Parenteral Hydration in Advanced Cancer Patients

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00423722
First received: January 16, 2007
Last updated: November 16, 2015
Last verified: November 2015
  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 4 Days Later (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion) ] [ Designated as safety issue: No ]
    Symptom burden, assessed using the Edmonton Symptom assessment scale, which has been validated in the cancer population. Participants are asked to rate the severity of their symptoms over the previous 24 hours using a numerical rating scale of 0-10, with 0 meaning that the symptom is absent and 10 meaning the worst possible symptom. The mean is a composite outcome where change in the sum of 4 dehydration symptoms (fatigue, myoclonus, sedation and hallucinations) between day 4 and baseline ranged from 0-40 daily. The reported value was the mean of average change in patients' scores per group.


Secondary Outcome Measures:
  • Reduced Symptom Burden as Measured by RASS, MDAS and UMRS [ Time Frame: Baseline to Day 7 ] [ Designated as safety issue: No ]
    Participants rated delirium, quality of life, and overall survival using Richmond agitation sedition scale (RASS) where +4 is "Combative" to -5 is "Unarousable"; Memorial delirium assessment scale (MDAS), a ten-item, clinician-rated scale from 0 (none) to 3 (severe) for severity of delirium, for a total range of 0-30; and Unified Myoclonus Rating Scale (UMRS) 5-functional scores rated 0 to 4, for a total range of 0-20 where higher scores indicate more severe involuntary movements. Higher scores indicate worse outcomes for each scale, i.e. RASS more agitation, MDAS more delirium and UMRS more severe involuntary movements. The mean represents change in combined participant daily scores for each scale between Baseline and Day 4 assessments then separately Day 7 assessments. Reported value is mean of average change in patients' scores per group. Reported values reflect changes from baseline, either median decreases (less than 0), no change (0) or increases (greater than 0).

  • 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 ] [ Designated as safety issue: No ]
    Change between Day 7 to Baseline in FACIT-F (Functional Assessment of Chronic illness Therapy-Fatigue) & FACT-G (Functional Assessment of Cancer Therapy-General) scores. Participants rate quality of life using FACT-G consisting of 33 questions with 5 domains assessing physical and social, emotional & functional well being & relationship with physician, remaining 5 assess extent to which each domain affects overall quality of life on 5-point scale from 0 (not at all) to 4 (very much); total score obtained by summing individual subscale scores (0-132). FACIT-F consists of 13 items where participants rate intensity of fatigue & its related symptoms on a scale of 0-4 from 0 "not at all" to 4 "very much." The responses to FACIT fatigue questionnaire are each measured on 4‐point Likert scale with total score ranges from 0 to 52. High scores represent less fatigue. Reported is the mean change of the summed value of all reported scores for the FACT-G or the FACIT-F from baseline to Day 7.

  • 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) ] [ Designated as safety issue: No ]
    Secondary outcomes included delirium, quality of life, and overall survival. The Nursing delirium screening scale (NuDESC) was used to assess delirium. NuDESC is a validated observational instrument conducted by research staff based on input from family caregivers. Five symptoms (disorientation, inappropriate behavior, inappropriate communication, illusions or hallucinations, and psychomotor retardation) are each given a score from 0 to 2, for a possible total score of 10. A higher NuDESC score indicates increased symptoms of delirium. It was observed a trend for lesser decline (delirium) in the hydration group, and significant worsening of night-time NuDESC scores in the placebo group.

  • Change in Dehydration as Measured by Dehydration Assessment Scale [ Time Frame: Baseline to Day 7 ] [ Designated as safety issue: No ]
    Dehydration was assessed by using the Dehydration Assessment Scale on the basis of three physical findings, moisture on the mucous membranes of the mouth (0=moist, 1=somewhat dry, 2=dry), axillary moisture (0=moist, 1=dry) and sunkenness of the eyes (0=normal, 1=slight sunken, 2=sunken). These signs are selected due to their significant correlations with biological dehydration, as previously confirmed by elderly patients. The dehydration score (range 0-7) is calculated as the total of these 3 scores, a higher score indicates a higher level of dehydration. The reported value was the mean of average change in patients' scores per group.


Enrollment: 262
Study Start Date: January 2007
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydration: Normal Saline (salt water)
Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily
Drug: Saline
1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
Placebo Comparator: 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.
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
Houston Hospice and Palliative Care System
Houston, Texas, United States, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Odyssey Healthcare of Houston
Houston, Texas, United States, 77054
Vitas Healthcare
Houston, Texas, United States, 77081
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Eduardo Bruera, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
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
Results First Received: July 5, 2012
Last Updated: November 16, 2015
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

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

ClinicalTrials.gov processed this record on May 26, 2016