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

NCT07420335 | Not Yet Recruiting DMC

• 2 other identifiers: 25-08-1282KET-1375/UN2.F1/ETIK/PPM.00.02
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Locally Advanced Breast Cancer (LABC); Postoperative Inflammation; Prehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Short Form-36 (SF-36) quality-of-life score

  Baseline(before intervention), 1-day preoperative and 1 month after surgery

Study Arms (2)

Arm 1 : Preoperative shoulder exercise

EXPERIMENTAL

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 2 : Standard Preoperative Care

OTHER

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

Interventions

Preoperative shoulder exercise BEHAVIORAL

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.

Arm 1 : Preoperative shoulder exercise

Standard preoperative care OTHER

Participants will receive standard preoperative care without a structured shoulder exercise program prior to modified radical mastectomy.

Arm 2 : Standard Preoperative Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: This study includes female patients diagnosed with locally advanced breast cancer undergoing modified radical mastectomy.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia

Jakarta Pusat, Dki Jakarta, 10430, Indonesia

Location

Central Study Contacts

Freda S Halim, MD, Ph.D

CONTACT

+62812-99000-530; freda.susana@ui.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Oncology Trainee

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: January 21, 2026
• Primary Completion (Estimated): October 3, 2026
• Study Completion (Estimated): December 3, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)