Chemotherapy-Induced Peripheral Neuropathy Survey

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01016028
Recruitment Status : Withdrawn (Study assessment tool development delayed.)
First Posted : November 18, 2009
Last Update Posted : May 3, 2016
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this research study is to learn more about pain and other symptoms that patients may experience while receiving chemotherapy treatment with platinum agents, taxanes, and/or bortezomib.

Condition or disease Intervention/treatment
Breast Cancer Colorectal Cancer Myeloma Chemotherapy-induced Peripheral Neuropathy Behavioral: Questionnaire Behavioral: Sensory Tests Behavioral: Interview

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Chemotherapy-Induced Peripheral Neuropathy: Feasibility and Validity of New Symptom Measurement Tools in Patients on Treatment With Platinum Agents, Taxanes and Bortezomib
Study Start Date : November 2009
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Questionnaire + Sensory Tests + Interview Behavioral: Questionnaire
3 questionnaires to collect information about any pain and/or symptoms experienced, general well-being, and personal information such as age and marital status. One (1) will be a symptom assessment questionnaire where asked to rate symptoms on a scale of 0-10.
Other Name: Survey

Behavioral: Sensory Tests
Test of sensitivity to things such as cold and touch, involve feeling cold objects, feeling bumps on a rectangular board, and putting pegs into holes on a board; and marking on computerized drawings areas experience pain, numbness, and/or cold sensitivity.

Behavioral: Interview
First 5 patients receiving platinum agents, taxanes, and bortezomib (15 patients total) will be asked to describe their symptoms in an open-ended, semi-structured 20-30 minute interview.

Primary Outcome Measures :
  1. Assessment of Patient's Symptoms (Questionnaire) [ Time Frame: Each patient administered questionnaire at single point in time. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients, age 18 years or older, receiving chemotherapy with cisplatin or oxaliplatin (platinum agents), taxanes, and/or bortezomib at UT MD Anderson Cancer Center.

Inclusion Criteria:

  1. Patients >= 18 years old.
  2. Patients must be fluent with the English language.
  3. Patients must be on chemotherapy regimes with any of the study drugs: cisplatin, oxaliplatin, taxanes and/or bortezomib.

Exclusion Criteria:

  1. Significant cognitive impairment as determined by the trained research staff
  2. Chronic alcoholism or substance abuse
  3. Diagnosis of severe depression

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01016028

Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Charles Cleeland, PHD,BA UT MD Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01016028     History of Changes
Other Study ID Numbers: 2009-0439
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: February 2013

Keywords provided by M.D. Anderson Cancer Center:
Colorectum Cancer
Colorectal disease
neuropathic symptom tool
chemotherapy-induced peripheral neuropathy
Quantitative Sensory Testing
symptom measurement tools
platinum agents

Additional relevant MeSH terms:
Colorectal Neoplasms
Peripheral Nervous System Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neuromuscular Diseases
Nervous System Diseases
Antineoplastic Agents