Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423722
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2007-01-16
Brief Title:
Parenteral Hydration in Advanced Cancer Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Parenteral Hydration in Advanced Cancer Patients - A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
11 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
12 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
13 Describe the meaning patients and primary caregivers attribute to dehydration and re-hydration at the end of patients lives
Objectives
11 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
12 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
13 Describe the meaning patients and primary caregivers attribute to dehydration and re-hydration at the end of patients lives
Detailed Description:
For Caregivers
Symptoms of dehydration may include fatigue muscle contractions the need for sedation calming medication and hallucinations where something is sensed that is not actually there Hydration allows the body to get rid of the waste products from medications and other chemicals When the fluid levels in the body are increased the brain function may directly improve
If the patient under your care is found to be eligible to take part in this study he or she will be randomly assigned as in the toss of the coin to one of 2 groups Participants in Group 1 will receive normal saline salt water once a day Participants in Group 2 will receive a lower amount of normal saline once a day This lower amount is small enough to be considered a placebo Doctors call something a placebo if it looks like the substance being tested but has no active ingredients or in this case few active ingredients
Both you and the patient will be asked to complete a number of questionnaires at the beginning of the study on Days 1-7 and then every 3-5 days after that Your questionnaires will ask about the feelings you may have about hydration and the care that you are providing to the patient Each days questionnaires will take about 30 minutes
Both you and the patient will also be interviewed by researchers at the beginning of the study and on Day 4 - 2 days The interviews will include questions about what it has been like for the patient to get fluids whether the fluid was more like food or medicine whether the patient has ever gotten dehydrated and how you manage the patients care The interviews should each take about 30 minutes The interviews in this study will be audio taped so the information can be studied by researchers Only the research staff will listen to the audio tape of the interviews
If the patient goes off study your participation in the study will be over
This is an investigational study Up to 150 patients and 150 caregivers will take part in this study All will be enrolled at M D Anderson
For Patients
Before you can start treatment on this study you will have screening tests These tests will help the doctor decide if you are eligible to take part in this study You will be asked to complete a questionnaire It will ask questions about your cancer diagnoses the medications you are taking and the symptoms you are having The questionnaire also asks about your memory of being dehydrated what it was like for you to get fluids how you manage your care and whether the fluid was more like food or medicine It should take about 30 minutes to complete
Both you and your caregiver will also be interviewed by researchers There will be questions about what it has been like for you to get fluids whether the fluid was more like food or medicine and whether you have ever gotten dehydrated Each interview should take about 30 minutes The interviews in this study will be audio taped so the information can be studied by researchers
The study staff will also check you for symptoms of muscle contraction one of the signs of dehydration The study staff will videotape your face arms hands legs and toes for a total 3-5 minutes on Days 1 4 and 7 and then every 3-5 days after that
As part of the screening tests you will also have blood drawn about 2 teaspoons for routine tests You will be asked questions about your ability to perform daily activities performance status evaluation You will be asked about any side effects you may have including muscle contractions You will also be asked to list any pain medications or other medications that you take
If you are found to be eligible to take part in this study you will be randomly assigned as in the toss of the coin to one of two groups Participants in Group 1 will receive normal saline salt water once a day Participants in Group 2 will receive a lower amount of normal saline once a day This lower amount is small enough to be considered a placebo Doctors call something a placebo if it looks like the substance being tested but has no active ingredients or in this case few active ingredients You will have an equal chance of being placed in either group Neither you nor any of the medical staff or researchers on this study will know which dose you are receiving
The research nurse will ask you to complete several questionnaires that ask questions about dehydration and the symptoms you may have experienced including fatigue The questionnaires will be completed on Days 1-7 and then every 3-5 days after that In total each days questionnaires should take about 30 minutes Your caregiver will also be asked about his or her memory of your dehydration On Day 7 you will have blood drawn about 2 teaspoons for routine tests
Both you and your caregiver will also be interviewed by researchers on Day 4 - 2 days and then every 3-5 days after that The interviews will be like the ones at screening
Starting on Day 1 of the study you will receive saline through a catheter in a vein over 4 hours every day If you already have a central venous catheter you will receive the saline through that catheter If you do not have a central venous catheter the saline will be infused under the skin Either way the infusion will last about 4 hours
During each infusion an infusion research nurse will check to make sure that the saline is given properly This nurse will know which treatment group you have been assigned to
Every day the research nurse will ask you about the dehydration and any side effects you may have Every day the research nurse will also check the place where the infusion is given to make sure there is no infection
On Days 1-7 and then every 3-5 days the research nurse will also check for any dehydration symptoms including the need for sedation any restless feelings or actions andor muscle contractions You will have a performance status evaluation daily On Days 1-7 the research nurse will ask about any pain medications or other medications that you have taken
Every day 2 hours - 3 hours after the infusion ends you will also be checked by an assessment research nurse who will not know which treatment group you are in The assessment research nurse will ask about any symptoms you may have The study staff will also check you for symptoms of muscle contraction one of the signs of dehydration The study staff will videotape your face arms hands legs and toes for a total 3-5 minutes on Days 1 4 and 7 and then every 3-5 days after that
You may remain on study to receive the daily infusions for as long as you are benefitting up to Day 14 - 3 days On Day 14 - 3 days you will be taken off study and you will have off study assessments which include questions about your symptoms including fatigue performance status medications you are taking and dehydration symptoms If intolerable side effects occur you will be taken off study and given appropriate medical care If you wish to continue receiving hydration fluids after you are taken off study Day 14 - 3 days you may discuss this option with your attending hospice physician You may receive a liter of normal saline each day under the skin Treatment will be given by hospice nurse Fluid will be provided to you free of charge
This is an investigational study Up to 150 patients and 150 caregivers will take part in this study All will be enrolled at M D Anderson
Symptoms of dehydration may include fatigue muscle contractions the need for sedation calming medication and hallucinations where something is sensed that is not actually there Hydration allows the body to get rid of the waste products from medications and other chemicals When the fluid levels in the body are increased the brain function may directly improve
If the patient under your care is found to be eligible to take part in this study he or she will be randomly assigned as in the toss of the coin to one of 2 groups Participants in Group 1 will receive normal saline salt water once a day Participants in Group 2 will receive a lower amount of normal saline once a day This lower amount is small enough to be considered a placebo Doctors call something a placebo if it looks like the substance being tested but has no active ingredients or in this case few active ingredients
Both you and the patient will be asked to complete a number of questionnaires at the beginning of the study on Days 1-7 and then every 3-5 days after that Your questionnaires will ask about the feelings you may have about hydration and the care that you are providing to the patient Each days questionnaires will take about 30 minutes
Both you and the patient will also be interviewed by researchers at the beginning of the study and on Day 4 - 2 days The interviews will include questions about what it has been like for the patient to get fluids whether the fluid was more like food or medicine whether the patient has ever gotten dehydrated and how you manage the patients care The interviews should each take about 30 minutes The interviews in this study will be audio taped so the information can be studied by researchers Only the research staff will listen to the audio tape of the interviews
If the patient goes off study your participation in the study will be over
This is an investigational study Up to 150 patients and 150 caregivers will take part in this study All will be enrolled at M D Anderson
For Patients
Before you can start treatment on this study you will have screening tests These tests will help the doctor decide if you are eligible to take part in this study You will be asked to complete a questionnaire It will ask questions about your cancer diagnoses the medications you are taking and the symptoms you are having The questionnaire also asks about your memory of being dehydrated what it was like for you to get fluids how you manage your care and whether the fluid was more like food or medicine It should take about 30 minutes to complete
Both you and your caregiver will also be interviewed by researchers There will be questions about what it has been like for you to get fluids whether the fluid was more like food or medicine and whether you have ever gotten dehydrated Each interview should take about 30 minutes The interviews in this study will be audio taped so the information can be studied by researchers
The study staff will also check you for symptoms of muscle contraction one of the signs of dehydration The study staff will videotape your face arms hands legs and toes for a total 3-5 minutes on Days 1 4 and 7 and then every 3-5 days after that
As part of the screening tests you will also have blood drawn about 2 teaspoons for routine tests You will be asked questions about your ability to perform daily activities performance status evaluation You will be asked about any side effects you may have including muscle contractions You will also be asked to list any pain medications or other medications that you take
If you are found to be eligible to take part in this study you will be randomly assigned as in the toss of the coin to one of two groups Participants in Group 1 will receive normal saline salt water once a day Participants in Group 2 will receive a lower amount of normal saline once a day This lower amount is small enough to be considered a placebo Doctors call something a placebo if it looks like the substance being tested but has no active ingredients or in this case few active ingredients You will have an equal chance of being placed in either group Neither you nor any of the medical staff or researchers on this study will know which dose you are receiving
The research nurse will ask you to complete several questionnaires that ask questions about dehydration and the symptoms you may have experienced including fatigue The questionnaires will be completed on Days 1-7 and then every 3-5 days after that In total each days questionnaires should take about 30 minutes Your caregiver will also be asked about his or her memory of your dehydration On Day 7 you will have blood drawn about 2 teaspoons for routine tests
Both you and your caregiver will also be interviewed by researchers on Day 4 - 2 days and then every 3-5 days after that The interviews will be like the ones at screening
Starting on Day 1 of the study you will receive saline through a catheter in a vein over 4 hours every day If you already have a central venous catheter you will receive the saline through that catheter If you do not have a central venous catheter the saline will be infused under the skin Either way the infusion will last about 4 hours
During each infusion an infusion research nurse will check to make sure that the saline is given properly This nurse will know which treatment group you have been assigned to
Every day the research nurse will ask you about the dehydration and any side effects you may have Every day the research nurse will also check the place where the infusion is given to make sure there is no infection
On Days 1-7 and then every 3-5 days the research nurse will also check for any dehydration symptoms including the need for sedation any restless feelings or actions andor muscle contractions You will have a performance status evaluation daily On Days 1-7 the research nurse will ask about any pain medications or other medications that you have taken
Every day 2 hours - 3 hours after the infusion ends you will also be checked by an assessment research nurse who will not know which treatment group you are in The assessment research nurse will ask about any symptoms you may have The study staff will also check you for symptoms of muscle contraction one of the signs of dehydration The study staff will videotape your face arms hands legs and toes for a total 3-5 minutes on Days 1 4 and 7 and then every 3-5 days after that
You may remain on study to receive the daily infusions for as long as you are benefitting up to Day 14 - 3 days On Day 14 - 3 days you will be taken off study and you will have off study assessments which include questions about your symptoms including fatigue performance status medications you are taking and dehydration symptoms If intolerable side effects occur you will be taken off study and given appropriate medical care If you wish to continue receiving hydration fluids after you are taken off study Day 14 - 3 days you may discuss this option with your attending hospice physician You may receive a liter of normal saline each day under the skin Treatment will be given by hospice nurse Fluid will be provided to you free of charge
This is an investigational study Up to 150 patients and 150 caregivers will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA122292-01 | NIH | None | None |
| NCI-2010-00984 | REGISTRY | NCI CTRP | httpsreporternihgovquickSearchR01CA122292-01 |