Chemotherapy-Induced Peripheral Neuropathy Survey

NCT01016028 | Withdrawn

• 1 other identifier: 2009-0439
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Colorectal Cancer; Myeloma; Chemotherapy-induced Peripheral Neuropathy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Assessment of Patient's Symptoms (Questionnaire)

  Each patient administered questionnaire at single point in time.

Study Arms (1)

Questionnaire + Sensory Tests + Interview

Behavioral: Questionnaire; Behavioral: Sensory Tests; Behavioral: Interview

Interventions

Questionnaire BEHAVIORAL

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.

Also known as: Survey

Questionnaire + Sensory Tests + Interview

Sensory Tests BEHAVIORAL

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.

Questionnaire + Sensory Tests + Interview

Interview BEHAVIORAL

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.

Questionnaire + Sensory Tests + Interview

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Significant cognitive impairment as determined by the trained research staff
• Chronic alcoholism or substance abuse
• Diagnosis of severe depression

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Neoplasms, Plasma Cell; Neoplasms; Pain

Interventions

Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms by Histologic Type; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Charles Cleeland, PHD,BA

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2009
• First Posted: November 18, 2009
• Study Start: November 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 3, 2016

Record last verified: 2013-02