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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-06448 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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The goal of this research study is to learn if feeding someone after a stem cell transplant is safe and practical.
Primary Objective:
a. To determine the feasibility, acceptability, and safety of NG tube feeding compared with patients not electing NG tube feeding.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enteral nutrition (EN)-Group 1 | Experimental | Participants will receive enteral feeding (directly into the stomach) based on your ability to receive your daily caloric needs by mouth. Participants will be monitored by a dietician and may receive feeding by vein to achieve caloric goals. |
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| Standard care parenteral nutrition (PN)-Group 2 | Active Comparator | Participants will receive the standard of care. Participants will be monitored by a dietician to see if the participants are able to receive your daily caloric needs by mouth. Some participants may be able to receive oral dietary supplements, but if this is not possible or not enough, participants will begin receiving standard of care feeding by vein. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteral nutrition (EN) | Dietary Supplement | Given by Nasogastric Tube |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | through study completion; an average of 1 year. |
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Inclusion Criteria:
Have plans to be admitted or be admitted to an inpatient pediatric or adult ward for the purpose of HSCT.
Be greater than 2 years of age and less than 25 years of age at time of study enrollment.
Participants > 18 or guardians for participants < 18 are willing and able to give written informed consent and to comply with all of the study activities. Assent is required for children > 7 years old.
a) Participants must be English, Italian, Chinese/Mandarin, or Spanish speaking
Participants will be encouraged to co-enroll on two additional related energy -balance protocols (highly encouraged but not required)
Participants will be asked to consider co-enrollment on Stem Cell Registry study (not required):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shehla Razvi, MD | Contact | (713) 792-6635 | srazvi@mdanderson.org | |
| Karen Moody, MD | Contact | 713-792-6610 | kmoody@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Shehla Razvi, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| Standard care parenteral nutrition (PN) |
| Other |
Given by PO or Given by IV (vein) |
|
| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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