Locally Advanced Breast Cancer (LABC)NCT07420335
Preoperative Shoulder Exercises and Postoperative Inflammation, Pain, and Function After Modified Radical Mastectomy
A study testing Preoperative shoulder exercise and Standard preoperative care in people with Locally Advanced Breast Cancer (LABC) and Postoperative Inflammation, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Locally Advanced Breast Cancer (LABC), Postoperative Inflammation, Prehabilitation
- What is being tested?
- Preoperative shoulder exercise and Standard preoperative care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteIndonesia
- Study dates
- 21 Jan 2026to 3 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Drop out criteria:
- incomplete follow up
- Unwillingness to undergo repeated blood sampling during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia
Jakarta Pusat, Dki Jakarta, 10430
Sonar Soni Panigoro, MD, Ph.D, +62-812-9502-754, sonar.soni@ui.ac.id
Sonar Soni Panigoro, MD,Ph.D
About this study
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
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.
Read the 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.
- Being tested
- Preoperative shoulder exercise, Standard preoperative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative shoulder exerciseBehavioural
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 careOther
Participants will receive standard preoperative care without a structured shoulder exercise program prior to modified radical mastectomy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard preoperative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (preoperative), 1 day before surgery and 1 month after surgery
Secondary outcomes (1)
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.
Measured: Baseline(before intervention), 1-day preoperative and 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start21 Jan 2026 (estimated)
- Primary completion3 Oct 2026 (estimated)
- Study completion3 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Breast Cancer (LABC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Freda Susana Halim, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420335
- Sponsor's protocol ID
- 25-08-1282
- Other IDs
- KET-1375/UN2.F1/ETIK/PPM.00.02
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no formal data-sharing plan was included in the ethics-approved study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07420335
- Acronym / sponsor ID
- 25-08-1282
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 21 Jan 2026 (estimated)
- Primary completion
- 3 Oct 2026 (estimated)
- Study completion
- 3 Dec 2026 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 : Preoperative shoulder exercise | Experimental | Behavioral: Preoperative shoulder exerciseArm 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. |
| Arm 2 : Standard Preoperative Care | Other | Other: Standard preoperative careArm 2: Standard Preoperative Care Participants will receive standard preoperative care without a structured shoulder exercise program prior to modified radical mastectomy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative shoulder exerciseArm 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. | Behavioural | Arm 1 : Preoperative shoulder exercise |
| Standard preoperative careParticipants will receive standard preoperative care without a structured shoulder exercise program prior to modified radical mastectomy. | Other | Arm 2 : Standard Preoperative Care |
Primary outcome
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.
1 secondary outcome
Short Form-36 (SF-36) quality-of-life score
Time frame: Baseline(before intervention), 1-day preoperative and 1 month after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no formal data-sharing plan was included in the ethics-approved study protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative shoulder exercise and Standard preoperative care in people with Locally Advanced Breast Cancer (LABC) and Postoperative Inflammation, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Freda S Halim, MD, Ph.D (+62812-99000-530, freda.susana@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in C-reactive protein (CRP) level (time frame: Baseline (preoperative), 1 day before surgery and 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.