Evaluating the Efficacy of Structured Exercise Interventions in Alleviating Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Lingyun Jiang
22211170029@m.fudan.edu.cn
(+86) 18359374969
Time Frame
Start Date: 2024-10-20
Estimated Completion Date: 2025-01-01
Participants
Target number of participants: 80
Treatments
Experimental: Exercise group
Patients in the intervention group will engage in a home-based exercise program in addition to standard rehabilitation guidance.
No_intervention: Control group
Patients will receive guidance on breast cancer endocrine therapy-related knowledge, including exercise rehabilitation for bone and joint symptoms (including the freedom to choose the form, type, and intensity of exercise), psychological counseling, and health education.
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov

Similar Clinical Trials