Trial Information

Chemotherapy-Induced Peripheral Neuropathy: Feasibility and Validity of New Symptom Measurement Tools in Patients on Treatment With Platinum Agents, Taxanes and Bortezomib

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.