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Study Summary
No. 2006-0494:.......Advanced Cancers......Eduardo Bruera......Palliative Care & Rehabilitation Medicine
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Study Summary Title
Study Summary
Number:		2006-0494
Study Title:Parenteral Hydration in Advanced Cancer Patients-A Randomized Controlled Trial
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Physician New Patient Referral
Name:Eduardo BrueraPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Palliative Care & Rehabilitation MedicineReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6085
Contact us about clinical trials
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General Information
Disease Group:Advanced CancersSupported By:N/A
Phase of Study:N/AReturn
Visit:		N/A
Treatment
Agents:		SalineHome Care:Patients will receive maximum 1,000 ml normal saline per day for hydration.
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		The goal of this clinical research study is to learn whether being hydrated
(given liquids) through a catheter in a vein or in the tissue under the skin
can improve symptoms of dehydration.
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Study Objectives / Outcomes
1.1 Determine whether parenteral hydration is superior to placebo in improving symptoms associated with dehydration (such as fatigue, myoclonus, sedation, and hallucinations) in advanced cancer patients receiving hospice care.

1.2 Determine whether parenteral hydration is superior to placebo in delaying the onset or reducing the severity of delirium in patients with advanced cancer receiving hospice care.

1.3 Describe the meaning patients and primary caregivers attribute to dehydration and re-hydration at the end of patient's lives.
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Study Status Information
Study Activation / Registration Date:01/09/2007
IRB Review and Approval Date:07/19/2006
Study Type:Other
Recruitment Status:Closed
Projected Accrual:300
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
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 >1.5 x 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
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Links
Registration Number: NCT00423722
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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