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Parenteral Hydration in Advanced Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00423722
First Posted: January 18, 2007
Last Update Posted: December 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
Results First Submitted: July 5, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Supportive Care
Conditions: Advanced Cancer
Dehydration
Intervention: Drug: Saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: 01/07/2007 - 05/02/2011. Participating sites included Silverado Hospice, Odyssey Hospice, Vitas Hospice, Houston Hospice and Christus Visiting Nurse Association (VNA) Hospice in the Greater Houston area.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Hydration: Normal Saline (Salt Water) Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
Placebo: Lower Saline Group 2: Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.

Participant Flow:   Overall Study
    Hydration: Normal Saline (Salt Water)   Placebo: Lower Saline
STARTED   63   66 
COMPLETED   49   53 
NOT COMPLETED   14   13 
Death                4                4 
Declined to participate                2                3 
Unable to complete questionnaires                4                4 
Withdrawal by Subject                4                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Hydration: Normal Saline (Salt Water) Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
Placebo: Lower Saline Group 2: Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
Total Total of all reporting groups

Baseline Measures
   Hydration: Normal Saline (Salt Water)   Placebo: Lower Saline   Total 
Overall Participants Analyzed 
[Units: Participants]
 63   66   129 
Age 
[Units: Years]
Mean (Full Range)
 67 
 (43 to 92) 
 67 
 (41 to 92) 
 67 
 (41 to 92) 
Age, Customized 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   27   29   56 
>=65 years   36   37   73 
Gender 
[Units: Participants]
     
Female   25   36   61 
Male   38   30   68 
Region of Enrollment 
[Units: Participants]
     
United States   63   66   129 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Participant Reduced Symptom Burden   [ Time Frame: From Baseline to 4 Days Later (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion) ]

2.  Secondary:   Reduced Symptom Burden as Measured by RASS, MDAS and UMRS   [ Time Frame: Baseline to Day 7 ]

3.  Secondary:   Change in Quality of Life and Fatigue as Measured by FACIT-F and FACT-G From Baseline to Day 7   [ Time Frame: Baseline to Day 7 ]

4.  Secondary:   Reduced Symptom Burden (From Baseline to 7 Days Post Infusion)   [ Time Frame: Baseline to Day 7 (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion) ]

5.  Secondary:   Change in Dehydration as Measured by Dehydration Assessment Scale   [ Time Frame: Baseline to Day 7 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study had a planned sample size of 150 participants but due to funding issues recruitment was halted after 129 patients; additionally, participants with delirium or severe dehydration were excluded for logistic purposes.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Principal investigator: Eduardo Bruera, MD / Professor
Organization: UT MD Anderson Cancer Center
phone: 713-563-4157
e-mail: CR_Study_Registration@mdanderson.org


Publications of Results:

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00423722     History of Changes
Other Study ID Numbers: 2006-0494
R01CA122292-01 ( U.S. NIH Grant/Contract )
First Submitted: January 16, 2007
First Posted: January 18, 2007
Results First Submitted: July 5, 2012
Results First Posted: December 17, 2015
Last Update Posted: December 17, 2015