Massage for Chemotherapy Induced Peripheral Neuropathy (CIPN)

Peripheral neuropathy is one of the most common chemotherapy side effects affecting the
nerves. Each year, thousands of patients receive oxaliplatin-based and taxane-based
chemotherapy and more than 50% of these patients will have Chemotherapy Induced Peripheral
Neuropathy (CIPN). CIPN can cause painful or abnormal skin sensation (such as pins and
needles), numbness, and/or nerve damage that may affect movement.

Baseline Visit:

Participant has already had certain tests as part of participant's routine care that helped
show that participant was eligible to take part in this study. If participant agrees to take
part in this study, the following tests and procedures will be performed at participant's
first study visit:

- Participant's vital signs (blood pressure, heart rate, temperature, and breathing rate)
will be measured.

- Participant's medical history will be recorded.

- Participant will be asked about any drugs participant may be taking and any side effects
participant may be having.

- Participant will complete a pre-study questionnaire. This questionnaire will ask how
participant feels about massage to treat CIPN. This questionnaire should take about 5
minutes to complete.

- Participant will be asked basic demographic information. This questionnaire should take
about 5 minutes to complete.

- Participant will complete 5 questionnaires about any symptoms participant may have. The
questionnaires should take about 20-30 minutes to complete in total.

- Participant will perform leg function and balance tests. For these tests, participant
will complete tasks such as walking and standing on 1 leg. These tests should take about
20 minutes to complete. Women who are able to become pregnant must have a negative urine
pregnancy test. To take part in this study, the pregnancy test must be negative. The
pregnancy test is free of charge to participant.

- If participant has not had a blood draw recently, blood (about 1 tablespoon) will be
drawn for routine tests.

The study doctor will discuss the screening test results with participant. If the screening
tests show that participant is not eligible to take part in the study, participant will not
be enrolled. Other options will be discussed with participant.

Study Groups:

If participant is found to be eligible to take part in this study, participant will be
randomly assigned (as in the roll of a dice) to 1 of 4 groups. The location of the massage
and the massage schedule will vary by group. Participant will either have massages 3 times a
week for 4 weeks or 2 times a week for 6 weeks.

Massage Treatments (All Participants):

Participant's massage treatments will be given on an outpatient basis in private rooms. For
participant's massage, participant will either lie on a table or sit in a reclined chair. The
total time will be about 30 minutes, which includes positioning participant on the chair or
table.

Study Visits:

One (1) time every week:

- Participant's vital signs will be measured.

- Participant will be asked about any drugs participant may be taking and any side effects
participant may be having.

At Weeks 3, 6, and 10 (for Groups 2 & 4) and Weeks 2, 4, and 10 (for Groups 1 & 3):

- Participant will complete the same 5 questionnaires.

- Participant will perform leg function and balance tests.

Length of Study:

Participant may continue participation on this study for up to 10 weeks, as long as the study
doctor thinks it is participant's best interest. Participant's active participation in this
study will be over after participant has completed the follow-up visit.

Follow-Up Visit:

After participant completes participant's final massage treatment, the following tests and/or
procedures will be performed:

- Participant's vital signs will be measured.

- Participant's medical history will be recorded.

- Participant will be asked about any drugs participant may be taking and any side effects
participant may be having.

- Participant will complete the same 5 questionnaires.

- Participant will perform leg function and balance tests.

- Participant will complete a brief exit interview that will ask about questions such as
if participant thinks participant benefitted from the massage. This interview should
take about 10 minutes to complete.

- If participant has not had a blood draw recently, blood (about 1 tablespoon) will be
drawn for routine tests.

This is an investigational study. The use of massage treatments for chronic CIPN is
investigational.

Up to 90 participants will be enrolled in this study. All will take part at MD Anderson.

Inclusion Criteria:

1. All gastrointestinal malignancies where the patient received oxaliplatin for cancer
treatment or breast malignancies where patients have received docetaxel or paclitaxel
for cancer treatment.

2. Greater or equal to 6 months from last chemotherapy treatment.

3. Must understand and read English, sign a written informed consent, and follow protocol
requirements.

4. Age greater than or equal to 18 years

5. Must be willing to come to MD Anderson Main Campus (Texas Medical Center) for
intervention.

6. Lower extremity neuropathy per patient report attributable to oxaliplatin, docetaxel
or paclitaxel (neurotoxic chemotherapeutic agents) as determined by patient history of
neurotoxic agent administration and no history of other attributable causes such as
diabetic neuropathy.

7. Patient self-report neuropathy score greater than or equal to 3 on a 0 to 10 numeric
scale and/or Grade 2 or 3 neuropathy (according to the National Cancer Institute
Common Toxicity Criteria 4 point grading scale).

8. Within 2 weeks prior to study enrollment the patient must be on a stable dose of
medications for management of CIPN symptoms. For at least 2 weeks prior to enrollment
Stable dose is defined as: 1) No change in drug class; 2) Increases or decreases that
are less than or equal to 20% of the total dosage. All drug classes are allowed..

Exclusion Criteria:

1. Patients with previously diagnosed peripheral neuropathy pre -dating their neurotoxic
chemotherapy administration or from causes other than chemotherapy.

2. Platelets less than 50,000 or neutrophil count less than 500 within 6 months prior to
study enrollment.

3. Deep venous thrombosis (DVT) diagnosed within 12 months of study enrollment or history
or untreated lower extremity DVT, bone metastases, currently active skin infection, or
lymphedema currently involving the treatment field.

4. Women who are pregnant at time of enrollment. Pregnancy will be assessed at enrollment
using urine pregnancy test.

5. Diagnosis of diabetes