Evaluating the Efficacy of Structured Exercise Interventions in Alleviating Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors: a Pilot Study Protocol

N/AActive Not RecruitingNCT06754293

Fudan University24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Musculoskeletal Symptoms Breast Cancer

Interventions

rehabilitation exerciseBEHAVIORAL

The intervention group will participate in a home-based exercise program alongside standard rehabilitation guidance. Patients will receive exercise materials developed by the intervention team, along with a detailed explanation of the program, including its components, specific exercises, and expected benefits. The exercise program focuses on aerobic warm-ups and functional training, targeting key areas such as the hands, arms, shoulders, hips, legs, and back. It is designed to meet the rehabilitation needs of breast cancer patients undergoing endocrine therapy after surgery, addressing their unique challenges and enhancing recovery. The intervention team, composed of specialists in breast cancer treatment, rehabilitation therapists, nursing experts, and methodologists, has created a professional exercise guidance manual. This manual provides detailed descriptions of exercise types, specific methods, and safety precautions. To ensure effective implementation, instructional videos have

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Primary Outcomes

WOMAC

Developed in 1988 by Bellamy and Buchanan, the WOMAC index evaluates pain, stiffness, and physical function in knee or hip osteoarthritis patients over the past 48 hours . The WOMAC 3.1 version contains 24 items scored using either a VAS (0-100 mm) or a 5-point Likert scale (0-4). This study will use the VAS version, with pain (5 items, 0-500 points), stiffness (2 items, 0-200 points), and physical function (17 items, 0-1700 points) subscales. Total scores range from 0 to 2400, with higher scores indicating greater symptom burden. Scores below 800 denote mild symptoms, 800-1200 moderate, and above 1200 severe symptoms.