Breast Cancer FemaleNCT06459245
Resistance Training to Prevent Lymphedema After Breast Cancer Surgery Randomized Controlled Study
A study testing Resistance training in people with Breast Cancer Female, run by Yue WANG at 1 site in China.
Trial summary
Breast cancer-related lymphedema is one of the most common chronic complications of breast cancer survivors. In existing studies, the reported incidence of lymphedema ranges from 2.5% to 42.9% . At present, there is no cure for lymphedema. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2024to 24 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- It was first diagnosed as grade I to III unilateral breast cancer by pathological examination； Breast cancer surgery was completed and axillary lymph node dissection was performed; To receive postoperative adjuvant treatment and follow-up in the outer fourth ward; Be able to communicate and exchange normally; Volunteer to participate in this research
Who cannot join
- Extreme fatigue, severe anemia, ataxia, etc.; The presence of upper limb or shoulder problems from breast cancer treatment; Edema is in a non-stable stage (stable stage of edema means no treatment for edema in the past 3 months; No inflammation of the upper extremities requiring anti-infective treatment; No change in daily activities; Limb circumference change < 10%) ； Limited limb movement due to trauma, shoulder periarthritis, etc.; Limb braking is required for health reasons. Patients are lost to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Breast cancer-related lymphedema is one of the most common chronic complications of breast cancer survivors. In existing studies, the reported incidence of lymphedema ranges from 2.5% to 42.9% . At present, there is no cure for lymphedema. Resistance training has been proved by many studies to alleviate the symptoms of lymphedema, improve the muscle strength of the upper limbs of patients, and improve the quality of life of patients, while not worsening lymphedema. Based on the best evidence, this study intends to construct resistance appropriate for this clinical scenario Training program: Conduct 3-month intervention for patients after breast cancer surgery to explore the effect of resistance training on the grip strength of the affected limb, the range of motion of the shoulder joint of the affected limb, the occurrence of lymphedema of the affected limb, quality of life, etc.
- Conditions
- Breast Cancer Female
- Being tested
- Resistance training
- Keywords
- Breast cancer, resistance training, lymphedema, randomized control
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingBehavioural
Bend the dumbbell, holding one dumbbell in each hand, on the side of the body, bend the arm to lift the dumbbell, front wall and upper arm as close as possible, pause for a moment, and then slowly lower the dumbbell until both arms are completely straight The second section of the dumbbell side flat, straight back, feet standing, arms perpendicular to the side of the body, hands grasp the dumbbell, to the side above the shoulder level, elbow slightly bent, and then put back in place The third section of the dumbbell rowing, feet stand straight, hold the dumbbell, the arm as far back as possible, can feel the upper arm and the waist back is stretched, and then straight back into the preparatory position Section 4: Lift the dumbbell flat in front of you, with your feet open, hold the dumbbell with both hands, extend your arms naturally in front of you, lift the dumbbell to the elbow above shoulder height, stay for 1-2 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Routine rehabilitation training | No intervention | Starting from the first day after surgery, progressive progress was carried out according to the functional exercise table of the affected limb in the ward Functional exercise of affected limb; Pneumatic pressure pump physiotherapy during hospitalization: once a day, 30min each time; |
| Resistance training | Experimental | Bend the dumbbell, hold a dumbbell in each hand, put it on the side of the body, bend the arm to lift the dumbbell, the front wall and the upper arm as close as possible; Hold the dumbbells flat on the side, with the back straight, stand with feet, arms perpendicular to the side of the body, hold the dumbbells with both hands, and lift the dumbbells to the side above shoulder level, elbows slightly bent; Stand with your feet straight, hold the dumbbells, and extend your arms back as far as possible. You can feel your upper arms and lower back being stretched. With your feet open, hold the dumbbells with both hands and extend your arms naturally in front of you. Lift them up until your elbows are above shoulder height and hold for 1-2 seconds.The training frequency is 2 to 3 times a week, 2 to 3 sets each time Receives: Behavioral: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphedema occurrence
Tissue and local edema due to obstruction of lymphatic drainage
Measured: 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start18 Jun 2024
- Primary completion30 Oct 2024
- Study completion24 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yue WANG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yue WANG, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459245
- Sponsor's protocol ID
- 2023SF23
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Training to Prevent Lymphedema After Breast Cancer Surgery Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06459245
- Acronym / sponsor ID
- 2023SF23
- Conditions
- Breast Cancer Female
- Keywords
- Breast cancer, resistance training, lymphedema, randomized control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yue WANGUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 24 Jun 2025 (estimated)
- First posted
- 14 Jun 2024 (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.
Breast cancer-related lymphedema is one of the most common chronic complications of breast cancer survivors. In existing studies, the reported incidence of lymphedema ranges from 2.5% to 42.9% . At present, there is no cure for lymphedema. Resistance training has been proved by many studies to alleviate the symptoms of lymphedema, improve the muscle strength of the upper limbs of patients, and improve the quality of life of patients, while not worsening lymphedema. Based on the best evidence, this study intends to construct resistance appropriate for this clinical scenario Training program: Conduct 3-month intervention for patients after breast cancer surgery to explore the effect of resistance training on the grip strength of the affected limb, the range of motion of the shoulder joint of the affected limb, the occurrence of lymphedema of the affected limb, quality of life, etc.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine rehabilitation training | No intervention | –Starting from the first day after surgery, progressive progress was carried out according to the functional exercise table of the affected limb in the ward Functional exercise of affected limb; Pneumatic pressure pump physiotherapy during hospitalization: once a day, 30min each time; |
| Resistance training | Experimental | Behavioral: Resistance trainingBend the dumbbell, hold a dumbbell in each hand, put it on the side of the body, bend the arm to lift the dumbbell, the front wall and the upper arm as close as possible; Hold the dumbbells flat on the side, with the back straight, stand with feet, arms perpendicular to the side of the body, hold the dumbbells with both hands, and lift the dumbbells to the side above shoulder level, elbows slightly bent; Stand with your feet straight, hold the dumbbells, and extend your arms back as far as possible. You can feel your upper arms and lower back being stretched. With your feet open, hold the dumbbells with both hands and extend your arms naturally in front of you. Lift them up until your elbows are above shoulder height and hold for 1-2 seconds.The training frequency is 2 to 3 times a week, 2 to 3 sets each time |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- It was first diagnosed as grade I to III unilateral breast cancer by pathological examination； Breast cancer surgery was completed and axillary lymph node dissection was performed; To receive postoperative adjuvant treatment and follow-up in the outer fourth ward; Be able to communicate and exchange normally; Volunteer to participate in this research
Key exclusion criteria (1 listed)
- Extreme fatigue, severe anemia, ataxia, etc.; The presence of upper limb or shoulder problems from breast cancer treatment; Edema is in a non-stable stage (stable stage of edema means no treatment for edema in the past 3 months; No inflammation of the upper extremities requiring anti-infective treatment; No change in daily activities; Limb circumference change < 10%) ； Limited limb movement due to trauma, shoulder periarthritis, etc.; Limb braking is required for health reasons. Patients are lost to follow-up
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 |
|---|---|---|
| Resistance trainingBend the dumbbell, holding one dumbbell in each hand, on the side of the body, bend the arm to lift the dumbbell, front wall and upper arm as close as possible, pause for a moment, and then slowly lower the dumbbell until both arms are completely straight The second section of the dumbbell side flat, straight back, feet standing, arms perpendicular to the side of the body, hands grasp the dumbbell, to the side above the shoulder level, elbow slightly bent, and then put back in place The third section of the dumbbell rowing, feet stand straight, hold the dumbbell, the arm as far back as possible, can feel the upper arm and the waist back is stretched, and then straight back into the preparatory position Section 4: Lift the dumbbell flat in front of you, with your feet open, hold the dumbbell with both hands, extend your arms naturally in front of you, lift the dumbbell to the elbow above shoulder height, stay for 1-2 seconds. | Behavioural | Resistance training |
Primary outcome
Lymphedema occurrence
Time frame: 3 months after intervention
Tissue and local edema due to obstruction of lymphatic drainage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer Female
Recruiting
Decision Support for Chemoprevention
Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Breast Cancer Female, run by Yue WANG at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Jun 2025. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphedema occurrence (time frame: 3 months after intervention). 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 3 Jun 2025.