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Dietary Supplement

Survey Administration for Blood Cancers

N/A

Recruiting

Led By David Fredricks

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Planned myeloablative allogeneic stem cell transplantation (note, melphalan dose of 140 mg/m^2 is included) with planned hospital admission for transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at consenting

Awards & highlights

Study Summary

This trial is examining if early enteral nutrition (through a feeding tube) is better than parenteral (intravenous) nutrition for patients undergoing a stem cell transplant for cancer.

Who is the study for?

This trial is for adults who are about to have a stem cell transplant for blood cancer and will be hospitalized for it. They must understand the study and agree to participate. People with major uncontrolled psychiatric issues, those already on tube or IV nutrition, or with physical barriers to nasal feeding tubes can't join.Check my eligibility

What is being tested?

The study is testing if giving nutritional support through a nose-to-gut feeding tube early on helps patients better tolerate their stem cell transplant compared to standard care. It includes using Kate Farms formula and tracking patient experiences via surveys.See study design

What are the potential side effects?

Tube feeding may cause discomfort, nasal irritation, digestive problems like nausea or diarrhea, and potential complications from tube placement. Standard care side effects depend on the usual treatments given during transplantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for a stem cell transplant that will require a hospital stay.

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I am scheduled for a stem cell transplant that requires a hospital stay.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 90 days following transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 90 days following transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days following transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Study participation rates

Secondary outcome measures

Incidence of adverse events

Level of comfort/distress attributed to initiating and maintaining oral fiber intake

Number of days receiving at least 10 grams of fiber

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Supportive care (Fiber) [Current study activity]Experimental Treatment5 Interventions

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.

Group II: Arm I (enteral nutrition) [Discontinued in January 2024]Experimental Treatment2 Interventions

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

Group III: Arm II (standard of care) [Discontinued in January 2024]Active Control2 Interventions

Patients receive standard of care nutritional support.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dietary Supplement

2022

Completed Phase 2

~250

Biospecimen Collection

2004

Completed Phase 2

~1730

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor

443 Previous Clinical Trials

148,215 Total Patients Enrolled

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,343,238 Total Patients Enrolled

David FredricksPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

1 Previous Clinical Trials

72 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots in this research endeavor for potential participants?

"This clinical trial, which was originally listed on June 22nd 2022, is currently recruiting patients. The research team last modified the posting on September 8th 2022."

Answered by AI

How many participants are eligible for acceptance into this medical study?

"Agreed. According to clinicaltrials.gov, this experiment is actively recruiting from June 22nd 2022 and necessitates 30 subjects across 1 facility. The posting was last adjusted on September 8th, 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Sustained Oral Fiber Supplementation for Patients Undergoing Donor Stem Cell Transplantation for Hematological Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04829136.