NCT00423722

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2007

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2007

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

December 17, 2015

Completed
Last Updated

March 12, 2024

Status Verified

February 1, 2024

Enrollment Period

6.3 years

First QC Date

January 16, 2007

Results QC Date

July 5, 2012

Last Update Submit

February 16, 2024

Conditions

Advanced CancerDehydration

Keywords

Advanced CancerHospice CareCaregiverSalineHydrationDehydration

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

SalineDRUG

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

Hydration: Normal Saline (salt water)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 23169523RESULT

Related Links

MeSH Terms

Conditions

Dehydration

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium 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)