Trial · NCT01614990
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of Body Weight | 7 days | The change of body weight(kg)will be measured between day 1 and day (Day 7-Day 1). |
| Primary | Change of Insulin-like Growth Factor-1 (IGF-1) Plasma Levels | 7 days | The change of IGF-1 plasma levels will be measured between day 1 (prior to dosing) and day 7. |
| Primary | Change of Quality of Life Score | 7 days | The change of quality of life score (Anderson Symptom Assessment Scale \[ASAS; absolute score\], Functional Assessment of Chronic Illness-Fatigue \[FACIT-F; total score\]) will be measured between day 1 and day 7. The ASAS is a validated measure of quality of life (QOL) associated with symptom clusters commonly seen in cancer patient populations. The absolute score ranges from 0-100 with higher scores indicative of worse cancer symptoms. The FACIT-F is a validated measure of QOL associated with fatigue related to chronic illness. To account for missing items, the FACIT-F total score (sum of subscales) was adjusted by calculating the percent total score of items completed with the following: (FACIT-F Total Score)/(N items completed ×4 (maximum possible score for each item ) × 100% Scores range from 0 to 160 with higher scores indicative of greater fatigue. Tests consists of 5 subscales: Physical, Social/Family, Emotional, and Functional Well-Being, and Additional Concerns. |
| Secondary | Food Intake and Diary | 7 days | Food intake as measured by a food diary to be recorded for 3 days before days 1 and 7 and by a test meal done at screening and on day 7. |
| Secondary | Appetite (Visual Analog Scale [VAS] for Appetite) | 7 days | Change of appetite measured by a validated visual analogue scale between day 1 and day 7. The VAS is a one-item measure that quantifies subjective rating with a 100 mm line anchored at 0 mm with the words "Not at all" and at 100 mm with the word "Extremely" where the participant makes a mark on the line indicative of their current hunger level. Higher scores are indicative of greater perceived hunger. |
| Secondary | Handgrip Strength | 7 days | Change in muscle strength as measured by handgrip strength. |
| Secondary | Energy Expenditure as Measured by Indirect Calorimetry. | 7 days | Change in energy expenditure as measured by indirect calorimetry. |
| Secondary | Laboratory Assays | Day 1 to Day 7 | Change in Insulin-Like Growth Factor Binding Protein-3 (IGFBP-3), Highly Sensitive C-Reactive Protein (CRP), and glucose between day 1 and day 7. |
| Secondary | Safety Laboratory (White Blood Cells) | Day 1 to Day 7 | Change in Clinical laboratory parameters: complete blood count (CBC) |
| Secondary | ECG | Day 1 to Day 7 | Change in electrocardiogram (ECG) at days 1 and 7 before and 1 hour after dosing and on the post-study visit. |
| Secondary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 7 days | Recording of any adverse events from day 1 to day 7. |
| Secondary | Change in Stair Climbing Power (SCP) | Day 1 to Day 7 | SCP was assessed on Day 1 \& 7. Participants were asked to climb a standard flight of hospital stairs (13 steps, 15.3 cm each) as quickly as possible, using the handrail if necessary. Two-three trials were attempted with one minute of rest in-between. The shortest completion time was transformed into power and used for analysis where: W= (body mass (kg) × acceleration of gravity (9.81 m⁄s\^2 )× vertical distance (1.99 m))/(time (seconds)) |
| Secondary | Change in Percent Predicted Resting Energy Expenditure (REE) | Day 1 to Day 7 | Change in percent predicted (REE) as measured by indirect calorimetry. |
| Secondary | Change in Respiratory Quotient | Day 1 to Day 7 | Change in respiratory quotient (the ratio of volume CO2 released to volume of O2 utilized) as measured by indirect calorimetry. |
| Secondary | Laboratory Assays (Growth Hormone) | Day 1 to Day 7 | Change in Growth Hormone (GH) between day 1 and day 7. |
| Secondary | Safety Laboratory (Red Blood Cells) | Day 1 to Day 7 | Change in Clinical laboratory parameters: complete blood count (CBC) |
| Secondary | Safety Laboratory (Hemoglobin [HGB]; Mean Corpuscular Hemoglobin [MCH] Concentration; Protein; Total Albumin) | Day 1 to Day 7 | Change in Clinical laboratory parameters: complete blood count (CBC) and complete metabolic panel |
| Secondary | Laboratory Safety (Hematocrit [HCT]; Red Cell Distribution Width [RCDW]; Neutrophil; Lymphocyte; Monocyte; Eosinophil; Basophil) | Day 1 to Day 7 | Change in Clinical laboratory parameters: complete blood count (CBC) |
| Secondary | Safety Laboratory (Mean Corpuscular Volume [MCV]) | Day 1 to Day 7 | Change in Clinical laboratory parameters: complete blood count (CBC) |
| Secondary | Safety Laboratory (Mean Corpuscular Hemoglobin [MCH]) | Day 1 to Day 7 | Change in Clinical laboratory parameters: complete blood count (CBC) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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.
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