Trial · NCT06175273
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Body Composition | Baseline, at 3 and 6 months after baseline | Change in quadriceps muscle layer thickness is measured by ultrasound and reported as change from baseline in centimeters. |
| Primary | Change in Body Composition Mid-Upper Arm | Baseline, at 3 and 6 months after baseline | Change in body composition will be measured by mid-upper arm circumference and will be measured in centimeters. |
| Secondary | Participants With Intervention Intolerances | Randomization through end of treatment (6 months) | Intervention intolerances were assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) to determine toxicity grade. |
| Secondary | Change in Weight | Baseline, at 3 and 6 months after baseline | Weight will be measured in kilograms (kg). |
| Secondary | Change in Body Mass Index (BMI) | Baseline, at 3 and 6 months after baseline | Body Mass Index (BMI) will be calculated using weight in pounds (lb) and height in inches (in). |
| Secondary | Change in Biomarker IL-6 | Baseline, at 3 and 6 months after baseline | IL-6 concentrations were measured from blood samples collected via central venous lines. |
| Secondary | Change in Biomarker Leptin | Baseline, at 3 and 6 months after baseline | Leptin concentrations were measured from blood samples collected via central venous lines. |
| Secondary | Change in Total Cholesterol | Baseline, at 3 and 6 months after baseline | Total cholesterol concentrations were measured from blood samples collected via central venous lines. |
| Secondary | Change in Cystatin-C | Baseline, at 3 and 6 months after baseline | Cystatin-C concentrations were measured from blood samples collected from blood samples collected via central venous lines. |
| Secondary | Change in Physical Activity | Baseline, at 3 and 6 months after baseline | Physical activity was assessed using the Lanksy Play-Performance Scale, a measure of Pediatric Functional Status based on parent descriptions of the child's activity and response to treatment. Scores ranges from 0-100, with higher scores indicating greater physical activity and functional status. Results are reported as the change from baseline to each follow-up assessment. |
| Secondary | Tube Feeding Compliance | From randomization through 3 months after randomization | Tube feeding compliance was assessed weekly by comparing the self-reported tube feeding volume (mL) with the prescribed tube feeding volume (mL). Results are reported as the change in volume relative to the prescribed amount. |
| Secondary | Oral Nutrition Supplements Compliance | From randomization through 3 months after randomization | Compliance with prescribed oral nutrition supplements was assessed based on the amount of oral nutrition supplement (ONS) consumed compared with the prescribed amount. ONS was prescribed as 8 oz per dose at least once daily, depending on estimated nutrient needs. Percent compliance represents the amount of ONS consumed relative to the prescribed amount over the assessment period. |
| Secondary | Percentage of Participants Who Were Medication Compliant | From randomization through 3 months after randomization | Medication compliance will be analyzed by self-reported weekly medication use during the period from randomization through 3 months after randomization. Overall compliance for the 3-month period will be calculated based on the number of days prescribed medications were taken as directed compared with the number of days medications were taken less than prescribed. |
| Secondary | Days Hospitalized for Nutrition-Related Issues | Baseline through 6 months for control group. Randomization through 3 months for intervention group. | The total number of days hospitalized for nutrition-related issues during the assessment period, as determined by review of the participant's medical record for hospitalizations related to nutritional status or nutrition-related complications. |
| Secondary | Number of Clinic Visits for Nutrition-Related Issues | Baseline through 6 months for control group. From randomization through 3 months for intervention groups. | The total number of clinic visits for nutrition-related issues during the assessment period, as determined by review of the participant's medical record for hospitalizations related to nutritional status or nutrition-related complications. |
| Secondary | Number of Participants With Malnutrition Diagnosis | Baseline through 6 months for control group. Randomization through 3 months for intervention group. | The number of participants with a malnutrition diagnosis during the assessment period, as documented in the study assessment. The data table reports the number of participants with a malnutrition diagnosis (yes responses). |
| Secondary | Number of Participants With Relapse or Disease Progression | Baseline through 6 months for control group. Randomization through 3 months for intervention group. | The number of participants with relapse or disease progression during the assessment period. The data table reports the number of participants with relapse or disease progression (yes responses). |
| Secondary | Number of Days That Cancer Treatment is Put on Hold | Baseline through 6 months for control group. Randomization through 3 months for intervention group. | The total number of days that cancer treatment was put on hold during the assessment period, as determined by review of the participant's medical record for hospitalizations related to nutritional status or nutrition-related complications. |
| Secondary | CTCAE Toxicity Grade | Baseline through 6 months for control group. Randomization through 3 months for intervention group. | Treatment-related toxicities were assessed using the Common Terminology Criteria for Adverse Events (CTCAE) grading scale (Grades 1-4). Higher grades indicate more severe toxicity. All participants were assessed for treatment-related toxicities during the assessment period. No participants experienced treatment-related toxicities. |
| Secondary | Cancer Diagnosis Type | Baseline through 6 months for control group. Randomization through 3 months for intervention group. | These measurements will include the diagnosis type (cancer type). |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06175273/registered