UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053991 |
|---|---|
| Receipt number | R000060974 |
| Scientific Title | A prospective observational study using a wearable device to assess physical activity in early-stage breast cancer patients starting neoadjuvant chemotherapy.(TRACK-BC) |
| Date of disclosure of the study information | 2024/03/28 |
| Last modified on | 2024/03/28 13:13:52 |
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Basic information
Public title
A prospective observational study using a wearable device to assess physical activity in early-stage breast cancer patients starting neoadjuvant chemotherapy.(TRACK-BC)
Acronym
TRACK-BC
Scientific Title
A prospective observational study using a wearable device to assess physical activity in early-stage breast cancer patients starting neoadjuvant chemotherapy.(TRACK-BC)
Scientific Title:Acronym
TRACK-BC
Region
| Japan |
Condition
Condition
Patients with early-stage breast cancer (Stage I-IIIA) scheduled to start neoadjuvant chemotherapy in an outpatient setting
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the amount of change in physical activity due to chemotherapy in early-stage breast cancer patients starting neoadjuvant chemotherapy, and to investigate the relationship between changes in physical activity and changes in health status.
Basic objectives2
Others
Basic objectives -Others
To investigate the feasibility of using a wearable device to objectively measure physical activity in early-stage breast cancer patients starting neoadjuvant chemotherapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in physical activity (TPA and MVPA) measured using a wearable device from the average value during the baseline period (7 days before the start of chemotherapy) to the 7-day average value from the start of the 2nd cycle of chemotherapy to 7 days after the start of chemotherapy.
The following two scores are set as the amount of physical activity:
-Total Physical Activity (TPA)
Metabolic Equivalent for Tasks (METs*) x Total Time (hours) Performed.
*The intensity of an activity is indicated by how many times more energy is expended than when the resting state is set to 1.
-Moderate to Vigorous Physical Activity (MVPA)
Time spent in physical activity of 3 METs or more.
Key secondary outcomes
1. Amount of changes from baseline in activity-related (TPA, MVPA, sedentary time, calories burned, distance traveled, vertical distance traveled, number of steps), sleep-related (sleep duration, sleep duration in each sleep stage [deep sleep, shallow sleep, REM sleep, wakefulness]), heart rate-related (heart rate, resting heart rate, heart rate zone time during activity [time heart rate increases to a specific value]), and other (respiratory rate, blood oxygen saturation, skin temperature) measured using a wearable device.
2. Amount of change from baseline in PRO-CTCAE* (Patient-Reported Outcome Common Terminology Criteria for Adverse Events) each item and HADS (Hospital Anxiety and Depression Scale) each score.
3. Amount of change from baseline in physical activity (TPA and MVPA) measured by wearable devices for each PRO-CTCAE* item and each HADS score.
4. Building a model with activity-related (TPA, MVPA, sedentary time, calories burned, distance traveled, vertical distance traveled, number of steps), sleep-related (sleep duration, sleep duration in each sleep stage [deep sleep, shallow sleep, REM sleep, wakefulness]), heart rate-related (heart rate, resting heart rate, heart rate zone time during activity), and other (respiratory rate, blood oxygen saturation, skin temperature)measured using a wearable device as an explanatory variable.
* 11 items of the PRO-CTCAE questionnaire including decreased appetite, nausea, vomiting, shortness of breath, swelling, heart palpitations, numbness , memory, joint pain, insomnia, fatigue are evaluated.
5. Average daily wear time of the wearable device and percentage of study subjects who wore the device for more than the specified time.
6. SyncWell input compliance rate for each study subject.
7. Percentage of treatment completed by each cohort and by each chemotherapy regimen.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who have freely and voluntarily given their consent to participate in research, either electronically or in writing.
2) Patients who are at least 18 years of age at the time consent is obtained.
3) Patients diagnosed with early-stage breast cancer (Stage I-IIIA).
4) Patients scheduled to start neoadjuvant chemotherapy within 28 days after 7 days of obtaining consent.
5) Patients newly starting neoadjuvant chemotherapy with one of the following three regimens in one of the following three cohorts after obtaining consent.
-Cohort1
(1)Pembrolizumab + paclitaxel every week + carboplatin every week
(2)Pembrolizumab + paclitaxel every week + carboplatin every 3 weeks
-Cohort2
(1)dose dense doxorubicin + cyclophosphamide
(2)dose dense epirubicin + cyclophosphamide
-Cohort3
(1)Doxorubicin + cyclophosphamide every 3 weeks
(2)Epirubicin + cyclophosphamide every 3 weeks
(3)Docetaxel + cyclophosphamide every 3 weeks +/- anti-HER2 therapy
(4)Docetaxel + anti-HER2 therapy every 3 weeks
6) Patients who have a smartphone that meets the following requirements, can operate the study's wearable device and electronic patient-reported outcomes system (SyncWell), and are deemed by the investigator to be able to continue wearing the wearable device and using SyncWell daily.
Requirements: iPhone with iOS 15 or higher installed or smartphone with Android 11 or higher installed.
7) Patients who wear the wearable device for at least 7 days after obtaining informed consent and before starting neoadjuvant chemotherapy, and who are able to obtain baseline data.
Key exclusion criteria
1) Patients who have received previous drug therapy for breast cancer.
2) Patients who may experience a significant decrease in physical activity measured by the wearable device, such as those who use a wheelchair.
3) Patients who are deemed by the investigators or others to be ineligible because of psychiatric disorders that may affect the evaluation to be conducted in this study.
4) Patients who are scheduled to be hospitalized during participation in the study.
5) Patients who are scheduled to travel abroad during participation in the study.
6) Pregnant patients or patients who plan to become pregnant during the study period.
7) Patients who are participating or will participate in a clinical trial involving an intervention.
8) Patients who are deemed inappropriate as research subjects by the investigators or others, regardless of the reason.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Kikawa |
Organization
Kansai Medical University Hospital
Division name
Breast Surgery
Zip code
573-1191
Address
573-1191,2-3-1 Shinmachi, Hirakata City, Osaka, Japan
TEL
072-804-0101
bj.u1ro@gmail.com
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Kikawa |
Organization
Kansai Medical University Hospital
Division name
Breast Surgery
Zip code
573-1191
Address
573-1191,2-3-1 Shinmachi, Hirakata City, Osaka, Japan
TEL
072-804-0101
Homepage URL
bj.u1ro@gmail.com
Sponsor or person
Institute
Kansai Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Hospital Research Ethics Review Committee
Address
2-3-1 Shinmachi, Hirakata City, Osaka, Japan
Tel
072-804-0101
rinriirb@hirakata.kmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
兵庫県立尼崎総合医療センター（兵庫県）、社会医療法人博愛会相良病院（鹿児島県）、医療法人渓仁会手稲渓仁会病院（北海道）、八尾市立病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 03 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060974
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