Clinical trial NCT01016028: Chemotherapy-Induced Peripheral Neuropathy Survey
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 type: OBSERVATIONAL
Overall status: WITHDRAWN
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2009-11-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Detailed description: If patient agrees to take part in this study, they will be asked to complete 3 questionnaires, 3 sensory tests, and may be asked to take part in a one-on-one symptom interview.

Symptom Interview:

Depending on when patient is enrolled in this study, they may take part in a one-on-one interview with a study staff member. A total of 15 participants will take part in this interview (5 taking platinum agents, 5 taking taxanes, \& 5 taking bortezomib). During the interview, patient will be asked to describe their symptoms. The interview should take about 20-30 minutes to complete.

The interviews will be digitally recorded, transcribed (typed), and used by researchers to identify symptoms related to receiving this type of chemotherapy. Researchers will use this information to design a study questionnaire that focuses on chemotherapy symptoms in the hands and feet. The digital recordings and typed copies of the interview will be destroyed after researchers have analyzed the interview data and the study is complete.

Questionnaires \& Sensory Tests:

All study participants will complete 3 questionnaires that are designed to collect information about any pain and/or symptoms patient may have experienced, their general well-being, and personal information such as age and marital status. One (1) of them is called a symptom assessment questionnaire and patient be will asked to rate their symptoms on a scale of 0-10.

All study participants will also complete 3 tests, called sensory tests, that are designed to help researchers learn how sensitive patient is to things such as cold and touch. These tests involve feeling cold objects, feeling bumps on a rectangular board, and putting pegs into holes on a board. Patient will also be asked to mark on computerized drawings the areas where they experience any pain, numbness, and/or cold sensitivity. A study staff member will explain how to take the tests and use the computerized drawings in more detail at the time these tests are performed.

It should take about 20-30 minutes to complete all of the questionnaires and tests.

Additional Sensory Testing:

Out of the 200 participants on this study, 40 participants will be asked to return to the clinic for additional sensory testing to help researchers learn if the tools used for this study are working as expected.

This additional testing is designed to help researchers learn how sensitive patient is to things such as touch, cold, warmth, and a pinprick to the finger, hand, or arm. Patient will be asked to describe how well they can feel each test, and how much pain they may or may not feel. This additional testing should take about 60 minutes to complete.

Length of Study:

After patient has completed the interview (if they are asked), 3 questionnaires, and 3 sensory tests their participation on this study will be over. If patient is selected to take part in the additional sensory testing, their participation on this study will be over after those tests are complete.

This is an investigational study.

Up to 200 participants will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility 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

Primary outcomes:
measure: Assessment of Patient's Symptoms (Questionnaire)
timeFrame: Each patient administered questionnaire at single point in time.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Charles Cleeland, PHD,BA
role: PRINCIPAL_INVESTIGATOR
References: