Parenteral Hydration in Advanced Cancer Patients

Completed · Not applicable · Has a placebo group

Conditions studied: Advanced Cancer, Dehydration

In brief

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. Objectives: 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.

Key facts

Study ID: NCT00423722
Run by: M.D. Anderson Cancer Center
People needed: 262
Starts: 2007-01-09
Expected to finish: 2013-05-01
Last updated by the study team: 2024-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Patients with advanced cancer (local recurrence or metastatic disease) admitted to hospice care
Patients have reduced oral intake of fluids, as determined by clinical assessment.
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
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
Patients are 18 years of age or older
Patients have life expectancy of >/= 1 week as determined by their treating physicians
Patients who score < 13 (normal range) in the Memorial Delirium Assessment Scale (MDAS) and are able to give written informed consent
Patients must be able to tolerate the parenteral treatment application device (butterfly cannula or intravenous access)
Patients must have a primary caregiver
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.
Inclusion criteria of family caregivers: The family caregiver is a person who is patient's spouse, parent, sibling. child or significant other
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.
The family caregiver must be 18 years of age or older
The family caregiver must be willing to be interviewed by the research nurse and sign written informed consent

You may not qualify if…

Patient's refuse to participate in the study or are not competent to give informed consent
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
Patients with history or clinical evidence of renal failure. Creatinine >1.5 x *Upper Limit of Normal. (M.D. Anderson Cr ULN=1.5 mg/dl). Therefore, a patient with Creatinine of (CR)> 2.25 mg/dl will be excluded.
Patients with history or clinical evidence of congestive heart failure
Patients who are not able to complete the baseline assessment forms
Patients have history of bleeding disorders demonstrated by clinical evidence of active bleeding, hematuria, hematoma, ecchymoses, and petechiae
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).
The family caregiver refuses to participate in the study
The family caregiver has difficulty understanding the intent of the study

Where it is running

Odyssey Healthcare of Conroe — Conroe, Texas, United States
Houston Hospice and Palliative Care System — Houston, Texas, United States
University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Odyssey Healthcare of Houston — Houston, Texas, United States
Vitas Healthcare — Houston, Texas, United States

Full record on ClinicalTrials.gov

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