Chemotherapy-Induced Peripheral Neuropathy Survey

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01016028
First received: November 17, 2009
Last updated: February 18, 2013
Last verified: February 2013
  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. ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2009
Estimated Primary Completion Date: January 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01016028     History of Changes
Other Study ID Numbers: 2009-0439
Study First Received: November 17, 2009
Last Updated: February 18, 2013
Health Authority: United States: Institutional Review Board

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:
Breast Neoplasms
Colorectal Neoplasms
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neuromuscular Diseases
Nervous System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014