Parenteral Hydration in Advanced Cancer Patients

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.

Inclusion Criteria:

1. Patients with advanced cancer (local recurrence or metastatic disease) admitted to
hospice care

2. Patients have reduced oral intake of fluids, as determined by clinical assessment.

3. Patients exhibit evidence of mild or moderate dehydration as defined by decreased
skin turgor in subclavicular region (more than 2 seconds), plus a score of >/= 2/5 in
the clinical dehydration assessment

4. In addition to fatigue, (expected to be present in all patients based on our pilot
study), patients must score >/= 1 on a 0 to 10 scale (0=no symptom, 10= the worst
possible symptom) of two of the three other target symptoms (hallucinations,
sedation, and myoclonus) scored

5. Patients are 18 years of age or older

6. Patients have life expectancy of >/= 1 week as determined by their treating
physicians

7. Patients who score < 13 (normal range) in the Memorial Delirium Assessment Scale
(MDAS) and are able to give written informed consent

8. Patients must be able to tolerate the parenteral treatment application device
(butterfly cannula or intravenous access)

9. Patients must have a primary caregiver

10. Patients must reside within 60 miles of M. D. Anderson Cancer Center. Exception to
this is for patients referred from Odyssey Health Care of Conroe, patients referred
from this site must reside within 75 miles of M.D. Anderson Cancer Center.

11. Inclusion criteria of family caregivers: The family caregiver is a person who is
patient's spouse, parent, sibling. child or significant other

12. The family caregiver must reside with the patient and is responsible for the care of
the patient. Exception to this is for patients who are admitted to In Patient hospice
or nursing homes/rehabilitation centers and are under the care of the hospice.

13. The family caregiver must be 18 years of age or older

14. The family caregiver must be willing to be interviewed by the research nurse and sign
written informed consent

Exclusion Criteria:

1. Patient's refuse to participate in the study or are not competent to give informed
consent

2. Patients are suffering from severe dehydration defined as decreased blood pressure or
low perfusion of limbs, decreased level of consciousness, or no urine output for 12
hours

3. Patients with history or clinical evidence of renal failure. Creatinine (Cr) >1.5 *
Upper Limit of Normal (ULN). (M.D. Anderson Cr ULN=1.5 mg/dl). Therefore, a patient
with Creatinine of > 2.25 mg/dl will be excluded.

4. Patients with history or clinical evidence of congestive heart failure

5. Patients who are not able to complete the baseline assessment forms

6. Patients have history of bleeding disorders demonstrated by clinical evidence of
active bleeding, hematuria, hematoma, ecchymoses, and petechiae

7. Patients with brain metastasis, leptomeningeal disease or primary brain tumors will
be eligible for participation in this study as long as there is no evidence of
altered mental status as demonstrated by a normal score on the Memorial Delirium
Assessment Scale (MDAS).

8. The family caregiver refuses to participate in the study

9. The family caregiver has difficulty understanding the intent of the study