Exercise + Nutrition Education for Peripheral Neuropathy
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
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
Prior Safety Data
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.
12345Is 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.
678910How 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.
123411Eligibility 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.
+4 more
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.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: ExerciseExperimental Treatment1 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 EducationActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MarylandBaltimore, MD
University of Rochester Medical CenterRochester, NY
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Who Is Running the Clinical Trial?
University of RochesterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Comparison of the effect of two therapeutic exercises on the inflammatory and physiological conditions and complications of diabetic neuropathy in female patients. [2022]The purpose of this study was to compare the effect of 12 weeks of low-intensity resistance training and exercises for peripheral neuropathy (EPN) on the inflammatory and physiological conditions, balance, and complications of diabetic neuropathy in female patients.
Integrated Exercise and Glycemic and Peripheral Sensation Control in Diabetic Neuropathy: A Single-Blind, Randomized Controlled Trial. [2022]Neuropathy control and management is an objective in therapeutic exercises prescribed for patients with Type 2 diabetic peripheral neuropathy. We examined the effects of 12-week integrated exercise (IE) on glycemic control and peripheral sensation criteria in patients with diabetic neuropathy.
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]Peripheral neuropathy is a common complaint of diabetes. This study aimed to determine the effects of 12 weeks combined training with Vitamin D supplement on improvement of sensory-motor neuropathy in women with diabetic neuropathy.
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]Background and Objectives: Lifestyle interventions such as exercise prescription and education may play a role in the management of peripheral neuropathy in people with diabetes. The aim of this study was to determine the effect of undertaking an exercise program in comparison with an education program on the signs and symptoms of peripheral neuropathy in people with diabetes at risk of neuropathic foot ulceration. Materials and Methods: Twenty-four adult participants with diabetes and peripheral neuropathy were enrolled in this parallel-group, assessor blinded, randomised clinical trial. Participants were randomly allocated to one of two 8-week lifestyle interventions, exercise or education. The primary outcome measures were the two-part Michigan Neuropathy Screening Instrument (MNSI) and vibratory perception threshold (VPT). Secondary outcome measures included aerobic fitness, balance and lower limb muscular endurance. Results: Participants in both lifestyle interventions significantly improved over time for MNSI clinical signs (MD: -1.04, 95% CI: -1.68 to -0.40), MNSI symptoms (MD: -1.11, 95% CI: -1.89 to -0.33) and VPT (MD: -4.22, 95% CI: -8.04 to -0.40). Although the interaction effects did not reach significance, changes in values from pre to post intervention favoured exercise in comparison to control for MNSI clinical signs (MD -0.42, 95% CI -1.72 to 0.90), MNSI clinical symptoms (MD -0.38, 95% CI -1.96 to 1.2) and VPT (MD -4.22, 95% CI -12.09 to 3.65). Conclusions: Eight weeks of exercise training or lifestyle education can improve neuropathic signs and symptoms in people with diabetes and peripheral neuropathy. These findings support a role for lifestyle interventions in the management of peripheral neuropathy.
Effects of exercise therapy on diabetic neuropathy: A systematic review and meta-analysis. [2023]To evaluate the effects of exercise therapy on neuropathic symptoms, signs, psychosocial aspects, and physical function in people with diabetic neuropathy (DN).
Nutrition and physical activity interventions for the general population with and without cardiometabolic risk: a scoping review. [2023]The objective of this scoping review was to examine the research question: In the adults with or without cardiometabolic risk, what is the availability of literature examining interventions to improve or maintain nutrition and physical activity-related outcomes? Sub-topics included: (1) behaviour counseling or coaching from a dietitian/nutritionist or exercise practitioner, (2) mobile applications to improve nutrition and physical activity and (3) nutritional ergogenic aids.
Physical Activity Counselling and Exercise Prescription Practices among Dietitians Across Nova Scotia. [2022]The purpose of this study was to assess the perceptions and practices around physical activity counselling and exercise prescription of dietitians in Nova Scotia. Dietitians (n = 95) across Nova Scotia completed an online self-reflection survey regarding their current physical activity and exercise (PAE) practices. Most (51%; n = 48) reported no previous PAE educational training. Dietitians infrequently prescribed exercise to their patients (16% ± 26% of appointments) or provided PAE referrals (17% ± 24%). Dietitians reported moderate confidence (57% ± 21%) performing PAE counselling and included PAE-related content in half of patient appointments (52% ± 31%). Almost all respondents (95%) identified interest in further PAE education or training. Open-ended responses also demonstrated the need for community-based exercise programs (28% of providers) and qualified exercise professionals to refer to (25%). Overall, dietitians report rarely providing patients with written exercise prescriptions or referrals to other professionals for PAE content but do frequently include PAE in patient appointments. Dietitians in Nova Scotia are well positioned to promote PAE, but more educational training and improved referral systems to qualified exercise professionals or community exercise programs is strongly desired. Exercise professionals and dietitians should concurrently advocate for these changes and collaborate to help more patients lead physically active lifestyles.
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]The purpose of this study was to analyse the effects of a food education programme, with easy-to-implement strategies integrated in a community-based exercise programme, on dietary pattern of patients with type 2 diabetes (T2D). Thirty-three patients (65.4 ± 5.9 years old) were engaged in a 9-month randomised controlled trial: a supervised exercise programme (control group [CON]; n = 15; combined exercise; three sessions per week; 75 min per session) or the same exercise programme plus a concomitant 16-week food education programme (experimental group [EXP]; n = 18; 15-min. group classes and dual-task strategies during exercise). Dietary pattern was assessed using a 3-day food record at baseline and at 9 months. The intake of total fat, polyunsaturated fat, and the daily servings of vegetables significantly increased in EXP compared with the CON group. Retention and adherence to the programme were 54% and 49.5 ± 27.2%, respectively. This food education programme improved dietary pattern of patients with T2D. Special attention should be given to strategies that support participants' attendance.
A regional diabetes nutrition education program: its effect on knowledge and eating behavior. [2017]The effect of a nutrition education program on knowledge and self-care behavior in a group of individuals with diabetes was evaluated. The nutrition education program was developed using outlines and knowledge tests produced by the University of Michigan Diabetes Research and Training Center. The program, sponsored by the American Diabetes Association, Akron Chapter, was presented free of charge to Northeast Ohio area residents. Forty-four individuals participated in the study. Results indicated a statistically significant (p
Evidence-based medical nutrition therapy for diabetes. [2017]The 2002 American Diabetes Association (ADA) nutrition principles and recommendations are classified according to the level of evidence available using the ADA evidence grading system. Research also supports medical nutrition therapy (MNT) as an effective therapy in reaching treatment goals for glycemia, lipids, and blood pressure. Recommendations for carbohydrate, protein, dietary fat, micronutrients, and alcohol are summarized. The first priority for persons requiring insulin therapy is to identify a food/meal plan that can be used to integrate an insulin regimen into the person's lifestyle. MNT for type 2 diabetes progresses from prevention of obesity or weight gain to improving insulin resistance to contributing to improved metabolic control. The progressive decline in beta-cell failure requires that MNT progress from MNT as monotherapy to MNT in combination with oral glucose-lowering agents to MNT with insulin therapy. Monitoring of outcomes is essential to assess the outcomes of lifestyle interventions or to determine if changes in medication(s) are necessary.
Hand and foot exercises for diabetic peripheral neuropathy: A randomized controlled trial. [2021]Exercises for diabetic peripheral neuropathy remain controversial, especially with regard to recommended precautions and weightbearing exercises for individuals. We aimed to investigate the effect of 8 weeks of simple hand, finger, and foot exercises in patients with diabetic peripheral neuropathy. After randomization, exercise (n = 51) and control (n = 53) groups received usual care and diabetic foot care education; only the exercise group performed exercises. Primary outcomes, including activities of daily living (assessed using the Patient Neurotoxicity Questionnaire), neuropathy severity (monofilament and vibration test), and pain (behavioral rating scale and Visual Analog Scale), and secondary outcomes, including physical function of the hand and foot (grip, pinch, finger counting time, and Timed Up and Go tests), were assessed at baseline, after the 8-week intervention, and at the 16-week follow-up. The exercise group showed significantly stronger improvements in motor score and specific activities of daily living, such as climbing stairs and performing work or chores. Our exercises can be used to improve limb function in patients with diabetic neuropathy.