Evaluating the Efficacy of Structured Exercise Interventions in Alleviating Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors: A Randomized Controlled Trial
Trial ID: NCT06642948
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-10-20
Completion date: 2025-01-01
Sponsor: Fudan University
Conditions: Musculoskeletal Symptoms; Breast Cancer; Endocrine Therapy; Aromatase Inhibitors
Interventions: Motor rehabilitation based on ai visual recognition
Locations: Shanghai Cancer Center
Countries: China
Enrollment: 80
Age range: None - None
Sex: ALL

Summary:
This study aims to develop and evaluate an artificial intelligence (AI)-based skeletal recognition system designed to support real-time, interactive rehabilitation exercise (RE programs. The goal is to mitigate musculoskeletal symptoms associated with endocrine therapy in breast cancer survivors.Endocrine therapy remains a cornerstone in the treatment of hormone receptor-positive breast cancer, typically extending over 5 to 10 years. While the therapeutic benefits of endocrine therapy are well established, agents such as aromatase inhibitors frequently induce musculoskeletal symptoms (MS), including joint pain, stiffness (particularly morning stiffness), carpal tunnel syndrome, tenosynovitis, myalgia, and muscle weakness. These symptoms, which may be continuous or intermittent, can affect both central (spine, hips, shoulders) and peripheral joints (elbows, wrists, knees, feet), severely compromising patients' quality of life (QoL). Although physical exercise has been demonstrated to alleviate these symptoms, adherence to adequate exercise regimens remains suboptimal among patients. Furthermore, there is no consensus on the optimal type, duration, or intensity of exercise interventions, and standardized protocols are lacking. Recognizing exercise as a long-term behavior, we are developing a home-based, AI-assisted rehabilitation program tailored to the specific needs of patients undergoing endocrine therapy.

Eligibility criteria:
Inclusion Criteria:

* 1\. Pathologically confirmed hormone receptor-positive breast cancer (stage I, II, III).

  2\. Initiation of treatment with aromatase inhibitors (e.g., anastrozole, letrozole, exemestane).

  3\. Postmenopausal women, including those with surgically induced menopause. 4. Clear consciousness, no cognitive or communication impairments, and able to comply with the intervention.

  5\. Informed consent obtained, with voluntary participation in the study. 6. Bone and joint symptoms with a Brief Pain Inventory (BPI) score of ≥3, or presence of at least one of the following risk factors: elevated bone turnover markers, reduced vitamin D levels, increased inflammatory cytokines, elevated C-reactive protein, or elevated rheumatoid factor.

  7\. Not participating in any physical therapy or exercise-based interventions that may interfere with this study.

Exclusion Criteria:

\- 1. Recurrence of breast cancer or distant metastasis. 2. Presence of other malignancies. 3. Diagnosed rheumatoid arthritis, bone and joint trauma, or other severe bone and joint diseases.

4\. Bone mineral density T-score \<-2.5. 5. Presence of absolute contraindications to exercise.

Outcomes:
Grip strength; M-SACRAH; WOMAC; ROM