Clinical trial NCT06642948: AI-based Skeleton Recognition System for Rehabilitation Exercise in Breast Cancer Survivors: A Randomized Controlled Trial
Official title: Evaluating the Efficacy of Structured Exercise Interventions in Alleviating Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Musculoskeletal Symptoms
Breast Cancer
Endocrine Therapy
Aromatase Inhibitors
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Primary outcomes:
measure: Grip strength
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: M-SACRAH
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: WOMAC
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: ROM
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: BCTQ
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: CRP
timeFrame: Baseline and 3 months
measure: rheumatoid factor
timeFrame: Baseline and 3 months
measure: 25-hydroxyvitamin D
timeFrame: Baseline and 3 months
measure: IL-1、INF-a、IL-6、IFN-a、IFN-Y
timeFrame: Baseline and 3 months
measure: Bone mineral density
timeFrame: baseline
measure: OPG/RANKLE SNP
timeFrame: baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Cancer Center
Study officials:
References: