Breast CancerSTRONG-BNCT04821609
Supervised Resistance TRaining amONG Women at Risk of Breast Cancer Related Lymphedema
A study testing Resistance Training in people with Breast Cancer and Physical Activity, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
Breast cancer (BC) is the most common neoplasm in Chile, and its medical treatment leads to high survival. One-third of survivors will develop BC-related lymphedema. Lymphedema is a chronic condition characterized by increased volume in the ipsilateral arm to surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Physical Activity, Lymphedema of Upper Arm
- 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
- 106 participants
- Where
- 1 siteChile
- Study dates
- 1 Dec 2021to Jun 2023
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed with stage I-III breast cancer, histologically confirmed.
- Patients scheduled to receive adjuvant post-operative chemotherapy.
- Partial or total mastectomy with axillary node dissection.
- Partial or total mastectomy with sentinel node dissection with body mass index between 30.0 and 39.9 kg/m2.
- Approval of their treating physician to participate in sub-maximal physiological fitness testing and a low to moderate progressive resistance exercise program.
Who cannot join
- Inter-limb volume difference greater than 200 ml or 10%.
- Previous antineoplastic treatment (chemotherapy, radiotherapy, or endocrine therapy).
- Breast cancer stage IV
- Unable to participate in an exercise program related to other medical problems.
- Be identified as vigorous exercise behavior related to American College of Sports Medicine recommendations.
- Body mass index lower than 18.5 kg/m2 or greater than 40 kg/m2.
- Pregnancy.
- Fluency and understanding of the Spanish language.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Karol Ramírez
Puente Alto, CO
Karol Ramírez, kramirezp@uc.cl
About this study
Official title: "Effect of Supervised Resistance Training on Arm Volume and Quality of Life amONG Women at High Risk for Breast Cancer-related Lymphedema: a Study Protocol for a Randomized Controlled Trial (STRONG-B)"
Breast cancer (BC) is the most common neoplasm in Chile, and its medical treatment leads to high survival. One-third of survivors will develop BC-related lymphedema. Lymphedema is a chronic condition characterized by increased volume in the ipsilateral arm to surgery. A higher volume is associated with decreased physical functionality and quality of life. Recent studies suggest that resistance training could control arm volume through increased muscle mass development, improving physical functionality and quality of life for patients. To our knowledge, there is no study that has analyzed the effect of a resistance training program among women at risk of BC-related lymphedema on arm volume and quality of life. The purpose of this study is to determine the effect of resistance training on the arm volume and quality of life among women with adjuvant chemotherapy and high risk of BC-related lymphedema compared to a control group with regular physical therapy management, which does not include resistance training.
This is a randomized controlled study. It will be held at the Complejo Asistencial Dr. Sotero del Río, which receives all patients from the South East Metropolitan Health Service. Participants: 106 women receiving adjuvant chemotherapy for BC who have undergone axillary lymph node dissection or with obesity will be recruited. The difference in volume between the arms will be evaluated with optoelectric equipment. Quality of life with The European Organization for Research and Treatment in Cancer Quality of Life C-30 (EORTC QLQ-C30) and the European Organization for Research and Treatment of Breast Cancer-Specific Quality of Life Questionnaire BR23 (EORTC QLQ-BR23) questionnaires, both validated in Chile; the handgrip with a dynamometer; and physical functionality with the six-minute walk test. Volunteers will be randomly assigned to the resistance training group or control group. The resistance training group will consist of twice a week supervised sessions, for 12 weeks. The exercises will be for arms and legs, self-loading type, and with external weights. The control group will follow the usual physical therapy management, which does not include resistance training. Subsequently, volunteers will be evaluated at the third and sixth months after completion of the 12 weeks resistance training program.
- Conditions
- Breast Cancer, Physical Activity, Lymphedema of Upper Arm
- Being tested
- Resistance Training
- Keywords
- Resistance training, Quality of life
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingBehavioural
The resistance training will be for arms and legs, self-loading type, and external weights.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training group | Experimental | Twice a week sessions supervised and group, during 12 weeks Receives: Behavioral: Resistance Training |
| Control Group | No intervention | The control group will follow the usual physical therapy management, which does not include resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Arms lymphedema Volume on the Perometer System at 3, 6 and 9 months.
Perometer is considered the gold standard for determining lymphedema volume in research. Is a valid and reliable tool in volume measurement. It determines volume values expressed in milliliters and percentage. A value of 200 mL or 10% difference between one arm and the other is considered significant.
Measured: Baseline, 3, 6 and 9 months.
Change from Baseline in Health-related quality of life on questionnaire: The European Organization for Research and Treatment in Cancer (EORTC) Quality of Life C-30 (QLQ-C30) and breast cancer-specific module QLQ-BR23 at 3, 6, and 9 months.
The QLQ C-30 and specific module QLQ-BR23 are self-administered and validated questionnaires to assess health-related quality of life in patients with breast cancer. Both had been validated in Spanish language and on Chilean population. QLQ-C30 comprises 30 items to assess physical, role, emotional, cognitive, and social functioning. The QLQ-BR23 is a breast-specific module that comprises 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects. All scores were linearly transformed to a 0 to 100 scale. A high functional score represents a high or healthy level of functioning. A high QOL is defined by a high score for global health status or QOL. High symptom scores or items represent more severe symptoms or problems.
Measured: Baseline, 3, 6 and 9 months.
Secondary outcomes (2)
Change from Baseline in Hand grip strength on Hydraulic Hand Dynamometer at 3, 6 and 9 months.
Dynamometer assess the maximal voluntary grip strength (measured in kilograms). Each subject will perform six trials, three in each arm, with an alternating bilateral sequence. The results will be based on the best punctuation of the three trials, respectively. There are normative values in percentiles for healthy Chilean women.
Measured: Baseline, 3, 6, and 9 months.
Change from Baseline in Physical Fitness Six minute walk test at 3, 6 and 9 months.
Six minute walk test is a functional test of sub-maximum cardiorespiratory capacity. Valid and reliable in adults with cancer. Result are expressed in meters. A change of 20-30 meters is considered significant.
Measured: Baseline and 3, 6 and 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Dec 2021
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Granada, National Fund for Research and Development in Health, Chile, Hospital Dr Sotero del Rio
- Responsible party
- Sponsor
- Investigators
- Irene Cantarero, Ph.D, Study director, Universidad de GranadaKarol Ramírez, Ph.D (c), Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821609
- Sponsor's protocol ID
- SA20I0060
- Acronym
- STRONG-B
- Status last verified
- Dec 2021
- First submitted
- 11 Mar 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ramirez-Parada K, Sanchez C, Cantarero-Villanueva I, Reyes A, Pinto MP, Bravo ML, Montt-Blanchard D, Acevedo F, Walbaum B, Alfaro-Barra M, Barra-Navarro M, Munoz-Flores S, Pinto C, Muniz S, Contreras-Briceno F, Merino T, Merino G. Randomized Trial Assessing Prospective Surveillance and Exercise for Preventing Breast Cancer-Related Lymphedema in High-Risk Patients. Arch Phys Med Rehabil. 2025 Aug;106(8):1163-1172. doi: 10.1016/j.apmr.2025.03.002. Epub 2025 Mar 11.
PubMed 40081785Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
PubMed 39606939Ramirez-Parada K, Lopez-Garzon M, Sanchez-Rojel C, Petric-Guajardo M, Alfaro-Barra M, Fernandez-Verdejo R, Reyes-Ponce A, Merino-Pereira G, Cantarero-Villanueva I. Effect of Supervised Resistance Training on Arm Volume, Quality of Life and Physical Perfomance Among Women at High Risk for Breast Cancer-Related Lymphedema: A Study Protocol for a Randomized Controlled Trial (STRONG-B). Front Oncol. 2022 Mar 1;12:850564. doi: 10.3389/fonc.2022.850564. eCollection 2022.
PubMed 35299753
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effect of Supervised Resistance Training on Arm Volume and Quality of Life amONG Women at High Risk for Breast Cancer-related Lymphedema: a Study Protocol for a Randomized Controlled Trial (STRONG-B)"
- ClinicalTrials.gov ID
- NCT04821609
- Acronym / sponsor ID
- STRONG-B / SA20I0060
- Conditions
- Breast Cancer, Physical Activity, Lymphedema of Upper Arm
- Keywords
- Resistance training, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Universidad de Granada, National Fund for Research and Development in Health, Chile, Hospital Dr Sotero del Rio
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 29 Mar 2021 (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 (BC) is the most common neoplasm in Chile, and its medical treatment leads to high survival. One-third of survivors will develop BC-related lymphedema. Lymphedema is a chronic condition characterized by increased volume in the ipsilateral arm to surgery. A higher volume is associated with decreased physical functionality and quality of life. Recent studies suggest that resistance training could control arm volume through increased muscle mass development, improving physical functionality and quality of life for patients. To our knowledge, there is no study that has analyzed the effect of a resistance training program among women at risk of BC-related lymphedema on arm volume and quality of life. The purpose of this study is to determine the effect of resistance training on the arm volume and quality of life among women with adjuvant chemotherapy and high risk of BC-related lymphedema compared to a control group with regular physical therapy management, which does not include resistance training.
This is a randomized controlled study. It will be held at the Complejo Asistencial Dr. Sotero del Río, which receives all patients from the South East Metropolitan Health Service. Participants: 106 women receiving adjuvant chemotherapy for BC who have undergone axillary lymph node dissection or with obesity will be recruited. The difference in volume between the arms will be evaluated with optoelectric equipment. Quality of life with The European Organization for Research and Treatment in Cancer Quality of Life C-30 (EORTC QLQ-C30) and the European Organization for Research and Treatment of Breast Cancer-Specific Quality of Life Questionnaire BR23 (EORTC QLQ-BR23) questionnaires, both validated in Chile; the handgrip with a dynamometer; and physical functionality with the six-minute walk test. Volunteers will be randomly assigned to the resistance training group or control group. The resistance training group will consist of twice a week supervised sessions, for 12 weeks. The exercises will be for arms and legs, self-loading type, and with external weights. The control group will follow the usual physical therapy management, which does not include resistance training. Subsequently, volunteers will be evaluated at the third and sixth months after completion of the 12 weeks resistance training program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance training group | Experimental | Behavioral: Resistance TrainingTwice a week sessions supervised and group, during 12 weeks |
| Control Group | No intervention | –The control group will follow the usual physical therapy management, which does not include resistance training |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed with stage I-III breast cancer, histologically confirmed.
- Patients scheduled to receive adjuvant post-operative chemotherapy.
- Partial or total mastectomy with axillary node dissection.
- Partial or total mastectomy with sentinel node dissection with body mass index between 30.0 and 39.9 kg/m2.
- Approval of their treating physician to participate in sub-maximal physiological fitness testing and a low to moderate progressive resistance exercise program.
Key exclusion criteria (8 listed)
- Inter-limb volume difference greater than 200 ml or 10%.
- Previous antineoplastic treatment (chemotherapy, radiotherapy, or endocrine therapy).
- Breast cancer stage IV
- Unable to participate in an exercise program related to other medical problems.
- Be identified as vigorous exercise behavior related to American College of Sports Medicine recommendations.
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 TrainingThe resistance training will be for arms and legs, self-loading type, and external weights. | Behavioural | Resistance training group |
Primary outcome
Change from Baseline in Arms lymphedema Volume on the Perometer System at 3, 6 and 9 months.
Time frame: Baseline, 3, 6 and 9 months.
Perometer is considered the gold standard for determining lymphedema volume in research. Is a valid and reliable tool in volume measurement. It determines volume values expressed in milliliters and percentage. A value of 200 mL or 10% difference between one arm and the other is considered significant.
Change from Baseline in Health-related quality of life on questionnaire: The European Organization for Research and Treatment in Cancer (EORTC) Quality of Life C-30 (QLQ-C30) and breast cancer-specific module QLQ-BR23 at 3, 6, and 9 months.
Time frame: Baseline, 3, 6 and 9 months.
The QLQ C-30 and specific module QLQ-BR23 are self-administered and validated questionnaires to assess health-related quality of life in patients with breast cancer. Both had been validated in Spanish language and on Chilean population. QLQ-C30 comprises 30 items to assess physical, role, emotional, cognitive, and social functioning. The QLQ-BR23 is a breast-specific module that comprises 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects. All scores were linearly transformed to a 0 to 100 scale. A high functional score represents a high or healthy level of functioning. A high QOL is defined by a high score for global health status or QOL. High symptom scores or items represent more severe symptoms or problems.
2 secondary outcomes
Change from Baseline in Hand grip strength on Hydraulic Hand Dynamometer at 3, 6 and 9 months.
Time frame: Baseline, 3, 6, and 9 months.
Change from Baseline in Physical Fitness Six minute walk test at 3, 6 and 9 months.
Time frame: Baseline and 3, 6 and 9 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Derived from this study: PubMed 40081785Ramirez-Parada K, Sanchez C, Cantarero-Villanueva I, Reyes A, Pinto MP, Bravo ML, Montt-Blanchard D, Acevedo F, Walbaum B, Alfaro-Barra M, Barra-Navarro M, Munoz-Flores S, Pinto C, Muniz S, Contreras-Briceno F, Merino T, Merino G. Randomized Trial Assessing Prospective Surveillance and Exercise for Preventing Breast Cancer-Related Lymphedema in High-Risk Patients. Arch Phys Med Rehabil. 2025 Aug;106(8):1163-1172. doi: 10.1016/j.apmr.2025.03.002. Epub 2025 Mar 11.
- Derived from this study: PubMed 39606939Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
- Derived from this study: PubMed 35299753Ramirez-Parada K, Lopez-Garzon M, Sanchez-Rojel C, Petric-Guajardo M, Alfaro-Barra M, Fernandez-Verdejo R, Reyes-Ponce A, Merino-Pereira G, Cantarero-Villanueva I. Effect of Supervised Resistance Training on Arm Volume, Quality of Life and Physical Perfomance Among Women at High Risk for Breast Cancer-Related Lymphedema: A Study Protocol for a Randomized Controlled Trial (STRONG-B). Front Oncol. 2022 Mar 1;12:850564. doi: 10.3389/fonc.2022.850564. eCollection 2022.
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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. This study is not recruiting at the moment.
Irene Cantarero, Ph.D study director
Universidad de Granada
Karol Ramírez, Ph.D (c) principal investigator
Pontificia Universidad Catolica de Chile
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 and Physical Activity, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 5 inclusion and 8 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 13 Jan 2022. 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 Chile. 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?
Contact Karol Ramírez, Ph.D (c) (22 3541168, kramirezp@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Arms lymphedema Volume on the Perometer System at 3, 6 and 9 months. (time frame: Baseline, 3, 6 and 9 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04821609, which also lists 3 linked publications.
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 13 Jan 2022.