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

ConditionsLocally Advanced Breast Cancer (LABC)Postoperative Inflammation Prehabilitation

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-70

SponsorIndonesia University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

52 Participants

are divided into 2 treatment groups

Group A: Arm 1 : Preoperative shoulder exerciseExperimental treatment 1 intervention

Group B: Arm 2 : Standard Preoperative CareOther 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

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.

Time frame

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

Sponsors and contacts

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Indonesia University

Lead sponsor

Fakultas Kedokteran Universitas Indonesia

Sponsor institution

Source ClinicalTrials.gov

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