Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Emergencies

Esophageal Neoplasms

Dehydration

Head and Neck Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Water-Electrolyte Imbalance

Metabolic Diseases

Esophageal Cancer

Acute Graft Versus Host Disease

All Drugs and Chemicals

Immunomodulating Agents

Standard of care nutritional support with the addition of daily Gatorade G2

Gatorade (G2), 20 oz. bottle, daily through the entire course of radiation therapy (approximately 5-7 weeks)

Gatorade G2

Standard of care nutritional support

Elisha Fredman, MD

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.

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.

DRIHNC - Dehydration Reduction in Head & Neck Cancer

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.

ACC visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.

Number of ED visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.

Number of orthostatic vital signs during the course of radiation therapy assessed at weekly visits.

Number of missed days of radiation treatment among H\&N and esophageal cancer patients undergoing radiation +/- chemotherapy/immunotherapy during the course of treatment.

Case Comprehensive Cancer Center

Blood and Lymph Conditions

Hematologic Neoplasms

Hematologic Diseases

Patients receive enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge.

Patients receive standard of care nutritional support.

Patients receive fiber supplementation PO or enterally starting 14 days prior to day 1 of conditioning chemotherapy and continuing until discharge from the hospital. Stool will be collected at different time points throughout the study. Patients may also undergo blood sample collection throughout the study.

Given enteral nutrition via nasoenteric feeding

Kate Farms 1.0

Given standard of care, which may be parenteral nutrition

Standard of Care Nutritional Support

Survey Administration

Receive fiber supplementation orally or enterally

Dietary Supplement

Undergo collection of blood and stool samples

Biospecimen Collection

Electronic Health Record Review

Fiber and Dietary Assessments

David Fredricks

This clinical trial examines sustained oral fiber supplementation for patients undergoing donor stem cell transplantation for hematological malignancies. Patients undergoing donor stem cell transplantation often develop oral and gastrointestinal damage from chemotherapy, radiotherapy, or graft-versus-host disease. Oral fiber nutrition support may improve overall nutrition, support a normal gut microbiome (bacteria that live in the gut) and/or improve gut function in patients undergoing stem cell transplants.

OUTLINE:

Current study design: Patients receive fiber supplementation orally (PO) or enterally starting 14 days prior to day 1 of conditioning chemotherapy and continuing until discharge Patients who are not able to receive sufficient nutrition by mouth may receive parenteral nutrition or enteral nutrition by feeding tube from the hospital. Patients may undergo blood sample collection throughout the study.

Previous study design: Before this study was amended in January 2024, patients were randomized to 1 of 2 arms.

Previous Arm I: Patients received enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge.

Previous Arm II: Patients received standard of care nutritional support.

Sustained Oral Fiber Supplementation for Patients Undergoing Donor Stem Cell Transplantation for Hematological Malignancies

Feasibility of Implementing Sustained Oral Fiber Supplementation for Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Hematological Malignancies

The proportion of eligible patients who consent to enroll in the study will be computed based on the number approached and estimated with 95% confidence intervals.

Tolerance of initiating and maintaining oral fiber intake (or via enteral nutrition) will be calculated as delivery of the intended amount on each day that nutritional supplementation was indicated.

The post-discharge questions measuring level of comfort or distress experienced with each nutritional treatment will be tabulated.

Will assess safety including diarrhea, abdominal pain, bloating.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
DRIHNC - Dehydration Reduction in Head & Neck Cancer	NCT03799380	Dehydration Head & Neck Can... Esophageal Canc...	Gatorade G2 Standard of car...	18 Years -	Case Comprehensive Cancer Center
Sustained Oral Fiber Supplementation for Patients Undergoing Donor Stem Cell Transplantation for Hematological Malignancies	NCT04829136	Hematopoietic a...	Kate Farms 1.0 Standard of Car... Survey Administ... Dietary Supplem... Biospecimen Col... Electronic Heal... Fiber and Dieta...	18 Years -	Fred Hutchinson Cancer Center
Sustained Oral Fiber Supplementation for Patients Undergoing Donor Stem Cell Transplantation for Hematological Malignancies	NCT04829136	Hematopoietic a...	Kate Farms 1.0 Standard of Car... Survey Administ... Dietary Supplem... Biospecimen Col... Electronic Heal... Fiber and Dieta...	18 Years -	Fred Hutchinson Cancer Center

Spots Global Cancer Trial Database for standard of care nutritional support