Advanced CancerNCT00423722
Parenteral Hydration in Advanced Cancer Patients
A study testing Saline in people with Advanced Cancer and Dehydration, run by M.D. Anderson Cancer Center at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancer, Dehydration
- What is being tested?
- Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 5 sitesUnited States
- Study dates
- 9 Jan 2007to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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.
- Inclusion criteria of family caregivers: The family caregiver is a person who is patient's spouse, parent, sibling. child or significant other
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Odyssey Healthcare of Conroe
Conroe, Texas, 77304
Houston Hospice and Palliative Care System
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Odyssey Healthcare of Houston
Houston, Texas, 77054
Vitas Healthcare
Houston, Texas, 77081
About this study
Official title: Parenteral Hydration in Advanced Cancer Patients - A Randomized Controlled Trial
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:
Read more
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.
Read the 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 day's 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 patient's 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 day's 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, and/or 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.
- Conditions
- Advanced Cancer, Dehydration
- Being tested
- Saline
- Keywords
- Advanced Cancer, Hospice Care, Caregiver, Saline, Hydration, Dehydration
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
SalineDrug
100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
| Study group | Role | What they receive |
|---|---|---|
| Hydration: Normal Saline (salt water) | Experimental | Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily Receives: 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. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: Baseline to Day 7
Change in Quality of Life and Fatigue as Measured by FACIT-F and FACT-G From Baseline to Day 7
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.
Measured: Baseline to Day 7
Reduced Symptom Burden (From Baseline to 7 Days Post Infusion)
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.
Measured: 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
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.
Measured: Baseline to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study start9 Jan 2007
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Eduardo Bruera, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423722
- Sponsor's protocol ID
- 2006-0494
- Other IDs
- R01CA122292-01, NCI-2010-00984
- Status last verified
- Feb 2024
- First submitted
- 16 Jan 2007
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23169523
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenteral Hydration in Advanced Cancer Patients - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00423722
- Acronym / sponsor ID
- 2006-0494
- Conditions
- Advanced Cancer, Dehydration
- Keywords
- Advanced Cancer, Hospice Care, Caregiver, Saline, Hydration, Dehydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 9 Jan 2007 (actual)
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 18 Jan 2007 (estimated)
- Results
- Posted 17 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 day's 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 patient's 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 day's 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, and/or 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydration: Normal Saline (salt water) | Experimental | Drug: SalineGroup 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily |
| Placebo: Lower Saline | Placebo comparator | Drug: SalineGroup 2: Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily. | Drug | Hydration: Normal Saline (salt water) |
| Saline100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily. | Drug | Placebo: Lower Saline |
Primary outcome
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)
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.
4 secondary outcomes
Reduced Symptom Burden as Measured by RASS, MDAS and UMRS
Time frame: Baseline to Day 7
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
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)
Change in Dehydration as Measured by Dehydration Assessment Scale
Time frame: Baseline to Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23169523Bruera 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.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Bruera, MD principal investigator
M.D. Anderson Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline in people with Advanced Cancer and Dehydration, run by M.D. Anderson Cancer Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00423722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.