A randomized placebo-controlled trial of testosterone replacement for fatigue in male hypogonadic patients with advanced cancer.
Bibliographic record
Abstract
TPS238 Background: Advanced cancer patients frequently identify fatigue as the main impairment to quality of life. Fatigue can stem from multiple causes, encompassing physical and psychosocial domains.Prior studies show a high prevalence of hypogonadism in males with cancer, particularly those on opioid therapy. Low testosterone levels correlated with fatigue, depression, poor appetite, insomnia and decreased libido. Currently there are few effective therapies for cancer related fatigue. Symptomatic hypogonadic male patients may benefit from testosterone replacement. Methods: A multicenter randomized double-blind placebo controlled trial. Treatment: Gluteal injections of 150 or 200 mg (weight based) testosterone enanthate or placebo (sesame seed oil) at baseline, day 15, 29, 43 and 57. Objectives: Primary objective is whether the decrease in fatigue from baseline to day 29 in patients who received testosterone replacement is greater than placebo as measured by a standardized questionnaire, the Functional Assessment of Chronic Illness Therapy-Fatigue subscale. Secondary objectives are the effect of testosterone replacement therapy on depression (Hospital Anxiety and Depression Scale), low sexual desire (Sexual Desire Inventory) and anorexia/cachexia (Functional Assessment of Anorexia/Cachexia Treatment scale). Functional outcomes include spontaneous activity (actigraphy), strength (handgrip) and endurance (6 minute walk). Laboratory correlates include C-reactive protein levels and serum cytokines. Eligibility criteria include male patients with advanced cancer (metastatic or locally recurrent), bioavailable testosterone < 70 ng/dL., Edmonton Symptom Assessment System fatigue score > 3 (0 to 10 scale), Prostatic Specific Antigen (PSA) <4.0 ng/mL, hemoglobin ≥9 g/dL. Patients are excluded if they have prostate cancer, severe benign prostatic hypertrophy, breast cancer, untreated obstructive sleep apnea, Class IV heart failure, thyroid disease. Current enrollment is 22 of a planned 126 patients. (NCT00965341)
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.014 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".