---
title: Heading Off Peripheral Neuropathy With Exercise
nct_id: NCT00869804
overall_status: TERMINATED
phase: NA
sponsor: University of Nebraska
study_type: INTERVENTIONAL
primary_condition: Peripheral Nervous System Disorders
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00869804.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00869804"
ct_last_update_post_date: 2023-12-05
last_seen_at: "2026-05-12T06:40:57.513Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Heading Off Peripheral Neuropathy With Exercise

**Official Title:** Pilot Randomized Study of Aerobic and Resistance Exercise for Women Undergoing Treatment for Breast Cancer With Taxanes.

**NCT ID:** [NCT00869804](https://clinicaltrials.gov/study/NCT00869804)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Could not recruit total numbers needed. PI left institution.
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 19
- **Lead Sponsor:** University of Nebraska
- **Conditions:** Peripheral Nervous System Disorders, Breast Neoplasms, Chemotherapy
- **Start Date:** 2009-03-25
- **Completion Date:** 2011-12-13
- **CT.gov Last Update:** 2023-12-05

## Brief Summary

Chemotherapy for the treatment of breast cancer can affect nerves and muscles leading to loss of sensation in the hands and feet for feeling hot and cold, difficulty walking, and muscle weakness. This study will explore if exercises such as walking and strength training may prove helpful in preventing or lessening chemotherapy-induced peripheral neuropathy from chemotherapy, making the therapy easier to tolerate and increasing overall quality of life.

## Detailed Description

This pilot study will test the effects of a tailored home-based walking (aerobic) and strength training (resistance) exercise program for individuals receiving taxane-based chemotherapy for breast cancer on neuropathy, breast cancer-related symptoms, cold thermal sensation, vibratory sensation, gait \& balance, upper and lower extremity muscle strength, and quality of life.

The objective of this pilot study is to determine the effect size, feasibility and acceptability of a 12-week combination exercise program consisting of aerobic exercise (walking) and strength training for preventing or ameliorating the clinical manifestations and symptoms of CIPN in individuals with Stage I-IIIa non-metastatic breast cancer.

## Eligibility

- **Minimum age:** 19 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* age 19 or older with newly diagnosed Stage I-IIIa invasive breast cancer who are to be treated with a taxane-based chemotherapy regimen (with paclitaxel or docetaxel) and thus are at risk for the development of CIPN.

Exclusion Criteria:

* any disease (e.g. diabetes, HIV) that results in peripheral neuropathy;
* any disease or disorder that results in muscle weakness (such as chronic fatigue syndrome, multiple sclerosis, spinal cord tumors or injuries, stroke, preexisting cardiopulmonary disease);
* any disease or disorder that would preclude strength training exercises (such as bone metastasis, osteoporosis);
* individuals with diagnosed lymphedema or advanced disease (\> Stage IIIa, or metastatic disease) at high risk for bone metastases and pathologic fracture will be excluded.
```

## Arms

- **Exercise** (EXPERIMENTAL) — combination aerobic (walking) and resistance (strength training) exercise
- **attention control** (SHAM_COMPARATOR) — attention control with daily journal and cancer-related education

## Interventions

- **Aerobic/ Resistance Exercise Intervention** (BEHAVIORAL) — The intervention will consist of a tailored home-based program of both aerobic (walking, using pedometer) and strength training exercises for upper and lower extremities using resistance power bands.
- **Attention control** (BEHAVIORAL)

## Primary Outcomes

- **effect size for reduction of neuropathic symptoms** _(time frame: Baseline, 4, 8 12, 24 weeks)_ — effect size for reduction of neuropathic symptoms

## Secondary Outcomes

- **effect size for potential covariates on measures of chemotherapy-induced peripheral neuropathy** _(time frame: Baseline, 4, 8, 12, 24 weeks)_
- **feasibility and acceptability of a home-based aerobic and strength training exercise program** _(time frame: Baseline, 4, 8, 12, 24 weeks)_

## Locations (1)

- University of Nebraska Medical Center, Omaha, Nebraska, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of nebraska medical center|omaha|nebraska|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00869804.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00869804*  
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