Trial Information

Parenteral Hydration in Advanced Cancer Patients - A Randomized Controlled Trial

For Caregivers:

Symptoms of dehydration may include fatigue, muscle contractions, the need for sedation
(calming medication), and hallucinations (where something is sensed that is not actually
there). Hydration allows the body to get rid of the waste products from medications and
other chemicals. When the fluid levels in the body are increased, the brain function may
directly improve.

If the patient under your care is found to be eligible to take part in this study, he or she
will be randomly assigned (as in the toss of the coin) to one of 2 groups. Participants in
Group 1 will receive normal saline (salt water) once a day. Participants in Group 2 will
receive a lower amount of normal saline once a day. This lower amount is small enough to be
considered a placebo. Doctors call something a placebo if it looks like the substance being
tested but has no active ingredients (or in this case, few active ingredients).

Both you and the patient will be asked to complete a number of questionnaires at the
beginning of the study, on Days 1-7, and then every 3-5 days after that. Your
questionnaires will ask about the feelings you may have about hydration and the care that
you are providing to the patient. Each day's questionnaires will take about 30 minutes.

Both you and the patient will also be interviewed by researchers at the beginning of the
study and on Day 4 (+/- 2 days). The interviews will include questions about what it has
been like for the patient to get fluids, whether the fluid was more like food or medicine,
whether the patient has ever gotten dehydrated, and how you manage the patient's care. The
interviews should each take about 30 minutes. The interviews in this study will be audio
taped so the information can be studied by researchers. Only the research staff will listen
to the audio tape of the interviews.

If the patient goes off study, your participation in the study will be over.

This is an investigational study. Up to 150 patients and 150 caregivers will take part in
this study. All will be enrolled at M. D. Anderson.

For Patients:

Before you can start treatment on this study, you will have "screening tests." These tests
will help the doctor decide if you are eligible to take part in this study. You will be
asked to complete a questionnaire. It will ask questions about your cancer diagnoses, the
medications you are taking, and the symptoms you are having. The questionnaire also asks
about your memory of being dehydrated, what it was like for you to get fluids, how you
manage your care, and whether the fluid was more like food or medicine. It should take
about 30 minutes to complete.

Both you and your caregiver will also be interviewed by researchers. There will be
questions about what it has been like for you to get fluids, whether the fluid was more like
food or medicine, and whether you have ever gotten dehydrated. Each interview should take
about 30 minutes. The interviews in this study will be audio taped so the information can
be studied by researchers.

The study staff will also check you for symptoms of muscle contraction, one of the signs of
dehydration. The study staff will videotape your face, arms, hands, legs and toes for a
total 3-5 minutes on Days 1, 4, and 7, and then every 3-5 days after that.

As part of the screening tests, you will also have blood drawn (about 2 teaspoons) for
routine tests. You will be asked questions about your ability to perform daily activities
(performance status evaluation). You will be asked about any side effects you may have,
including muscle contractions. You will also be asked to list any pain medications or other
medications that you take.

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the toss of the coin) to one of two groups. Participants in Group 1 will receive
normal saline (salt water) once a day. Participants in Group 2 will receive a lower amount
of normal saline once a day. This lower amount is small enough to be considered a placebo.
Doctors call something a placebo if it looks like the substance being tested but has no
active ingredients (or in this case, few active ingredients). You will have an equal chance
of being placed in either group. Neither you nor any of the medical staff or researchers on
this study will know which dose you are receiving.

The research nurse will ask you to complete several questionnaires that ask questions about
dehydration and the symptoms you may have experienced, including fatigue. The
questionnaires will be completed on Days 1-7, and then every 3-5 days after that. In total,
each day's questionnaires should take about 30 minutes. Your caregiver will also be asked
about his or her memory of your dehydration. On Day 7, you will have blood drawn (about 2
teaspoons) for routine tests.

Both you and your caregiver will also be interviewed by researchers on Day 4 (+/- 2 days),
and then every 3-5 days after that. The interviews will be like the ones at screening.

Starting on Day 1 of the study, you will receive saline through a catheter in a vein (over 4
hours) every day. If you already have a central venous catheter, you will receive the
saline through that catheter. If you do not have a central venous catheter, the saline will
be infused under the skin. Either way, the infusion will last about 4 hours.

During each infusion, an infusion research nurse will check to make sure that the saline is
given properly. This nurse will know which treatment group you have been assigned to.

Every day, the research nurse will ask you about the dehydration and any side effects you
may have. Every day, the research nurse will also check the place where the infusion is
given to make sure there is no infection.

On Days 1-7 and then every 3-5 days, the research nurse will also check for any dehydration
symptoms including the need for sedation, any restless feelings or actions, and/or muscle
contractions. You will have a performance status evaluation daily. On Days 1-7, the
research nurse will ask about any pain medications or other medications that you have taken.

Every day, 2 hours [+/- 3 hours] after the infusion ends, you will also be checked by an
assessment research nurse who will not know which treatment group you are in. The
assessment research nurse will ask about any symptoms you may have. The study staff will
also check you for symptoms of muscle contraction, one of the signs of dehydration. The
study staff will videotape your face, arms, hands, legs and toes for a total 3-5 minutes on
Days 1, 4, and 7, and then every 3-5 days after that.

You may remain on study to receive the daily infusions for as long as you are benefitting up
to Day 14 [+/- 3 days]. On Day 14 [+/- 3 days] you will be taken off study, and you will
have off study assessments, which include questions about your symptoms including fatigue,
performance status, medications you are taking, and dehydration symptoms. If intolerable
side effects occur, you will be taken off study and given appropriate medical care. If you
wish to continue receiving hydration fluids after you are taken off study [Day 14 +/- 3
days], you may discuss this option with your attending hospice physician. You may receive a
liter of normal saline each day under the skin. Treatment will be given by hospice nurse.
Fluid will be provided to you free of charge.

This is an investigational study. Up to 150 patients and 150 caregivers will take part in
this study. All will be enrolled at M. D. Anderson.