NCT06642948 AI-based Skeleton Recognition System for Rehabilitation Exercise in Breast Cancer Survivors: A Randomized Controlled Trial
| NCT ID | NCT06642948 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | Musculoskeletal Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-10-20 |
| Primary Completion | 2025-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-10-20 with a primary completion date of 2025-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06642948 clinical trial?
This trial is open to participants of all sexes, studying Musculoskeletal Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06642948 currently recruiting?
Yes, NCT06642948 is actively recruiting participants. Contact the research team at 22211170029@m.fudan.edu.cn for enrollment information.
Where is the NCT06642948 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06642948 clinical trial?
NCT06642948 is sponsored by Fudan University. The trial plans to enroll 80 participants.