JPRN-jRCTs051220167
Recruiting
Phase 2
A randomized trial to evaluate the nutritional support with ISOCAL CLEAR and rehabilitation on prevention of skeletal muscle mass loss -a pilot study
Kiyoshi Maeda0 sites40 target enrollmentFebruary 13, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Esophageal Cancer
- Sponsor
- Kiyoshi Maeda
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\)Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma.
- •(2\)Stage II\-III
- •(3\)Aged 20 years and older.
- •(4\)ECOG Performance status 0 or 1\.
- •(5\)oral intake is possible
- •(6\)Major organ function is preserved.
- •(7\)Witten informed consent is obtained.
Exclusion Criteria
- •(1\)Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy.
- •(2\)Active infection requiring systemic therapy.
- •(3\)Fever over 38 degrees Celsius
- •(4\)Female during pregnancy, within 28 days of postparturition, or during lactation. Male who wants partner's pregnancy.
- •(5\)Psychological disorder difficult to participate in this clinical study.
- •(6\)Diabetes mellitus uncontrollable with continuous use of insuline or hypoglycemic agents.
- •(7\)Severe emphysema, interstitial pneumonia or pulmonary fibrosis based on chest CT.
- •(8\)Uncontrolled arterial hypertension.
- •(9\)Drug history of opioids, or stroids.
- •(10\)History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
Outcomes
Primary Outcomes
Not specified
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