Abstract P2-13-02: Phase II Study of Glucosamine with Chondroitin on Joint Symptoms Induced by Aromatase Inhibitors in Breast Cancer Patients
Bibliographic record
Abstract
Abstract Background: Aromatase inhibitors (AIs) are commonly used as adjuvant endocrine therapy in postmenopausal women with hormone receptor-positive breast cancer (BC). However, many patients treated with AIs experience joint symptoms which may lead to non-adherence to treatment. We examined whether glucosamine plus chondroitin improves AI-induced arthralgias in women with early stage BC. Methods: This is a single-arm Phase II study evaluating the efficacy of glucosamine and chondroitin in postmenopausal BC patients with moderate to severe AI-induced arthralgias. Patients took glucosamine sulfate (1500mg/d) + chondroitin sulfate (1200mg/d) for 24 weeks, and were assessed every 6 weeks. The primary endpoint was change in Outcome Measure in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria at 24 weeks. Secondary endpoints include changes in Brief Pain/Stiffness Inventory-Short Form (BPI-SF), Western Ontario and McMaster Universities Osteoarthritis (WOMAC), Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH), quality of life, grip strength and estradiol level. A Simon two-stage design was used. If 7/22 responses were observed, the trial would continue. Results: Of 36/46 patients enrolled to date, 21 were evaluable at 24 weeks. Median age: 61 (46-80); White/Hispanic/Black/Asian: 11/5/4/1. At 24 weeks, 12/21 patients (57%) had improved pain/stiffness or function in their knees or hips, and 14/21 patients (67%) had improvement in their hands, and 80% had improvement in hands and/or knees. There were also decreases in BPI pain/stiffness severity and functional interference (P<0.05). Reassuringly, there was no increase in serum estradiol levels. Conclusion: Glucosamine and chondroitin is a well-tolerated and potentially effective treatment for AI-induced arthralgia. Evaluation of these agents in a placebo controlled phase III study is warranted. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P2-13-02.
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
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".