Trial Information

Acupuncture for Treatment of Uncontrolled Pain: A Feasibility Study

Acupuncture involves the insertion of small, solid, sterile needles into specific points on
the skin. The needles are placed in areas that are intended to help relieve pain.
Electrical stimulation is often applied to the needles to improve the treatment effects.
The procedure is designed to be comfortable and relaxing.

Acupuncture Sessions:

If you are found to be eligible to take part in this study, you will receive acupuncture
sessions 1-3 times per week in the acupuncture clinic at M. D. Anderson. The number of
sessions will depend on the type and location of the pain you may be experiencing.

For each session, you will be placed in a comfortable position and the study
doctor/acupuncturist will find points on your body and/or ears where the needles will be
placed. These points will be chosen based on the symptoms you are having at the time of
treatment, the location of the pain, and the type of pain.

Very thin, solid, sterile, stainless steel needles will be used. All of the needles are
specially made for acupuncture. The depth of the needle in the skin, the number of needles,
and whether the needles are near or far from the areas of pain will vary from person to
person, based on standard acupuncture procedures.

In most instances, needles placed on body points will remain in place for about 20-30
minutes. This length of time is the same for some points on the ears as well, but in some
instances, small gold or stainless steel needles may be placed on the ears. These needles
for the ears are designed to remain in place for 3-4 days. The ear needles are slightly
larger than the head of a pin and have a small ridge that is designed to help them remain in
place. If you prefer, a small flesh colored adhesive patch can be placed over the ear
needles as added protection. This is usually not necessary, but can be added if you prefer.

Electrical stimulation may be added to some of the needles, depending on the type of pain
you are experiencing and where it is located. This involves placing wires on the needles,
which are connected to a machine that delivers a mild electrical current through the wires.
The intensity (strength) of the electrical current will be adjusted gradually until it is at
a comfortable level for you.

Study Procedures:

At each session, before you receive the acupuncture, the following procedures will be
performed:

- Your vital signs will be measured.

- You will be asked about any medications you may be taking and any side effects you may
be experiencing.

- The color and coating of your tongue and the quality of your pulse will be recorded.

- If you are receiving medications that are known to affect your blood counts, blood
(about 1 teaspoon) will be drawn for routine tests to check your blood counts.

Each study visit will last about 1 hour. During the study, you may still receive your
regular pain treatments outside of this study.

Length of Study Participation:

You may receive up to 10 acupuncture sessions (depending on the location and type of pain).
If intolerable side effects or symptoms occur, you will be taken off study early.

End-of-Study Visit:

On the day of your last acupuncture session (called the end-of-study visit), or if you go
off study early for any reason, the following procedures will be performed:

Your medical history will be recorded. Your vital signs will be measured. You will be asked
about any medications you may be taking and any side effects you may have experienced.

You will complete the same 2 pain questionnaires as before. You will also complete a
questionnaire that has questions about your level of satisfaction with the acupuncture
services that were provided. In total, the 3 questionnaires should take about 15 minutes to
complete.

Your tongue and pulse will be evaluated.

Study Completion:

After the end-of-study visit, your participation in this study will be over.

This is an investigational study. The needles used in this study are FDA approved for use
in patients with cancer. It is considered experimental, however, to provide acupuncture
services to patients with cancer who have uncontrolled pain. Up to 64 patients will take
part in this study. All will be enrolled at M. D. Anderson.