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

NCT ID: NCT06754293

Last Updated: 2024-12-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-02-01

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.

Conditions

Musculoskeletal Symptoms; Breast Cancer; Endocrine Therapy; Aromatase Inhibitors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Exercise group

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 ha

Group Type: EXPERIMENTAL

rehabilitation exercise

Intervention Type: BEHAVIORAL

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

control group

Patients in the control group will receive standard guidance related to breast cancer endocrine therapy, including general information on exercise rehabilitation for managing bone and joint symptoms. This guidance allows patients the flexibility to choose their preferred form, type, and intensity of exercise. In addition, psychological counseling and health education will be provided to support their overall well-being.

Monthly telephone follow-ups will be conducted to address concerns regarding the side effects of endocrine therapy. However, no specific exercise plans will be offered, nor will there be any monitoring or supervision of patients' adherence to exercise routines.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

rehabilitation exercise

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

Intervention Type: BEHAVIORAL

Other Intervention Names

health education

Eligibility Criteria

Inclusion Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Cancer Hospital, China

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Lingyun Jiang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Cancer Center

Shanghai, XuHui, China

Countries

China

Other Identifiers

138103810480184013133114411411

Identifier Type: -

Identifier Source: org_study_id