Parenteral Hydration in Advanced Cancer Patients - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center National Institutes of Health (NIH)
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00423722

Purpose

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.

Condition	Intervention
Advanced Cancer Dehydration	Drug: Saline

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Parenteral Hydration in Advanced Cancer Patients - A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Caregivers Hospice Care

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Reduced symptom burden, defined as change in sum of 4 symptoms (fatigue, sedation, myoclonus and hallucinations) [ Time Frame: From Baseline to 7 Days Later (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion) ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	January 2007
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental Normal Saline (salt water)	Drug: Saline 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
Group 2: Experimental Lower Amount of Normal Saline (salt water)	Drug: Saline 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients with advanced cancer (local recurrence or metastatic disease) admitted to hospice care
Patients with an oral fluid intake less than 1000 mL/day, 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

Exclusion Criteria:

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 ULN. (M.D. Anderson Cr ULN=1.5 mg/dl). Therefore, a patient with Creatinine of > 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423722

Contacts

Contact: Eduardo Bruera, MD	713-792-6085
Contact: Cathy Robb, RN		cjrobb@mdanderson.org

Locations

United States, Texas
Odyssey Healthcare of Conroe	Recruiting
Conroe, Texas, United States, 77304
Odyssey Healthcare of Houston	Recruiting
Houston, Texas, United States, 77054
Houston Hospice and Palliative Care System	Recruiting
Houston, Texas, United States, 77030
Vitas Healthcare	Recruiting
Houston, Texas, United States, 77081
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Eduardo Bruera, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Eduardo Bruera, MD

U.T. M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Eduardo Bruera, MD/Professor )
Study ID Numbers:	2006-0494, R01CA122292-01
Study First Received:	January 16, 2007
Last Updated:	June 29, 2009
ClinicalTrials.gov Identifier:	NCT00423722 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Advanced Cancer
Hospice Care
Caregiver

Saline
Hydration
Dehydration

Study placed in the following topic categories:

Metabolic Diseases
Water-Electrolyte Imbalance
Metabolic Disorder
Dehydration

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Metabolic Diseases
Water-Electrolyte Imbalance
Dehydration

ClinicalTrials.gov processed this record on July 06, 2009