Chemotherapy-Induced Peripheral Neuropathy Survey
This study has been withdrawn prior to enrollment.
Sponsor:
M.D. Anderson Cancer Center
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
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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:
Genetics Home Reference related topics:
breast cancer
Charcot-Marie-Tooth disease
hereditary neuropathy with liability to pressure palsies
Drug Information available for:
Bortezomib
U.S. FDA Resources
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:
- Patients >= 18 years old.
- Patients must be fluent with the English language.
- Patients must be on chemotherapy regimes with any of the study drugs: cisplatin, oxaliplatin, taxanes and/or bortezomib.
Exclusion Criteria:
- Significant cognitive impairment as determined by the trained research staff
- Chronic alcoholism or substance abuse
- Diagnosis of severe depression
Contacts and Locations 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 May 19, 2013