Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07420335

Preoperative Shoulder Exercises and Postoperative Inflammation, Pain, and Function 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia

Jakarta Pusat, Dki Jakarta, 10430, Indonesia

Location contact

Sonar Soni Panigoro, MD, Ph.D

CONTACT

[email protected]

+62-812-9502-754

Sonar Soni Panigoro, MD,Ph.D

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Change in C-reactive protein (CRP) level

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

    C-reactive protein (CRP) levels will be measured to assess the postoperative inflammatory response in patients undergoing modified radical mastectomy.

Secondary outcomes

  1. Short Form-36 (SF-36) quality-of-life score

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

    The Short Form-36 (SF-36) questionnaire will be used to evaluate health-related quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Freda S Halim, MD, Ph.D

CONTACT

[email protected]

+62812-99000-530

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.