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Not yet recruiting NCT07420335

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

No phase Interventional Locally Advanced Breast Cancer (LABC) Postoperative Inflammation Prehabilitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Preoperative shoulder exercise, Standard preoperative care.
Who it may be relevant to
Registry conditions: Locally Advanced Breast Cancer (LABC), Postoperative Inflammation, Prehabilitation. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Change in C-reactive protein (CRP) level [Time frame: Baseline (preoperative), 1 day before surgery and 1 month after surgery]
Secondary outcome measures (1)
  • Short Form-36 (SF-36) quality-of-life score [Time frame: Baseline(before intervention), 1-day preoperative and 1 month after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Indonesia · 1 center
  • Dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia — Jakarta Pusat

Identifiers

NCT: NCT07420335 · 25-08-1282 · KET-1375/UN2.F1/ETIK/PPM.00.02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗