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A Pilot Study of a Strength and Balance Training Program for Persons With Oxaliplatin Induced Peripheral Neuropathy


N/A
18 Years
N/A
Open (Enrolling)
Both
Neuropathy, Gastrointestinal Cancer

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Trial Information

A Pilot Study of a Strength and Balance Training Program for Persons With Oxaliplatin Induced Peripheral Neuropathy


Inclusion Criteria:



- Prior history of colon cancer

- Completed oxaliplatin based chemotherapy at least 6 months prior to enrollment

- Report numbness, tingling, or pain of the lower extremities ≥ 4 by chemotherapy
induced peripheral neuropathy (CIPN) Visual Analog Rating

- Karnofsky performance status of at least 60%

- Able to read, write, and understand English

Exclusion Criteria:

- Patients will be excluded from the study if they live outside of a 30 mile radius of
the University of South Florida, if they are currently undergoing chemotherapy or
radiation therapy, or if they regularly (at least once a week) participate in
strength or balance training exercises. The investigators will not exclude
participants if they are participating in aerobic exercise, but we will collect that
information so that the investigators may control for aerobic exercise in our data
analysis.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Number of Screened Patients Who Participate and Complete the Study

Outcome Description:

To evaluate feasibility, the percentage of patients screened to percentage enrolled in the study and the percentage enrolled to percentage that completes the study will be calculated. Patients who do not complete the study will be contacted to determine why they were unable to complete the study and the reasons will be recorded. How many sessions were attended will also be recorded.

Outcome Time Frame:

10 Months

Safety Issue:

No

Principal Investigator

Cindy Tofthagen, Ph.D., ARNP

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of South Florida

Authority:

United States: Institutional Review Board

Study ID:

MCC-16557

NCT ID:

NCT01422993

Start Date:

July 2011

Completion Date:

September 2013

Related Keywords:

  • Neuropathy
  • Gastrointestinal Cancer
  • Oxaliplatin Induced
  • Peripheral Neuropathy
  • Strength
  • Balance
  • Training Program
  • Colon
  • Rectal
  • Peripheral Nervous System Diseases
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations
  • Neurotoxicity Syndromes
  • Gastrointestinal Neoplasms

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612