Unique ID issued by UMIN | UMIN000035002 |
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Receipt number | R000039808 |
Scientific Title | A retrospective cohort study to investigate the incidence of cachexia in colorectal cancer patients |
Date of disclosure of the study information | 2018/11/27 |
Last modified on | 2020/11/09 14:41:10 |
A retrospective cohort study to investigate the incidence of cachexia in colorectal cancer patients
A retrospective cohort study to investigate the incidence of cachexia in colorectal cancer patients
A retrospective cohort study to investigate the incidence of cachexia in colorectal cancer patients
A retrospective cohort study to investigate the incidence of cachexia in colorectal cancer patients
Japan |
Colorectal Cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate the frequency of onset and the time to onset of cancer cachexia by a retrospective cohort study, in patients who were diagnosed with unresectable advanced colorectal cancer for the first time and underwent systemic chemotherapy
Others
Retrospective observation study
Others
Others
Not applicable
The frequency of onset and the time to onset of cancer cachexia in patients who were diagnosed with unresectable advanced colorectal cancer for the first time and underwent systemic chemotherapy
1) Relationship between onset of cancer cachexia and changes in laboratory parameter
2) Relationship between cancer cachexia and overall survival
3) Relationship between cancer cachexia and the continuation rate of anticancer chemotherapy
4) Relationship between cancer cachexia and the introduction rate of secondary therapy
5) Relationship between onset of cancer cachexia and introduction rate of tertiary therapy
6) Relationship between cancer cachexia and severity and incidence of anorexia and fatigue
7) Correlation between the changes in body weight of >= 5% (or if BMI < 20, changes in body weight of >2%) and changes in each laboratory parameter during the first systemic chemotherapy period at 12-week intervals evaluated from the beginning day of the first systemic chemotherapy
Observational
Not applicable |
Not applicable |
Male and Female
Patients who satisfy all the following items are included
1) Patients diagnosed with progressive colorectal cancer that cannot be resected radically
2) Patients who were measured body weight periodically at the time of visit and during the subsequent medical consultation period
3) Received cancer chemotherapy during the study period
Patients who meet at least one of the following exclusion criteria are not included.
1) Patients who underwent surgical operation of the gastrointestinal tract within the last 6 months, excluding colostomy
and stent placement in the gastrointestinal tract
2) Patients with weight loss distinctly caused by a gastrointestinal transit disorder
3) Patients with simultaneously active, double cancer (Stage I intraepithelial carcinoma, intramucosal carcinoma, superficial bladder carcinoma, or other cancers without recurrence for 5 years or more can be registered)
4) Patients with missing of weight data over 12 weeks at the time of visit and during the subsequent medical consultation period
5) Patients who underwent puncture for ascitic fluid at the beginning of initial systemic chemotherapy
150
1st name | Eiji |
Middle name | |
Last name | Kasamatsu |
ONO PHARMACEUTICAL CO., LTD.
Medical Planning I
541-8564
8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka-shi 541-8564, Japan
662632992
e.kasamatsu@ono.co.jp
1st name | Satoshi |
Middle name | |
Last name | Hamauchi |
Shizuoka Cancer Center
Division of Gastrointestinal Oncology
411-8777
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture 411-8777 Japan
055-989-5222
s.hamauchi@scchr.jp
ONO PHARMACEUTICAL CO., LTD.
ONO PHARMACEUTICAL CO., LTD.
Profit organization
Exploratory Research Ethics Review Committee, Shizuoka Cancer Center
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture Japan
055-989-5222
tansaku_office@scchr.jp
NO
静岡県立静岡がんセンター(静岡県)
久留米大学病院がん集学治療センター(福岡県)
2018 | Year | 11 | Month | 27 | Day |
https://link.springer.com/article/10.1007/s12325-020-01516-6
Published
https://link.springer.com/article/10.1007/s12325-020-01516-6
150
Cumulative incidence of cancer cachexia was 50.7% at 24 weeks, and reached 91.3% over the whole study period. OS was significantly different between patients with and without cancer cachexia within 24 weeks after starting first-line treatment, although the onset of cancer cachexia within 24 weeks could not be considered as an independent prognostic factor for OS. Severe appetite loss and fatigue tended to occur more frequently in patients with cancer cachexia within 24 weeks.
2020 | Year | 11 | Month | 09 | Day |
2020 | Year | 10 | Month | 16 | Day |
A total of 150 patients (90 men and 60 women) were registered in this study Median age and BMI were 65 years (range 29-85) and 21.7 kg/m2 (14.8-32.5), respectively. The proportions of patients with ECOG PS0, PS1, and PS2 were 50.0%, 43.4%, and 6.0%, respectively. Primary tumor sites were rectum (60.0%) and colon (40.0%), and most patients had stage IV cancer (99.3%).
Medical records databases were searched to retrieve the records of patients who were diagnosed with advanced colorectal cancer with local progression or distant metastasis and who underwent first-line systemic chemotherapy for advanced colorectal cancer between February 1, 2010 and August 31, 2016 at Shizuoka Cancer Center Hospital and Kurume University Hospital.
Not applicable
Cumulative incidence of cancer cachexia was 50.7% at 24 weeks, and reached 91.3% over the whole study period. OS was significantly different between patients with and without cancer cachexia within 24 weeks after starting first-line treatment, although the onset of cancer cachexia within 24 weeks could not be considered as an independent prognostic factor for OS. Severe appetite loss and fatigue tended to occur more frequently in patients with cancer cachexia within 24 weeks.
Completed
2018 | Year | 11 | Month | 15 | Day |
2018 | Year | 11 | Month | 20 | Day |
2018 | Year | 11 | Month | 27 | Day |
2018 | Year | 11 | Month | 27 | Day |
This retrospective observational study is carried out on clinical data collected using the electronic data collection system (EDC) from the medical record of subjects. Patients who were initially diagnosed with progressive colorectal cancer that cannot be resected radically prior to August 31, 2016 and who underwent systemic chemotherapy at the sites are included in the study. Patient enrolment is based on a definitive diagnosis in the medical record. The medical records are collected for at least 1 year (maximum 3 years) from the date of the initial systemic chemotherapy.
<Contents collected>
1) Baseline characteristics (At the time of initial systemic chemotherapy)
Age, birth year/month, sex, height, body weight, complications (COPD, diabetes, hypertension, dyslipidemia, hypothyroidism etc.), ECOG PS, primary lesion (Rectum, colon), UICC staging, metastatic lesion (Lung, liver, bone, brain, distant lymph node, peritoneal metastasis etc.), laboratory parameter (Na, K, AST, ALT, AL-P, t-Bil, Neu, WBC, Plt, Cre, Alb, TLC, CRP, Hb), tumor marker (CA19-9, CEA), IVH, stoma (Ileum, colon), fatigue and anorexia
2) Clinical information collected every 4-week from the initial systemic chemotherapy
Body weight, ECOG PS, laboratory parameter, tumor marker, anorexia and fatigue, surgery related to the primary disease, severe ascites, IVH, stoma
3) Clinical information collected from all the consultation period
- Initial systemic chemotherapy [Regimen, initial/final date, reason for discontinuation, confirmation date of exacerbation, antitumor effect (RECIST ver1.1) ]
- Secondary/tertiary chemotherapy and if not done, the reason (Regimen, initial/final date)
- Final outcome (Survival, death, lost to follow-up)
2018 | Year | 11 | Month | 26 | Day |
2020 | Year | 11 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039808
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