UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049774 |
|---|---|
| Receipt number | R000056558 |
| Scientific Title | The effect of cancer cachexia on vascular endothelial glycocalyx and body composition |
| Date of disclosure of the study information | 2022/12/15 |
| Last modified on | 2023/06/14 12:38:16 |
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Basic information
Public title
The effect of cancer cachexia on vascular endothelial glycocalyx and body composition
Acronym
The effect of cancer cachexia on vascular endothelial glycocalyx and body composition
Scientific Title
The effect of cancer cachexia on vascular endothelial glycocalyx and body composition
Scientific Title:Acronym
The effect of cancer cachexia on vascular endothelial glycocalyx and body composition
Region
| Japan |
Condition
Condition
cancer cachexia
Classification by specialty
| Hematology and clinical oncology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine whether glycocalyx is disrupted by cancer cachexia and to elucidate how glycocalyx damage affects fluid retention and life expectancy
Basic objectives2
Others
Basic objectives -Others
In the terminal stage of cancer, fluid retention often occurs and causes distress. However, the mechanism of fluid retention is unknown. Recently, it has been shown that vascular endthelial glycocalyx is involved vascular permeability. Glycocalyx destruction is caused by systemic inflammation. Cancer cachexia is present in 80% of patients with advanced cancer. Systemic inflammation is a major contributor to cancer cachexia, but it is not known how it affects glycocalyx.
Glycocalyx is composed of proteoglycans and glycosaminoglycans. Some studies have been conducted using the constituent factors syndecan-1 and heparan sulfate as biomarkers.
In this study, we aim to elucidate the role of glycocalyx destruction by cancer cachexia by evaluating the plasma biomarker of glycocalyx, and by evaluating fluid retention using a body composition analyzer. And we will also discuss whether syndecan-1/heparan sulfate is a predictor of prognosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in plasma syndecan-1 and heparan sulfate concentrations over time between the high PPI and low PPI groups
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cancer patients aged 20 years or older who are admitted to the University of Yamanashi hospital between January 4, 2023 and December 31, 2024, and who request support from the palliative care team. (There are no restrictions on gender or upper age limit.)
Patients diagnosed with cancer cachexia
Diagnostic criteria is below.
(1) Weight loss >5% in the past 6 months
(2) BMI < 20, weight loss > 2% in the past 6 months
(3) Sarcopenia, weight loss > 2% in the past 6 months
((1), (2), or (3) are met)
Patients who can give written consent to participate in this study
Patients who can communicate in Japanese
Key exclusion criteria
1)Patients with serious cardiac or renal disease at the time of study enrollment
2)Patients with arteriovenous thrombosis
3)Patients with an implantable pacemaker
4)Patients with artificial limbs
5)Patients with a history of fatal arrhythmia
6)Patients who are judged by the physician to be ineligible
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yasutomo |
| Middle name | |
| Last name | Kumakura |
Organization
University of Yamanashi Hospital
Division name
Medical Team Center
Zip code
409-3898
Address
1110 Shimokawahigashi, Chuo City, Yamanashi Prefecture
TEL
055-273-1111
ykurakuma@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Yasutomo |
| Middle name | |
| Last name | Kumakura |
Organization
University of Yamanashi Hospital
Division name
Medical Team Center
Zip code
409-3898
Address
1110 Shimokawahigashi, Chuo City, Yamanashi Prefecture
TEL
055-273-1111
Homepage URL
ykurakuma@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, University of Yamanashi School of Medicine
Address
1110 Shimokawahigashi, Chuo City, Yamanashi Prefecture
Tel
055-273-9065
d0trial-med@yamanashi.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 15 | 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
| 2022 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study. Subjects will be all patients who were admitted to the University of Yamanashi Hospital between January 4, 2023 and December 31, 2024 and met the eligibility criteria. The study will be terminated when 80 cases have been collected. The evaluation contents are
1)Basic patient information: age, gender, height, weight, performance status, primary department, diagnosis, medical history, cancer treatment status, concomitant medications, comorbidities, date of admission
2)QOL evaluation: EOLTC QLQ-C15-PAL (questionnaire survey)
3)Delirium evaluation: DRS-R-98 (questionnaire survey)
4)Blood test data: general blood count and biochemical test items
5)Biomarker measurement: Syndecan-1/heparan-sulfate
6)Body fluid composition: total body water, extracellular water, lean body mass, skeletal muscle mass, body fat mass, and phase angle
7)Average daily infusion volume: obtained from electronic medical record information
8)Survival time
9)Adverse events
Management information
Registered date
| 2022 | Year | 12 | Month | 14 | Day |
Last modified on
| 2023 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056558
| Research Plan | |
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| Research case data | |
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