We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Chemotherapy-Induced Peripheral Neuropathy Survey

This study has been withdrawn prior to enrollment.
(Study assessment tool development delayed.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01016028
First Posted: November 18, 2009
Last Update Posted: May 3, 2016
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.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
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 Intervention
Breast Cancer Colorectal Cancer Myeloma Chemotherapy-induced Peripheral Neuropathy Behavioral: Questionnaire Behavioral: Sensory Tests Behavioral: Interview

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

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

Enrollment: 0
Study Start Date: November 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01016028


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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01016028     History of Changes
Other Study ID Numbers: 2009-0439
First Submitted: November 17, 2009
First Posted: November 18, 2009
Last Update Posted: May 3, 2016
Last Verified: February 2013

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

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


To Top