N/A
N=129
Parenteral Hydration in Advanced Cancer Patients
Advanced Cancer · Dehydration
Bottom Line
View on ClinicalTrials.gov: NCT00423722 ↗Enrolled (actual)
129
Serious AEs
24.0%
Results posted
Dec 2015
Primary outcome: Primary: Participant Reduced Symptom Burden — -3.3; -2.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Reduced Symptom Burden |
-3.3; -2.8 | — |
| SECONDARY Reduced Symptom Burden as Measured by RASS, MDAS and UMRS |
0; 0; 0; -1; 1; 3.5 | — |
| SECONDARY Change in Quality of Life and Fatigue as Measured by FACIT-F and FACT-G From Baseline to Day 7 |
6.7; 2.6; 9.1; 1.4 | — |
| SECONDARY Reduced Symptom Burden (From Baseline to 7 Days Post Infusion) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change in Dehydration as Measured by Dehydration Assessment Scale |
-0.8; -0.6; -1.0; -0.5 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients with advanced cancer (local recurrence or metastatic disease) admitted to hospice care
- Patients have reduced oral intake of fluids, 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 1.5 x *Upper Limit of Normal. (M.D. Anderson Cr ULN=1.5 mg/dl). Therefore, a patient with Creatinine of (CR)> 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
Data sourced from ClinicalTrials.gov (NCT00423722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.