Parenteral Hydration in Advanced Cancer Patients: A Randomized Controlled Trial

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DESCRIPTION (provided by applicant): 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.