The majority of cancer patients develop decreased oral intake before death. Dehydration can cause or aggravate symptoms such as fatigue, myoclonus, sedation, hallucinations and delirium. The controversy regarding the effects of hydration at the end of life has resulted in heated debate in American media and in medical literature. In the United States, patients with advanced cancer who have dehydration or decreased oral intake nearly always receive parenteral hydration in acute care facilities but almost never in hospices. Unfortunately, the decision of giving or not giving fluid in advanced cancer patients at the end of life is complicated by nearly complete absence of randomized controlled trials focusing on the potential advantages and disadvantages of parenteral hydration. The only randomized, double blind controlled study conducted by our group suggested that parenteral hydration decreased symptoms associated with dehydration in terminally ill cancer patients as compared with placebo. Our long -term goal of this study is to understand the effect of parenteral hydration on the quality and quantity of life in terminally ill cancer patients and their primary caregivers We propose this randomized, controlled clinical trial to determine whether parenteral hydration (1,000 mL normal saline/day) is superior to placebo (100 ml normal saline) in improving symptoms associated with dehydration such as fatigue, myoclonus, sedation, hallucinations and delirium in patients with advanced cancer receiving hospice care, whether parenteral hydration is superior to placebo in delaying the onset or decreased severity of delirium, whether parenteral hydration is superior to placebo in prolonging survival and to describe the meaning of dehydration and re-hydration at the end of life to family primary caregivers. In order to achieve these goals, a battery of symptom assessments will be mesured at study resgistration, during treatment and at the end of the treatment. We hypothesize that patients receiving parenteral hydration will demonstrate reduced symptom burden, delayed onset and reduced severity of delirium, and prolonged survival. In this study, we will test if giving fluid through the vein will improve the symptoms, delay confusion and prolong life in patients who are no longer to drink at the end of life.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA122292-04
Application #
7662430
Study Section
Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
Program Officer
O'Mara, Ann M
Project Start
2006-09-15
Project End
2011-07-31
Budget Start
2009-08-01
Budget End
2011-07-31
Support Year
4
Fiscal Year
2009
Total Cost
$423,396
Indirect Cost
Name
University of Texas MD Anderson Cancer Center
Department
Physical Medicine & Rehab
Type
Other Domestic Higher Education
DUNS #
800772139
City
Houston
State
TX
Country
United States
Zip Code
77030
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