Parenteral Hydration in Advanced Cancer Patients
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.
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.
|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|
- 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.
- 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.
|Study Start Date:||January 2007|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: Hydration: Normal Saline (salt water)
Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily
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.
100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423722
|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|
|Houston, Texas, United States, 77081|
|Principal Investigator:||Eduardo Bruera, MD||M.D. Anderson Cancer Center|