Trial Information

Lymphedema in Patients With Oral Cavity and Oropharyngeal Cancer: Prevalence, Functional Effects, and Treatment Outcomes

Screening for Part 1 of the Study:

The research staff will review your medical record to find out if you are possibly eligible
to join Part 1 of this study. You will be eligible if you have had radiation and/or surgery
(with or without chemotherapy) for mouth or throat cancer and it has been at least 1 month
since your last treatment.

Part 1 of the Study:

If you choose to participate in Part 1 of this study, you will complete questionnaires. The
questionnaires ask about your ability to swallow, eat, and speak, and about your quality of
life, your satisfaction with your body, and any head and neck cancer symptoms. In total,
the questionnaires should take less than 30 minutes to complete. You will also be asked
about any symptoms of lymphedema. Your answers will be compared to the answers of patients
who do and do not have lymphedema.

If you do not join Part 2 of this study, your participation in this study will be over after
you complete the questionnaires.

Screening for Part 2 of the Study:

If you have head and neck lymphedema, you may also be eligible for Part 2 of the study. You
will have "screening tests" to help the doctor decide if you are eligible for Part 2 of the
study:

- The answers you provide to a questionnaire during Part 1 of the study will help the
doctor find out if you may have lymphedema.

- Blood (about 1/2 teaspoon) will be drawn to check your thyroid function.

- Your doctor will also check your face and neck for signs of lymphedema during your
regular clinic visit.

The research staff will discuss the Part 2 screening test results with you, if applicable.
Signing this consent form does not mean that you will be able to participate in Part 2 of
this study. If the screening tests show that you are not eligible for Part 2, you will only
be enrolled in Part 1.

Part 2 of the Study:

If you are found to be eligible to take part in Part 2 of this study, you will first meet
with a certified lymphedema therapist in the Head and Neck Center. During this visit, the
therapist will perform a lymphedema exam. This involves checking your neck, face, and mouth
for swelling, and looking at your skin to check for any open wounds or infection. The
therapist will also interview you about how well you are able to swallow, eat, speak, and
perform other normal activities of daily living (performance status). This visit should
last about 1 hour.

All Part 2 participants will be offered CDT. It will be your choice if you would like to
receive a "full" CDT program or a "modified" CDT program. You may also choose to decline
both of these CDT options and stay on study for follow-up.

CDT has 4 steps that are designed to help the lymph fluids flow:

- Soft tissue of the face and neck is gently massaged, from inside or outside the mouth.
This lasts for about 30-45 minutes.

- Bandages are placed on the face and neck in order to apply gentle pressure to the
affected areas. The bandages stay in place for about 2-3 hours, before and/or after
the massage.

- The face and neck muscles are exercised a certain way for about 15 minutes or less,
while the bandages are in place.

- The face and neck is washed a certain way for about 5 minutes or less.

All 4 steps are done in both the full and modified CDT programs. The difference between the
full and modified programs is that the full program includes 10 CDT sessions at the clinic,
in addition to a self-managed CDT program at home. Otherwise, the 4 steps of CDT are the
same in both the clinic sessions and home sessions.

Full CDT Program:

If you choose to receive the full CDT program, you will come to the clinic and receive CDT
as described above, Monday through Friday for 2 weeks of intensive outpatient therapy. The
CDT will be done by the lymphedema therapist. Each session will last about 1 hour.

During your last 2 treatment visits (Visits 9 and 10), you will be taught how to do the CDT
steps at home. You will then perform the CDT steps at home, every day for the next 3
months.

Modified CDT Program:

If you choose to receive the modified CDT program, you will come to the clinic for 1-2
training sessions taught by the lymphedema therapist. Each training session will last about
1 hour, and you will be taught how to do the CDT steps at home. You will then perform the
CDT steps at home, every day for the next 3 months.

Option for No CDT:

If you decline both study treatment options, you will not receive CDT. You will stay on
study to receive follow-up as described below.

Follow-Up in Part 2 of the Study:

All Part 2 study participants will have 3 follow-up visits. If you received the full or
modified CDT program, the visits will be at 1, 3, and 6 months after your first lymphedema
training session. If you declined the CDT, the visits will be at 1, 3, and 6 months after
your study interview.

At these visits, you will complete the same questionnaires as you did for screening in Part
1 of the study. You will also have a lymphedema exam and interview by the lymphedema
therapist, like you did at the beginning of Part 2 of the study.

If you received the full or modified CDT program, a study staff member will also call you at
2, 6, and 9 weeks after your first lymphedema training session, to ask how the home CDT
program is going.

Length of Part 2:

If you are in Part 2, your participation in this study will be over after your 6-month
follow-up visit.

This is an investigational study. CDT is commonly used to treat all types of lymphedema,
including head and neck lymphedema. This study (Part 2) is designed to collect more data on
whether CDT can help to control head and neck lymphedema and its symptoms. Part 1 is also
designed to collect data related to head and neck lymphedema.

Up to 500 patients will take part in this study. All will be enrolled at M. D. Anderson.