UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057809 |
|---|---|
| Receipt number | R000066077 |
| Scientific Title | Effect of seated vs supine posture during docetaxel infusion on left lower-limb extracellular water and clinical edema in patients with breast cancer: a single-center, parallel-group, open-label, exploratory randomized controlled trial |
| Date of disclosure of the study information | 2025/05/09 |
| Last modified on | 2026/05/09 19:58:52 |
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Basic information
Public title
A study of how seated or supine posture during docetaxel infusion affects lower-limb water content in patients with breast cancer
Acronym
DTX-POSTUREl
Scientific Title
Effect of seated vs supine posture during docetaxel infusion on left lower-limb extracellular water and clinical edema in patients with breast cancer: a single-center, parallel-group, open-label, exploratory randomized controlled trial
Scientific Title:Acronym
DTX-POSTURE
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily evaluate the effects of sitting versus lying down postures on lower limb fluid volume during docetaxel administration in breast cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition
Key secondary outcomes
Incidence of edema
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Seated group: After randomization, participants receive docetaxel infusion in a seated position in a reclining chair during all 4 cycles of docetaxel therapy. The backrest angle may be adjusted for patient comfort, but both lower limbs are kept dependent toward the floor during infusion. The docetaxel dose, infusion time, premedication, fluid administration, supportive care, and usual care are determined by the attending physician and institutional practice. Compression therapy, dietary guidance, diuretics, or other edema- or fluid-related management are not specified as study interventions.
Interventions/Control_2
Supine group: After randomization, participants receive docetaxel infusion in a supine position on a bed during all 4 cycles of docetaxel therapy. The trunk and lower limbs are kept approximately horizontal. Use of a pillow is allowed, but additional cushions for the purpose of lower-limb elevation are not used. The docetaxel dose, infusion time, premedication, fluid administration, supportive care, and usual care are determined by the attending physician and institutional practice. Compression therapy, dietary guidance, diuretics, or other edema- or fluid-related management are not specified as study interventions.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Patients who have received sufficient explanation and provided written informed consent voluntarily
-Patients who are 18 years or older at the time of consent
Key exclusion criteria
Patients will be excluded if they meet any of the following conditions:
-Presence of lower limb lymphedema
-Diagnosed with conditions that may cause edema:
Deep vein thrombosis of the lower limbs
Severe cardiac or pulmonary disease
Severe hepatic or renal dysfunction
Other metabolic disorders
-Implanted pacemaker
-Unable to maintain posture required for ultrasound examination
-Any other reason deemed inappropriate by the principal or co-investigators
Rationale: To exclude confounding causes of edema and ensure safety and data validity.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nagae |
| Middle name | |
| Last name | KAWASUSO |
Organization
Fujita Health University
Division name
Department of Gerontological Nursing, School of Nursing, Faculty of Health Sciences, Fujita Health University
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
TEL
0562-93-9084
nagae.kawasuso@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Nagae |
| Middle name | |
| Last name | KAWASUSO |
Organization
Fujita Health University
Division name
Faculty of Nursing, School of Health Sciences
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
TEL
0562-93-9084
Homepage URL
nagae.kawasuso@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Nagae KAWASUSO
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.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
愛知県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 09 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000066077
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
25
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
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Type: Interventional study (minimally invasive)
Design: Randomized controlled trial (pilot study)
Ethics Approval: Approved by the Ethics Review Committee of Fujita Health University
Data Collection: Body composition via InBody, ultrasound imaging, physical examination, and questionnaires
Data Anonymization: Use of subject codes with strict data protection (password-locked and physically secured)
Participant Considerations: Efforts made to minimize physical and psychological burden and avoid interfering with routine clinical care
Management information
Registered date
| 2025 | Year | 05 | Month | 09 | Day |
Last modified on
| 2026 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066077
