Trial Information

A Pilot Study to Evaluate a Nutritional Assessment Intervention to Improve Cancer-Related Fatigue Among Post-Allogeneic Blood and Marrow Transplantation Recipients

Recipients of an allogeneic BMT often experience fatigue as a side effect due to several
factors, including high-dose chemotherapy and/or radiation therapy as well as stress from
everyday activities that increase fatigue. In addition, after transplantation, the patient's
ability to maintain regular nutritional needs (usually due to the unique diet that is
required to help increase marrow function) is affected, which further increases fatigue
levels. Researchers want to use information learned in this study to find out if nutritional
intervention can help decrease fatigue levels and increase caloric intake.

Participating in this study involves routine visits to M. D. Anderson at the ambulatory
treatment center. Before you can start on this study, you will be asked about any allergies
you may have. You will also be asked some questions about your caregivers, such as how many
caregivers you have, whether your caregiver will be able to attend the nutrition class with
you, and whether the caregiver will record the food intake information. You will be asked
these questions to help the study researcher decide if you are eligible to take part in this
study. It should take about 30 minutes to collect this data. Your caregiver will be present
while this data is being collected. You will be asked to fill out questionnaires about your
medical history, personal demographics (such as your name, age, race, and gender), and
fatigue levels. These questionnaires should take about less than 1 hour to complete. The
study researcher will collect these questionnaires and put them in an envelope with a code
ID number on the front cover, instead of your name or other personal information.

A dietitian will then set-up an appointment (within 3 days after your first visit to the
ambulatory clinics) for a baseline test called indirect calorimetry. This test will be
performed in your treatment room in the ambulatory treatment clinic to find out how many
calories you need to have on a daily basis. For this test, you will be asked to sit quietly
in your treatment room and breathe through a mouth piece with a nose clip on your nose for
10 minutes. This test will use a machine to collect the air that you breathe in (inhalation)
and out (exhalation). The machine will use the information from your breathing to calculate
how many calories you will need to intake each day. This entire process should take about 1
hour to complete. You will be given recommended levels of dietary caloric intake and your
schedule for study activities within the first week of enrolling in this study. After this
test, you will be randomized (as in the toss of a coin) to a group.

There will be 2 groups in this study. There will be about 6 participants in each group. If
you are found to be eligible and you agree to take part in this study, you will be asked to
draw a sealed envelope from a bag, which will show which study group you will be in. You
will be allowed to draw only 1 envelope from the bag. You will have an equal chance of being
assigned to either group.

Participants in 1 group will be given standard care (for the next 42 days) for allogeneic
BMT at the ambulatory center. Participants in the other group will be given standard care
(for the next 45 days) for allogeneic BMT at the ambulatory center as well as nutritional
assessment and intervention. If your envelope has a label that says "standard," you will
receive standard care only. If your envelope has a label that says "intervention," you will
receive standard care as well as nutritional assessment and intervention.

During the first week on this study, you and your caregiver will receive training from the
dietitian about putting information in a food record, which will include your name and the
amount and kind of food and drink you intake from the time you get out of bed to the time
you go to bed. On Days 7, 21, and 35 (Weeks 1, 3, and 5), the study researcher will remind
you and your caregiver to start this food record and give you the recording sheets. You have
to turn in 3 daily food records for the specified weeks. If you have some days off from the
ambulatory center visits during that week, the study researcher would like you to complete a
one-day food record on your day off as part of the 3 daily records.

If you have a different caregiver on any one of the weeks, the dietitian will train the new
caregiver to record food and drinks on these days. The study researcher will collect the
food records and give you a fatigue questionnaire on Days 14, 28, and 42. It should take
about 30 minutes to complete. If you are not scheduled for a clinic visit on these specified
days, the study researcher will meet with you on the first visit following these dates.

If you are in the standard care group, you will receive an indirect calorimetry test at the
beginning of study, and you will submit 3-day food records every 2 weeks. You will not
receive the results from these food records. Your health care provider may refer you to see
a dietitian at any time during this study as part of your standard care. If at any time
your caloric intake is considered to be 50% or less of your expected intake, your regular
doctor will be notified.

If you are in the intervention group, the results from these food records will be given to
you by a dietitian within 3 days after the collection of food records (Days 17, 31, and 45).
You will receive these results in person with a dietitian consultant. You will be able to
discuss any issues related to food intake (such as food choices, food options, problems
related to meal preparation, and how to increase calories or nutrients) so that you might be
able to bring up the caloric intake to good level.

You will be taken off this study if you develop a condition called gastrointestinal graft
versus host disease, major organ failure (such as heart, kidney, or liver), or any
intolerable side effects from the standard care treatment you are on.

This is an investigational study. Up to 12 patients will take part in this pilot study. All
will be enrolled at M. D. Anderson.