Parenteral Hydration in Advanced Cancer Patients

NCT00423722 | Completed Results DMC

• 3 other identifiers: 2006-0494R01CA122292-01NCI-2010-00984
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Advanced Cancer; Dehydration

Keywords

Advanced Cancer; Hospice Care; Caregiver; Saline; Hydration; Dehydration

Outcome Measures

Primary Outcomes (1)

• Participant Reduced Symptom Burden

  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.

  From Baseline to 4 Days Later (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion)

Secondary Outcomes (4)

• Reduced Symptom Burden as Measured by RASS, MDAS and UMRS

  Baseline to Day 7

• Change in Quality of Life and Fatigue as Measured by FACIT-F and FACT-G From Baseline to Day 7

  Baseline to Day 7

• Reduced Symptom Burden (From Baseline to 7 Days Post Infusion)

  Baseline to Day 7 (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion)

• Change in Dehydration as Measured by Dehydration Assessment Scale

  Baseline to Day 7

Study Arms (2)

Hydration: Normal Saline (salt water)

EXPERIMENTAL

Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily

Drug: Saline

Placebo: Lower Saline

PLACEBO COMPARATOR

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

Interventions

Saline DRUG

1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.

Hydration: Normal Saline (salt water)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< 13 (normal range) in the Memorial Delirium Assessment Scale (MDAS) and are able to give written informed consent
• Patients must be able to tolerate the parenteral treatment application device (butterfly cannula or intravenous access)
• Patients must have a primary caregiver
• 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.
• 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.
• The family caregiver must be 18 years of age or older
• The family caregiver must be willing to be interviewed by the research nurse and sign written informed consent

You may not qualify if:

• Patient's refuse to participate in the study or are not competent to give informed consent
• 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
• Patients with history or clinical evidence of renal failure. Creatinine \>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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (5)

Odyssey Healthcare of Conroe

Conroe, Texas, 77304, United States

Location

Houston Hospice and Palliative Care System

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Odyssey Healthcare of Houston

Houston, Texas, 77054, United States

Location

Vitas Healthcare

Houston, Texas, 77081, United States

Location

Related Publications (1)

• Bruera E, Hui D, Dalal S, Torres-Vigil I, Trumble J, Roosth J, Krauter S, Strickland C, Unger K, Palmer JL, Allo J, Frisbee-Hume S, Tarleton K. Parenteral hydration in patients with advanced cancer: a multicenter, double-blind, placebo-controlled randomized trial. J Clin Oncol. 2013 Jan 1;31(1):111-8. doi: 10.1200/JCO.2012.44.6518. Epub 2012 Nov 19.

  PMID: 23169523 RESULT

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Dehydration

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Eduardo Bruera, MD / Professor
• Organization: UT MD Anderson Cancer Center

ebruera@mdanderson.org

713-792-6085

Study Officials

• Eduardo Bruera, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2007
• First Posted: January 18, 2007
• Study Start: January 9, 2007
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: March 12, 2024
• Results First Posted: December 17, 2015

Record last verified: 2024-02

Locations

US (5)