function and reducing inflammation, offering a non-drug alternative for patients. ^{1 2 4 5 7}

Eligibility Criteria

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 am 18 years old or older.

I have been diagnosed with cancer.

Be able to read English

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. 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]

2. Denmark pubmed.ncbi.nlm.nih.gov

Effects of exercise interventions to reduce chemotherapy-induced peripheral neuropathy severity: A meta-analysis. [2023]

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

Extremity Exercise Program in Breast Cancer Survivors Suffering from Chemotherapy-Induced Peripheral Neuropathy: A Feasibility Pilot Study. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

The effects of exercise on chemotherapy-induced peripheral neuropathy symptoms in cancer patients: a systematic review and meta-analysis. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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