Breast NeoplasmsNCT07472803
Longitudinal Body Composition Assessment in Breast Cancer Patients
An observational study of Breast Neoplasms and Body Composition, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial summary
This observational cohort study aims to track longitudinal changes in body composition, including skeletal muscle mass and fat distribution, in patients diagnosed with breast cancer. Following primary surgery and adjuvant therapy, participants will be monitored over a 2-year period. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Body Composition, Sarcopenia
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 May 2025to 31 Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients with histologically confirmed primary breast cancer (Stage I-III) recruited from the Department of Breast Surgery/Oncology at the Taipei Buddhist Tzu Chi Hospital. The population includes individuals who have undergone surgical resection and are eligible for, currently receiving, or have recently completed adjuvant therapy (chemotherapy and/or radiotherapy). Patients are tracked through their post-surgical recovery and adjuvant treatment pathways
Who may be able to join
- >18 years of age
- Diagnosed with stage I-III non-metastatic breast cancer within 12 months of diagnosis
- Scheduled for surgery, chemotherapy, with or without radiotherapy or targeted therapy.
Who cannot join
- Women diagnosed with metastatic (stage IV) breast cancer
- Women planning to move away from the area or be away for more than 6 months during the study period
- Women planning to become pregnant during the study period
- Implantable devices (e.g., pacemaker, nerve stimulator) or surgical implants (e.g., total hip or knee replacements)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
New Taipei City, Xindian Dist, 231
Taipei Tzu Chi Hospital, +886266289779 ext. 5706, xdirb@tzuchi.com.tw
About this study
Official title: Long-term Evaluation of the Body Composition and the Impact of Resistance and Relaxation Exercise on Muscle Mass and Quality of Life in Patients With Breast Cancer
This observational cohort study aims to track longitudinal changes in body composition, including skeletal muscle mass and fat distribution, in patients diagnosed with breast cancer. Following primary surgery and adjuvant therapy, participants will be monitored over a 2-year period.
The primary objective is to evaluate the natural progression of skeletal muscle mass index (SMI) and metabolic changes in this population. By conducting serial measurements, this study seeks to characterize the longitudinal trends in muscle loss and body composition shifts post-treatment, providing data to better understand the physiological impact of the cancer recovery process.
- Conditions
- Breast Neoplasms, Body Composition, Sarcopenia, Fat Redistribution, Lymphedema
- Keywords
- Breast Cancer Survivors, Post-Treatment Recovery, Body Composition, Longitudinal Cohort Study, Skeletal Muscle Mass Index, Metabolic Monitoring, sarcopenia
- Medical subject headings
- Breast Neoplasms, Sarcopenia, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Post-Surgical Cohort | Patients with histologically confirmed Stage I-III non-metastatic breast cancer who have undergone primary surgery and are scheduled to undergo or have completed adjuvant therapy (chemotherapy and/or radiotherapy). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Skeletal Muscle Mass Index (SMI)
Skeletal Muscle Mass Index (SMI) is the primary metric for assessing muscle mass. It is a composite value calculated by dividing total skeletal muscle mass (kg), as measured by multifrequency bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare), by the square of the participant's height (m2). Weight and height are measured at each time point to calculate this single aggregated value (kg/m2). Higher scores indicate greater muscle mass relative to height (better outcome).Unit of Measure: kg/m2
Measured: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Secondary outcomes (10)
Functional Battery: Change from Baseline in Handgrip Strength
Handgrip strength of the dominant hand is measured using a hydraulic dynamometer (LiTE - 200 lb Capacity, USA). Participants perform three trials with a 1-minute rest between attempts; the highest (peak) value of the three trials is recorded. Higher scores indicate greater upper extremity muscle strength (better outcome). Unit of Measure: Kilograms (kg)
Measured: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Functional Battery: Change from Baseline in 4-Meter Gait Speed
The 4-meter gait speed (m/s) is measured using a standardized timed walk test. Participants are instructed to walk at their usual pace for 4 meters from a standing start. The time is recorded in seconds and converted to meters per second (m/s). Higher scores indicate faster walking speed (better outcome). Unit of Measure: Meters per second (m/s)
Measured: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Functional Battery: Change from Baseline in Timed Up & Go (TUG) Test
Functional mobility and balance are measured using the Timed Up \& Go (TUG) test. The time it takes for a participant to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down is recorded. Higher scores (longer time taken) indicate poorer functional mobility and balance (worse outcome). Unit of Measure: Seconds
Measured: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Functional Battery: Change from Baseline in 30-Second Chair Stand Test
Lower extremity functional strength is measured as the total number of stands completed in 30 seconds. Participants begin seated and are instructed to stand up and sit down as many times as possible within the 30-second window while keeping their arms crossed over their chest. Higher scores (more stands completed) indicate better lower extremity functional strength and endurance (better outcome). Unit of Measure: Number of stands
Measured: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Body Composition: Change from Baseline in Body Fat Mass
Body fat mass (kg) measured using bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). Higher scores indicate greater absolute body fat (worse outcome).
Measured: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Body Composition: Change from Baseline in Arm-to-Leg Lean Mass Ratio
The ratio of total arm lean soft tissue (kg) to total leg lean soft tissue (kg) derived from segmental bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). This ratio is calculated by dividing the sum of lean mass in both arms by the sum of lean mass in both legs. Higher scores indicate a greater proportion of upper limb lean mass relative to lower limb lean mass. Unit of Measure: Ratio
Measured: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Body Composition: Change from Baseline in Limb-to-Trunk Lean Mass Ratio
The ratio of total limb lean soft tissue (kg) to trunk lean soft tissue (kg) derived from segmental bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). This ratio is calculated by dividing the sum of lean soft tissue from all four limbs by the lean soft tissue of the trunk. Higher scores indicate a greater proportion of appendicular muscle mass relative to the trunk (better outcome). Unit of Measure: Ratio.
Measured: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Change from Baseline in Overall Edema Index
The Overall Edema Index is calculated as the ratio of Extracellular Water (ECW) to Total Body Water (TBW), as measured by multifrequency bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). This index evaluates systemic fluid distribution and edema progression. Higher scores indicate a higher level of extracellular fluid relative to total body water (worse outcome).
Measured: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Change from Baseline in Extracellular Water (ECW)
Extracellular Water (ECW) measured in liters via multifrequency bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). Unit of Measure: Liters.
Measured: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Change from Baseline in Intracellular Water (ICW)
Intracellular Water (ICW) measured in liters via multifrequency bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). Unit of Measure: Liters.
Measured: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start19 May 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472803
- Sponsor's protocol ID
- 13-IRB110-OBS
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in this article will be available to researchers who provide a methodologically sound proposal. Proposals may be submitted beginning 9 months and ending 36 months following article publication to the corresponding author. Data will be shared after approval of the proposal and the signing of a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Evaluation of the Body Composition and the Impact of Resistance and Relaxation Exercise on Muscle Mass and Quality of Life in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT07472803
- Acronym / sponsor ID
- 13-IRB110-OBS
- Conditions
- Breast Neoplasms, Body Composition, Sarcopenia, Fat Redistribution, Lymphedema
- Keywords
- Breast Cancer Survivors, Post-Treatment Recovery, Body Composition, Longitudinal Cohort Study, Skeletal Muscle Mass Index, Metabolic Monitoring, sarcopenia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Mar 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 observational cohort study aims to track longitudinal changes in body composition, including skeletal muscle mass and fat distribution, in patients diagnosed with breast cancer. Following primary surgery and adjuvant therapy, participants will be monitored over a 2-year period.
The primary objective is to evaluate the natural progression of skeletal muscle mass index (SMI) and metabolic changes in this population. By conducting serial measurements, this study seeks to characterize the longitudinal trends in muscle loss and body composition shifts post-treatment, providing data to better understand the physiological impact of the cancer recovery process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Post-Surgical Cohort | – | –Patients with histologically confirmed Stage I-III non-metastatic breast cancer who have undergone primary surgery and are scheduled to undergo or have completed adjuvant therapy (chemotherapy and/or radiotherapy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients with histologically confirmed primary breast cancer (Stage I-III) recruited from the Department of Breast Surgery/Oncology at the Taipei Buddhist Tzu Chi Hospital. The population includes individuals who have undergone surgical resection and are eligible for, currently receiving, or have recently completed adjuvant therapy (chemotherapy and/or radiotherapy). Patients are tracked through their post-surgical recovery and adjuvant treatment pathways
Key inclusion criteria (3 listed)
- >18 years of age
- Diagnosed with stage I-III non-metastatic breast cancer within 12 months of diagnosis
- Scheduled for surgery, chemotherapy, with or without radiotherapy or targeted therapy.
Key exclusion criteria (4 listed)
- Women diagnosed with metastatic (stage IV) breast cancer
- Women planning to move away from the area or be away for more than 6 months during the study period
- Women planning to become pregnant during the study period
- Implantable devices (e.g., pacemaker, nerve stimulator) or surgical implants (e.g., total hip or knee replacements)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Skeletal Muscle Mass Index (SMI)
Time frame: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Skeletal Muscle Mass Index (SMI) is the primary metric for assessing muscle mass. It is a composite value calculated by dividing total skeletal muscle mass (kg), as measured by multifrequency bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare), by the square of the participant's height (m2). Weight and height are measured at each time point to calculate this single aggregated value (kg/m2). Higher scores indicate greater muscle mass relative to height (better outcome).Unit of Measure: kg/m2
10 secondary outcomes
Functional Battery: Change from Baseline in Handgrip Strength
Time frame: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Functional Battery: Change from Baseline in 4-Meter Gait Speed
Time frame: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Functional Battery: Change from Baseline in Timed Up & Go (TUG) Test
Time frame: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Functional Battery: Change from Baseline in 30-Second Chair Stand Test
Time frame: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Body Composition: Change from Baseline in Body Fat Mass
Time frame: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Body Composition: Change from Baseline in Arm-to-Leg Lean Mass Ratio
Time frame: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Body Composition: Change from Baseline in Limb-to-Trunk Lean Mass Ratio
Time frame: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Change from Baseline in Overall Edema Index
Time frame: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Change from Baseline in Extracellular Water (ECW)
Time frame: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.
Change from Baseline in Intracellular Water (ICW)
Time frame: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following 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 16 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in this article will be available to researchers who provide a methodologically sound proposal. Proposals may be submitted beginning 9 months and ending 36 months following article publication to the corresponding author. Data will be shared after approval of the proposal and the signing of a data access agreement.
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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?
An observational study of Breast Neoplasms and Body Composition, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 16 Mar 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 Taiwan. 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 Valeria Chiu, Attending Physician (+886266289779 ext. 67702, haydenbell28@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skeletal Muscle Mass Index (SMI) (time frame: Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following 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 16 Mar 2026.