Clinical trial · Observational
Loss of Grip Strength, BMI, and Adjuvant Endocrine Therapy Breast Cancer
A Prospective Assessment of Loss of Grip Strength by Baseline BMI in Breast Cancer Patients Receiving Adjuvant Third-generation Aromatase Inhibitors and Tamoxifen
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Early stage hormone receptor positive breast cancer is typically treated with adjuvant endocrine therapy in order to decrease risk of breast cancer recurrence and to improve overall survival from the disease. Typical agents used for treatment include tamoxifen and the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is increasingly common because it is associated with fewer long-term serious toxicities compared to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which can influence adherence to therapy and can lead to treatment discontinuation in a minority of cases. The mechanism underlying development of this toxicity remains unclear, and predictors of who will develop these symptoms remain undefined. Initial reports suggest that grip strength decreases during aromatase inhibitor therapy, and that body-mass index may influence development of this symptom. Therefore, this longitudinal study has been developed to determine change in grip strength over time in women treated with aromatase inhibitors and tamoxifen, as well as to identify potential associations between change in grip strength and BMI. Patient self-reported symptoms will also be collected. A total of 115 women with early stage breast cancer who are initiating therapy with either an aromatase inhibitor or tamoxifen will be enrolled.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arthralgia | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anastrozole, letrozole, exemestane | Drug | — | UNRESOLVED |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- AI therapy
- description
- Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
- interventionNames
- Drug: anastrozole, letrozole, exemestane
- label
- Tamoxifen
- description
- Subjects who started treatment with tamoxifen
- interventionNames
- Drug: Tamoxifen
Primary outcomes (1)
- measure
- Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy
- timeFrame
- baseline and 12 months
- description
- Change in BMI between baseline and 12 months of endocrine therapy
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage 0-III breast cancer who are scheduled to receive endocrine therapy with tamoxifen or an aromatase inhibitor * All prior surgery and chemotherapy should be complete * Age 18 and above and postmenopausal Exclusion Criteria: * Major rheumatologic disorders * Concomitant sex hormone containing drugs or Leutinizing Hormone Releasing Hormone agonist therapy * For those subjects initiating treatment with an aromatase inhibitor, prior tamoxifen within 4 weeks of enrollment * For those subjects initiating treatment with tamoxifen, prior aromatase inhibitor within 4 weeks of enrollment
References
Publications (0)
Data not yet available