Exercise + Nutrition Education for Peripheral Neuropathy

Recruiting at 1 trial location

Overseen By Po-Ju Lin, PhD, RD, MPH

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Rochester

Must be taking: Taxane chemotherapy

Must not be taking: Platinums, vinca alkaloids

Disqualifiers: Active exercisers, physical limitations, others

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

80 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 taxane chemotherapy, often used to treat breast cancer. 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.

Do I need to stop my current medications for the trial?

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 Exercise + Nutrition Education for Peripheral Neuropathy?

Research shows that exercise programs can improve symptoms and signs of peripheral neuropathy in people with diabetes, such as better balance and reduced neuropathic symptoms. Additionally, lifestyle interventions like exercise and education have been found to help manage peripheral neuropathy effectively. ^{1 2 3 4 5}

Is the combination of exercise and nutrition education safe for humans?

Research on exercise and nutrition education programs, even for conditions like diabetes, generally shows they are safe for humans. These programs often improve dietary habits and physical activity levels without significant safety concerns. ^{6 7 8 9 10}

How does the Exercise + Nutrition Education treatment differ from other treatments for peripheral neuropathy?

This treatment is unique because it combines exercise with nutrition education, focusing on lifestyle changes rather than medication. Unlike standard drug treatments, it aims to improve neuropathic symptoms by enhancing physical fitness and dietary habits, which can lead to better overall management of the condition. ^{1 2 3 4 11}

Eligibility Criteria

This trial is for women with breast cancer who are about to start taxane chemotherapy. They must be able to read English, be at least 18 years old, and have a life expectancy of at least six months. Participants should not already be active in exercise routines and must not have physical limitations that prevent them from exercising or MRI scans if applicable.

Inclusion Criteria

I am 18 years old or older.

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

I am female.

Exclusion Criteria

I do not have any conditions that prevent me from having an MRI scan.

You are not currently exercising regularly.

I have health issues that prevent me from doing intense exercise or walking programs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either exercise intervention or nutrition education during chemotherapy

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 25 weeks

Treatment Details

Interventions

• EXCAP Exercise
• Nutrition Education

Trial Overview The study compares the effects of an exercise program (EXCAP Exercise) versus nutrition education on chemotherapy-induced peripheral neuropathy (CIPN). It aims to understand how these interventions might influence inflammation and body awareness, helping design future studies.

Participant Groups

Group I: 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 Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A 12-week program of exercises for peripheral neuropathy (EPN) significantly reduced inflammatory markers TNF-α and CRP, and improved balance, pain, and tingling in women with diabetic neuropathy, compared to a control group.

Both EPN and low-intensity resistance training led to significant decreases in fasting blood glucose and HbA1c levels, indicating improved metabolic control in diabetic patients, while numbness showed no significant change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effect of two therapeutic exercises on the inflammatory and physiological conditions and complications of diabetic neuropathy in female patients. Nadi, M., Bambaeichi, E., Marandi, SM.[2022]

A 12-week integrated exercise program significantly improved glycemic control and peripheral sensation in patients with Type 2 diabetic peripheral neuropathy, as indicated by better results in various measures like HbA1c and sensory tests.

The exercise program included techniques like massage and foam rolling to enhance blood circulation and reduce pain, which likely facilitated the patients' ability to engage in aerobic and resistance exercises more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Exercise and Glycemic and Peripheral Sensation Control in Diabetic Neuropathy: A Single-Blind, Randomized Controlled Trial. Heidari, M., Zolaktaf, V., Ghasemi, G., et al.[2022]

A 12-week program combining training and Vitamin D supplementation significantly reduced symptoms of sensory-motor neuropathy, such as numbness, pain, tingling, and weakness in women with type II diabetes.

Participants also showed improved sensory functions, including touch, finger position detection, and vibration perception, indicating that this combined approach may enhance nerve function in diabetic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Comparison between Effects of 12 weeks Combined Training and Vitamin D Supplement on Improvement of Sensory-motor Neuropathy in type 2 Diabetic Women. Nadi, M., Marandi, SM., Esfarjani, F., et al.[2020]

An 8-week study involving 24 adults with diabetes and peripheral neuropathy showed that both exercise and education interventions significantly improved neuropathic signs and symptoms, as measured by the Michigan Neuropathy Screening Instrument and vibratory perception threshold.

While both interventions were effective, exercise appeared to have a slight edge in improving clinical signs and symptoms of neuropathy, suggesting that physical activity may be particularly beneficial in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Structured Exercise Compared with Education on Neuropathic Signs and Symptoms in People at Risk of Neuropathic Diabetic Foot Ulcers: A Randomized Clinical Trial. Perrin, BM., Southon, J., McCaig, J., et al.[2022]

Exercise therapy may provide short-term benefits in reducing neuropathic symptoms and improving physical function in people with diabetic neuropathy, based on a review of 11 randomized clinical trials involving 517 participants.

However, the overall quality of evidence supporting these benefits is very low, and no significant effects were observed on psychosocial aspects of health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise therapy on diabetic neuropathy: A systematic review and meta-analysis. Hernando-Garijo, I., Medrano-de-la-Fuente, R., Mingo-Gómez, MT., et al.[2023]

A scoping review of 170 studies highlighted the need for systematic reviews on behavior counseling or coaching from dietitians and exercise practitioners, as these interventions are crucial for improving nutrition and physical activity outcomes in adults, especially those with cardiometabolic risks.

The review found a significant amount of research on mobile applications and nutritional ergogenic aids, indicating that these tools are being actively studied, but there is a gap in synthesizing the effectiveness of personalized coaching interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition and physical activity interventions for the general population with and without cardiometabolic risk: a scoping review. Rozga, M., Jones, K., Robinson, J., et al.[2023]

A survey of 95 dietitians in Nova Scotia revealed that over half had no prior training in physical activity and exercise (PAE), and they infrequently prescribed exercise or made referrals, indicating a gap in practice despite moderate confidence in counseling.

There is a strong interest among dietitians for further education in PAE, along with a recognized need for community-based exercise programs and qualified professionals to whom they can refer patients, highlighting an opportunity for collaboration to enhance patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Counselling and Exercise Prescription Practices among Dietitians Across Nova Scotia. O'Brien, MW., Shields, CA., Dunbar, MJ., et al.[2022]

A 9-month study involving 33 patients with type 2 diabetes showed that a food education program combined with a supervised exercise regimen significantly improved dietary patterns, including increased intake of healthy fats and vegetables.

The program had a retention rate of 54%, highlighting the importance of strategies to enhance participant attendance and adherence for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a community-based food education programme on dietary pattern in patients with type 2 diabetes: Results of a pilot randomised controlled trial in Portugal. Vasconcelos, C., Cabral, M., Ramos, E., et al.[2021]

The nutrition education program significantly increased knowledge about diabetes management among 44 participants, with a p-value of less than 0.01, indicating strong statistical significance.

While there was no significant change in eating behavior overall, participants' food records showed that their intake of protein and fat was within the recommended limits set by the American Diabetes Association, suggesting some positive dietary adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A regional diabetes nutrition education program: its effect on knowledge and eating behavior. Pedersen, AL., Lowry, KR.[2017]

Medical nutrition therapy (MNT) is an effective approach for managing glycemia, lipids, and blood pressure in individuals with diabetes, as supported by the 2002 American Diabetes Association guidelines.

MNT should evolve from focusing on weight management to improving insulin resistance and metabolic control, especially as beta-cell function declines, necessitating a shift from dietary management alone to combinations with oral medications and insulin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based medical nutrition therapy for diabetes. Franz, MJ.[2017]

An 8-week exercise program focusing on hand, finger, and foot exercises significantly improved motor function and activities of daily living in patients with diabetic peripheral neuropathy, as shown by assessments like the Patient Neurotoxicity Questionnaire and various physical function tests.

The exercise group demonstrated notable enhancements in specific daily tasks, such as climbing stairs and performing chores, indicating that these exercises can effectively improve limb function in individuals suffering from diabetic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hand and foot exercises for diabetic peripheral neuropathy: A randomized controlled trial. Win, MMTM., Fukai, K., Nyunt, HH., et al.[2021]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison of the effect of two therapeutic exercises on the inflammatory and physiological conditions and complications of diabetic neuropathy in female patients. [2022]

2. Iran pubmed.ncbi.nlm.nih.gov

Integrated Exercise and Glycemic and Peripheral Sensation Control in Diabetic Neuropathy: A Single-Blind, Randomized Controlled Trial. [2022]

3. India pubmed.ncbi.nlm.nih.gov

The Comparison between Effects of 12 weeks Combined Training and Vitamin D Supplement on Improvement of Sensory-motor Neuropathy in type 2 Diabetic Women. [2020]

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

The Effect of Structured Exercise Compared with Education on Neuropathic Signs and Symptoms in People at Risk of Neuropathic Diabetic Foot Ulcers: A Randomized Clinical Trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effects of exercise therapy on diabetic neuropathy: A systematic review and meta-analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Nutrition and physical activity interventions for the general population with and without cardiometabolic risk: a scoping review. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Physical Activity Counselling and Exercise Prescription Practices among Dietitians Across Nova Scotia. [2022]

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

The impact of a community-based food education programme on dietary pattern in patients with type 2 diabetes: Results of a pilot randomised controlled trial in Portugal. [2021]

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

A regional diabetes nutrition education program: its effect on knowledge and eating behavior. [2017]

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

Evidence-based medical nutrition therapy for diabetes. [2017]

11. Australia pubmed.ncbi.nlm.nih.gov

Hand and foot exercises for diabetic peripheral neuropathy: A randomized controlled trial. [2021]