Clinical trial NCT06754293: Evaluating the Efficacy of Structured Exercise Interventions in Alleviating Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors: a Pilot Study Protocol
Official title: Evaluating the Efficacy of Structured Exercise Interventions in Alleviating Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors: a Pilot Study Protocol
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Musculoskeletal Symptoms
Breast Cancer
Endocrine Therapy
Aromatase Inhibitors
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Cancer Hospital, China
First posted: 2024-12-31
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Endocrine therapy represents a foundational approach for managing hormone receptor-positive breast cancer, with treatment typically spanning 5 to 10 years. Although its clinical efficacy is well-established, medications like aromatase inhibitors frequently result in musculoskeletal (MS) complications, such as joint discomfort, stiffness (especially in the morning), carpal tunnel syndrome, tenosynovitis, myalgia, and reduced muscle strength. These issues, which can manifest intermittently or persistently, impact both central joints (spine, hips, shoulders) and peripheral ones (elbows, wrists, knees, feet), thereby substantially diminishing patients' quality of life (QoL). Evidence suggests that physical activity can mitigate these symptoms; however, adherence to exercise routines remains insufficient. Moreover, there is no agreement regarding the most effective type, intensity, or duration of exercise, and standardized guidelines are absent. Acknowledging the need for exercise as a sustainable habit, this research aims to design a home-based rehabilitation program customized for individuals 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.

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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: WOMAC
timeFrame: Baseline and 1month
measure: Grip strength
timeFrame: Baseline and 1month
measure: M-SACRAH
timeFrame: Baseline and 1month
measure: BCTQ
timeFrame: Baseline and 1month
measure: Range of Motion
timeFrame: Baseline and 1month
Secondary outcomes:
Other outcomes:
Locations:
city: ShangHai
country: China
facility: Shanghai Cancer Center
state: XuHui
Study officials:
References: