A randomized study to evaluate the effecct of BCAA for preventing skeltal muscle mass

JRCT ID: jRCTs051220167

Registered date:13/02/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Esophageal Cancer
• Date of first enrollment: 24/02/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Randomization of oral intake of BCAA products during NAC

Outcome(s)

• Primary Outcome: Change of total skeltal muscle mass index during NAC

Secondary Outcome

1) Change of Weight, total skeltal muscle mass, appendicular muscle mass, and fat free mass index
2) Continuous rate of BCAA intake
3) Evaluation of appetite
4) Calory intake
5) Adverse events during NAC
6) Postoperative complications
7) Hopital stay after operation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.
(11) Allergy for milk (or protein from milk)
(12) Other reason why principal investigator considered ineligible

Related Information

• Primary Sponsor: Kiyoshi Maeda
• Source(s) of Monetary Support: Nestle Japan