Neoplasms

Blood and Lymph Conditions

All 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	Link
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 fiber and dietary assessments