Parenteral Hydration in Advanced Cancer Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by M.D. Anderson Cancer Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00423722
First received: January 16, 2007
Last updated: June 22, 2012
Last verified: June 2012
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Parenteral Hydration in Advanced Cancer Patients - A Randomized Controlled Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Participant Reduced Symptom Burden [ 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 ]
    Reduced symptom burden, defined as change in sum of 4 symptoms (fatigue, sedation, myoclonus and hallucinations) from Baseline to 7 Days post infusion (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion)


Estimated Enrollment: 300
Study Start Date: January 2007
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Normal Saline (salt water)
Drug: Saline
1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
Experimental: Group 2
Lower Amount of Normal Saline (salt water)
Drug: Saline
100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.

  Show Detailed Description

  Eligibility

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

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 (Cr) >1.5 * Upper Limit of Normal (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
Odyssey Healthcare of Conroe
Conroe, Texas, United States, 77304
Odyssey Healthcare of Houston
Houston, Texas, United States, 77054
Houston Hospice and Palliative Care System
Houston, Texas, United States, 77030
Vitas Healthcare
Houston, Texas, United States, 77081
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Eduardo Bruera, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided by M.D. Anderson Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00423722     History of Changes
Other Study ID Numbers: 2006-0494, R01CA122292-01
Study First Received: January 16, 2007
Last Updated: June 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Hospice Care
Caregiver
Saline
Hydration
Dehydration

Additional relevant MeSH terms:
Dehydration
Neoplasms
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014