| Primary | Number of Participants With Grade 3 or Higher Diarrhea GI Toxicity | Evaluation will made using Fisher's exact test. Among 99 participants who received some intervention | Only 17 participants met the protocol definition of compliance | Posted | | Count of Participants | | Participants | | 14 days | | | | ID | Title | Description |
|---|
| OG000 | Enterade | Participants who received Enterade | | OG001 | Placebo | Participants who received placebo |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Secondary | Maximum Daily Stool Frequency | | Only 17 participants met the protocol definition of compliance | Posted | | Mean | Full Range | number of stools per day | | 14 days | | | | ID | Title | Description |
|---|
| OG000 | Enterade | Participants who took Enterade | | OG001 | Placebo | Participants who took placebo |
| |
| Secondary | Percentage of Participants With Diarrhea on the Day of Maximum Daily Stool Frequency | | Only 17 participants met the protocol definition of compliance | Posted | | Count of Participants | | Participants | | 14 days | | | | ID | Title | Description |
|---|
| OG000 | Enterade | Participants who took Enterade | | OG001 | Placebo | Participants who took Placebo |
| |
| Secondary | Duration Of Hospitalization (Days) From Admission To Discharge | | Only 17 participants met the protocol definition of compliance | Posted | | Median | Full Range | days | | Up to 45 days | | | | ID | Title | Description |
|---|
| OG000 | Enterade and Standard Supportive Care |
- Two 8 oz. bottles of Enterade will be administered daily
- Enterade will be given orally from admission until day +14 or until discharge
- Standard Supportive Care will be administered according to institution's practice
Enterade Standard Supportive Care | | OG001 | Placebo and Standard Supportive Care |
- Two 8 oz. bottles of Placebo will be administered daily
- Placebo will be given orally from admission until day +14 or until discharge
- Standard Supportive Care will be administered according to institution's practice
Placebo Standard Supportive Care |
| |
| Secondary | Percent Change in Weight From Baseline to Day 14 | | Only 17 participants met the protocol definition of compliance | Posted | | Median | Full Range | percent change | | baseline and day 14 | | | | ID | Title | Description |
|---|
| OG000 | Enterade and Standard Supportive Care |
- Two 8 oz. bottles of Enterade will be administered daily
- Enterade will be given orally from admission until day +14 or until discharge
- Standard Supportive Care will be administered according to institution's practice
Enterade Standard Supportive Care | | OG001 | Placebo and Standard Supportive Care |
- Two 8 oz. bottles of Placebo will be administered daily
- Placebo will be given orally from admission until day +14 or until discharge
- Standard Supportive Care will be administered according to institution's practice
Placebo Standard Supportive Care |
| |
| Secondary | Median Amount Of Anti-Diarrheal Medications | | | Posted | | Median | Full Range | mg | | 14 days | | | | ID | Title | Description |
|---|
| OG000 | Enterade and Standard Supportive Care |
- Two 8 oz. bottles of Enterade will be administered daily
- Enterade will be given orally from admission until day +14 or until discharge
- Standard Supportive Care will be administered according to institution's practice
Enterade Standard Supportive Care | | OG001 | Placebo and Standard Supportive Care |
- Two 8 oz. bottles of Placebo will be administered daily
- Placebo will be given orally from admission until day +14 or until discharge
- Standard Supportive Care will be administered according to institution's practice
Placebo Standard Supportive Care |
| |
| Secondary | the Tolerability of Enterade® as Measured by the Number of Compliant Patients | | Patients who take the study drug two 8 oz. bottles (480 ml) daily for at least 11 days are regarded as compliant. Compliance is assessed among patients who received any amount of the study drug (N=99).Only 17 participants met the protocol definition of compliance | Posted | | Count of Participants | | Participants | | 14 days | | | | ID | Title | Description |
|---|
| OG000 | Enterade and Standard Supportive Care |
- Two 8 oz. bottles of Enterade will be administered daily
- Enterade will be given orally from admission until day +14 or until discharge
- Standard Supportive Care will be administered according to institution's practice
Enterade Standard Supportive Care | | OG001 | Placebo and Standard Supportive Care |
- Two 8 oz. bottles of Placebo will be administered daily
- Placebo will be given orally from admission until day +14 or until discharge
- Standard Supportive Care will be administered according to institution's practice
Placebo Standard Supportive Care |
| |
| Secondary | Calorie Consumption | | Only 17 participants met the protocol definition of compliance | Posted | | Median | Full Range | calories | | 14 days | | | | ID | Title | Description |
|---|
| OG000 | Enterade and Standard Supportive Care |
- Two 8 oz. bottles of Enterade will be administered daily
- Enterade will be given orally from admission until day +14 or until discharge
- Standard Supportive Care will be administered according to institution's practice
Enterade Standard Supportive Care | | OG001 | Placebo and Standard Supportive Care |
- Two 8 oz. bottles of Placebo will be administered daily
- Placebo will be given orally from admission until day +14 or until discharge
- Standard Supportive Care will be administered according to institution's practice
Placebo Standard Supportive Care |
| |
| Secondary | Number of Participants With Fever or Neutropenia | | Only 17 participants met the protocol definition of compliance | Posted | | Count of Participants | | Participants | | 14 days | | | | ID | Title | Description |
|---|
| OG000 | Enterade and Standard Supportive Care |
- Two 8 oz. bottles of Enterade will be administered daily
- Enterade will be given orally from admission until day +14 or until discharge
- Standard Supportive Care will be administered according to institution's practice
Enterade Standard Supportive Care | | OG001 | Placebo and Standard Supportive Care |
- Two 8 oz. bottles of Placebo will be administered daily
- Placebo will be given orally from admission until day +14 or until discharge
- Standard Supportive Care will be administered according to institution's practice
Placebo Standard Supportive Care |
| |