Preoperative Shoulder Exercises and Postoperative Inflammation, Pain, and Function After Modified Radical Mastectomy

The Effect of Preoperative Shoulder Range-of-Motion Exercises on C-Reactive Protein (CRP) Levels, Pain, and Shoulder Joint Dysfunction, as Well as Quality of Life in Patients With Locally Advanced Breast Cancer After Modified Radical Mastectomy

This study evaluates whether preoperative shoulder range-of-motion exercises influence postoperative inflammatory response, pain, shoulder function, and quality of life in patients with locally advanced breast cancer undergoing modified radical mastectomy.

Study Overview

• Status: Not yet recruiting
• Conditions: Prehabilitation; Postoperative Inflammation; Locally Advanced Breast Cancer (LABC)
• Intervention / Treatment: Behavioral: Preoperative shoulder exercise; Other: Standard preoperative care

Detailed Description

Breast cancer patients undergoing modified radical mastectomy are at risk of postoperative pain, shoulder dysfunction, and impaired quality of life, which may be associated with postoperative inflammatory responses. Preoperative rehabilitation strategies, including shoulder range-of-motion exercises, have been proposed to improve postoperative recovery, but evidence in patients with locally advanced breast cancer remains limited.

This study aims to evaluate the effects of a structured preoperative shoulder range-of-motion exercise program on postoperative inflammatory markers, specifically C-reactive protein (CRP), as well as pain intensity, shoulder joint function, and quality of life in patients with locally advanced breast cancer undergoing modified radical mastectomy.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Freda S Halim, MD, Ph.D; Phone Number: +62812-99000-530; Email: freda.susana@ui.ac.id

Study Locations

• Indonesia
  • Dki Jakarta
    • Jakarta Pusat, Dki Jakarta, Indonesia, 10430
      • Dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia
      • Contact: Sonar Soni Panigoro, MD, Ph.D; Phone Number: +62-812-9502-754; Email: sonar.soni@ui.ac.id
      • Contact: Sonar Soni Panigoro, MD,Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients with clinically locally advanced breast cancer (stage IIIA-IIIC according to the American Joint Committee on Cancer staging system) who have been scheduled to undergo modified radical mastectomy.
• Age ≥ 18 years at the time of diagnosis
• Willing to undergo preoperative rehabilitation for 6-8 weeks and to perform the recommended home-based exercise program.
• Willing to participate in follow-up via telephone.

Exclusion Criteria:

• Inability to understand verbal or written communication, resulting in difficulty following exercise instructions.
• Intraoperative complications, such as injury to or transection of the thoracodorsal nerve, long thoracic nerve, and/or intercostobrachial nerve.
• Postoperative complications leading to delayed wound healing, defined as incomplete wound healing at one month after surgery, including wound dehiscence, wound infection, or abscess formation.
• Pre-existing shoulder joint motion limitation diagnosed prior to surgery (e.g., preoperative frozen shoulder).
• Presence of inflammatory conditions in other body regions at the start of or during the study that may result in elevated leukocyte counts, such as diarrhea, urinary tract infection, or skin infection.
• Requirement for nonsteroidal anti-inflammatory drugs (NSAIDs) or systemic corticosteroids for the management of inflammation.

Drop out criteria:

• incomplete follow up
• Unwillingness to undergo repeated blood sampling during the study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 : Preoperative shoulder exercise; Arm 1: Preoperative Shoulder Exercise Participants will receive a structured preoperative shoulder range-of-motion exercise program prior to modified radical mastectomy, in addition to standard preoperative care.	Behavioral: Preoperative shoulder exercise; Arm 1 : Participants in the intervention arm will perform a structured preoperative shoulder range-of-motion exercise program prior to modified radical mastectomy. The exercises are designed to maintain shoulder mobility and are conducted in addition to standard preoperative care.
Other: Arm 2 : Standard Preoperative Care; Arm 2: Standard Preoperative Care Participants will receive standard preoperative care without a structured shoulder exercise program prior to modified radical mastectomy.	Other: Standard preoperative care; Participants will receive standard preoperative care without a structured shoulder exercise program prior to modified radical mastectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in C-reactive protein (CRP) level	C-reactive protein (CRP) levels will be measured to assess the postoperative inflammatory response in patients undergoing modified radical mastectomy.	Baseline (preoperative), 1 day before surgery and 1 month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form-36 (SF-36) quality-of-life score	The Short Form-36 (SF-36) questionnaire will be used to evaluate health-related quality of life.	Baseline(before intervention), 1-day preoperative and 1 month after surgery

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Estimated): January 21, 2026
• Primary Completion (Estimated): October 3, 2026
• Study Completion (Estimated): December 3, 2026

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 25-08-1282; KET-1375/UN2.F1/ETIK/PPM.00.02 (Registry Identifier: Ethical Approval from Universitas Indonesia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because no formal data-sharing plan was included in the ethics-approved study protocol.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No