Heading Off Peripheral Neuropathy With Exercise

NCT00869804 | Terminated DMC

• 1 other identifier: 0478-08-FB
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Nervous System Disorders; Breast Neoplasms; Chemotherapy

Keywords

breast cancer; chemotherapy-induced peripheral neuropathy; exercise

Outcome Measures

Primary Outcomes (1)

• effect size for reduction of neuropathic symptoms

  effect size for reduction of neuropathic symptoms

  Baseline, 4, 8 12, 24 weeks

Secondary Outcomes (2)

• effect size for potential covariates on measures of chemotherapy-induced peripheral neuropathy

  Baseline, 4, 8, 12, 24 weeks

• feasibility and acceptability of a home-based aerobic and strength training exercise program

  Baseline, 4, 8, 12, 24 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

combination aerobic (walking) and resistance (strength training) exercise

Behavioral: Aerobic/ Resistance Exercise Intervention

attention control

SHAM COMPARATOR

attention control with daily journal and cancer-related education

Behavioral: Attention control

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.

Exercise

Attention control BEHAVIORAL

attention control

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Constance Visovsky, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: March 26, 2009
• Study Start: March 25, 2009
• Primary Completion: December 13, 2011
• Study Completion: December 13, 2011
• Last Updated: December 5, 2023

Record last verified: 2023-11

Locations

US (1)