DehydrationNCT03799380
DRIHNC - Dehydration Reduction in Head & Neck Cancer
A study testing Gatorade G2 in people with Dehydration and Head & Neck Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to decrease the rate of visits to the Emergency Department (ED) and Acute Care Clinics (ACC) for dehydration for head \& neck (H\&N) and esophageal cancer patients that are given Gatorade while receiving radiation therapy with or without chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dehydration, Head & Neck Cancer, Esophageal Cancer
- What is being tested?
- Gatorade G2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2019to 5 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have histologically confirmed primary invasive cancer of the H\&N (Nasopharynx/Nasal Cavity, Oral cavity, Oropharynx, Larynx, Hypopharynx) or Esophagus.
- Histologies: squamous cell carcinoma, adenocarcinoma, adenoid cystic carcinoma, sinonasal undifferentiated carcinoma Stages: Any stage that necessitates radiation therapy (either definitive, neoadjuvant or adjuvant) as per standard practice guidelines (NCCN, ASTRO)
- Subjects must have received no prior radiation therapy to the head, neck, thorax or abdomen in the last 1 year (with the exception of scalp squamous cell or basal cell carcinoma.
- ECOG Performance status 0-2.
- Life expectancy of ≥ 3 months, in the opinion of and as documented by the investigator.
- Subjects must have organ and marrow function based on lab values deemed acceptable to proceed with radiation therapy. No additional or specific lab value cutoffs are required for this protocol given the nature of the intervention. General guidelines are provided below.
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- Hemoglobin ≥ 7 g/dl
- Absolute neutrophil count ≥ 500/mcL
- Platelet count ≥ 50,000/mcL
- Total bilirubin within normal institutional limits
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
- HIV-positive subjects on combination antiretroviral therapy are eligible.
Who cannot join
- The presence of any of the following will exclude a subject from study enrollment.
- Prior radiation therapy to the head, neck, thorax or abdomen in the last year, with the exception of scalp squamous cell or basal cell carcinoma.
- Patients with active, uncontrolled, symptomatic volume overload congestive heart failure.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: DRIHNC - Dehydration Reduction in Head & Neck Cancer: Daily Oral Fluid and Electrolyte Maintenance to Prevent Acute Care Clinic and Emergency Department Visits for Patients Receiving Radiation With or Without Chemotherapy/Immunotherapy for Head & Neck and Esophageal Cancer.
The purpose of this study is to decrease the rate of visits to the Emergency Department (ED) and Acute Care Clinics (ACC) for dehydration for head \& neck (H\&N) and esophageal cancer patients that are given Gatorade while receiving radiation therapy with or without chemotherapy.
Read the detailed description
Among patients with cancer of the H\&N or esophagus, complications related to dehydration are fairly common, and can result in requiring IV fluid support in an ACC setting, ED or even inpatient admission. By instructing participants to drink a reasonable amount of a common electrolyte-rich energy drink from the initiation of treatment through its completion, the hypothesis will be tested that this inexpensive and easily administered preventative strategy can significantly decrease the rate of ACC and ED visits.
The objectives of this study are to decrease the frequency of ACC visits during the course of radiation therapy and decrease the frequency of ED visits during the course of radiation therapy. The study team also seeks to decrease the incidence of orthostatic vital signs during the course of radiation therapy and decrease the number of days of missed treatments due to radiation toxicity during the course of radiation therapy.
In the pilot cohort, participants will be given Gatorade G2 to drink daily during the course of radiation, along with standard of care nutritional support from dietitians. The randomized Phase 2 cohort has two study groups. Group 1 will receive standard of care nutritional support. Group 2 will receive standard of care nutritional support plus the study agent, Gatorade G2.
- Conditions
- Dehydration, Head & Neck Cancer, Esophageal Cancer
- Being tested
- Gatorade G2, Standard of care nutritional support
- Medical subject headings
- Dehydration, Head and Neck Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gatorade G2Dietary supplement
Gatorade (G2), 20 oz. bottle, daily through the entire course of radiation therapy (approximately 5-7 weeks)
Standard of care nutritional supportDietary supplement
Standard of care nutritional support
| Study group | Role | What they receive |
|---|---|---|
| Control - Standard of Care | Active comparator | Standard of care nutritional support Receives: Dietary Supplement: Standard of care nutritional support |
| Experimental - Gatorade | Experimental | Standard of care nutritional support with the addition of daily Gatorade G2 Receives: Dietary Supplement: Gatorade G2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACC visits
ACC visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.
Measured: Up to 11 weeks after start of treatment
ED visits
Number of ED visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.
Measured: Up to 11 weeks after start of treatment
Secondary outcomes (2)
Incidence of orthostatic vital signs
Number of orthostatic vital signs during the course of radiation therapy assessed at weekly visits.
Measured: Up to 11 weeks after start of treatment
Missed days of radiation +/- chemotherapy/immunotherapy treatment
Number of missed days of radiation treatment among H\&N and esophageal cancer patients undergoing radiation +/- chemotherapy/immunotherapy during the course of treatment.
Measured: Up to 7 weeks after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start5 Nov 2019
- Primary completion5 May 2021
- Study completion5 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- More trials run by Case Comprehensive 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
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisha Fredman, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799380
- Sponsor's protocol ID
- CASE8318
- Status last verified
- Nov 2021
- First submitted
- 8 Jan 2019
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DRIHNC - Dehydration Reduction in Head & Neck Cancer: Daily Oral Fluid and Electrolyte Maintenance to Prevent Acute Care Clinic and Emergency Department Visits for Patients Receiving Radiation With or Without Chemotherapy/Immunotherapy for Head & Neck and Esophageal Cancer.
- ClinicalTrials.gov ID
- NCT03799380
- Acronym / sponsor ID
- CASE8318
- Conditions
- Dehydration, Head & Neck Cancer, Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 5 May 2021 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to decrease the rate of visits to the Emergency Department (ED) and Acute Care Clinics (ACC) for dehydration for head \& neck (H\&N) and esophageal cancer patients that are given Gatorade while receiving radiation therapy with or without chemotherapy.
Detailed description
Among patients with cancer of the H\&N or esophagus, complications related to dehydration are fairly common, and can result in requiring IV fluid support in an ACC setting, ED or even inpatient admission. By instructing participants to drink a reasonable amount of a common electrolyte-rich energy drink from the initiation of treatment through its completion, the hypothesis will be tested that this inexpensive and easily administered preventative strategy can significantly decrease the rate of ACC and ED visits.
The objectives of this study are to decrease the frequency of ACC visits during the course of radiation therapy and decrease the frequency of ED visits during the course of radiation therapy. The study team also seeks to decrease the incidence of orthostatic vital signs during the course of radiation therapy and decrease the number of days of missed treatments due to radiation toxicity during the course of radiation therapy.
In the pilot cohort, participants will be given Gatorade G2 to drink daily during the course of radiation, along with standard of care nutritional support from dietitians. The randomized Phase 2 cohort has two study groups. Group 1 will receive standard of care nutritional support. Group 2 will receive standard of care nutritional support plus the study agent, Gatorade G2.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control - Standard of Care | Active comparator | Dietary Supplement: Standard of care nutritional supportStandard of care nutritional support |
| Experimental - Gatorade | Experimental | Dietary Supplement: Gatorade G2Standard of care nutritional support with the addition of daily Gatorade G2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects must have histologically confirmed primary invasive cancer of the H\&N (Nasopharynx/Nasal Cavity, Oral cavity, Oropharynx, Larynx, Hypopharynx) or Esophagus.
- Histologies: squamous cell carcinoma, adenocarcinoma, adenoid cystic carcinoma, sinonasal undifferentiated carcinoma Stages: Any stage that necessitates radiation therapy (either definitive, neoadjuvant or adjuvant) as per standard practice guidelines (NCCN, ASTRO)
- Subjects must have received no prior radiation therapy to the head, neck, thorax or abdomen in the last 1 year (with the exception of scalp squamous cell or basal cell carcinoma.
- ECOG Performance status 0-2.
- Life expectancy of ≥ 3 months, in the opinion of and as documented by the investigator.
Key exclusion criteria (3 listed)
- The presence of any of the following will exclude a subject from study enrollment.
- Prior radiation therapy to the head, neck, thorax or abdomen in the last year, with the exception of scalp squamous cell or basal cell carcinoma.
- Patients with active, uncontrolled, symptomatic volume overload congestive heart failure.
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 |
|---|---|---|
| Gatorade G2Gatorade (G2), 20 oz. bottle, daily through the entire course of radiation therapy (approximately 5-7 weeks) | Dietary supplement | Experimental - Gatorade |
| Standard of care nutritional supportStandard of care nutritional support | Dietary supplement | Control - Standard of Care |
Primary outcome
ACC visits
Time frame: Up to 11 weeks after start of treatment
ACC visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.
ED visits
Time frame: Up to 11 weeks after start of treatment
Number of ED visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.
2 secondary outcomes
Incidence of orthostatic vital signs
Time frame: Up to 11 weeks after start of treatment
Missed days of radiation +/- chemotherapy/immunotherapy treatment
Time frame: Up to 7 weeks after start of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
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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.
Elisha Fredman, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gatorade G2 in people with Dehydration and Head & Neck Cancer, run by Case Comprehensive Cancer Center at 1 site 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 12 inclusion and 3 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 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ACC visits (time frame: Up to 11 weeks after start of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2021.