Evaluation of the effect of nutritional therapy intervention in outpatients undergoing chemotherapy

JRCT ID: jRCT1030210581

Registered date:25/01/2022

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Digestive organ malignant tumor
• Date of first enrollment: 25/01/2022
• Target sample size: 600
• Study type: Interventional

Intervention(s)

For outpatient chemotherapy patients, we provide a nutrition education and a nutrition care (1-2 times/month).
Correlations, and the like with the change of the nutrition index (caloric intake,
nutrient sufficiency rate, diet balance, and the like), a blood biochemistry test value
(Alb, prealbumin, T-cho, TG, ChE, and the like) and the anthropometry (weight,
somatic fat volume, skeletal muscle mass, and the like) evaluate) and test the effect of the aggressive nutrition care by the comparison with the non-interposer. Also, by an
evaluation whether improvement (presence or absence of reduction of stress and the
anxiety in the dietary management, presence or absence, and the like of
consciousness change for the eating habits management) of the meal quality of life
was obtained by a nutrition
education, we determine an effect of the intervention.

Outcome(s)

• Primary Outcome: Nutritional status evaluation (biochemical examination of blood, frail evaluation, G8 evaluation or CAG evaluation, PG-SGA, anthropometry (weight, skinfold thickness) such as muscle mass, and the like, nutritional requirements, quantity of intake nutrient (sufficiency rate) to include, will, opinion to a nutrition care

Secondary Outcome

Clinical history, treatment strategy (we include the intention, and the like for the
treatment), living condition, background (family constitution, living environment, the
money situation, taste, activity, and so on),

Key inclusion & exclusion criteria

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

Include criteria

1.Outpatient chemotherapy patients (regimen subjects becoming a continuous administration or the administration week for two weeks)
2.Patients as described in 1 corresponding to the undernutrition risk extraction criteria that we set at this hospital

Exclude criteria

1.Patients (including the change to chemotherapy in the internal use) who came to have difficulty with outpatient chemotherapy continuation
2.Patients with social, religious, or psychological problems that make interventions other than the primary treatment difficult
3.The patients with the defect for data

Related Information

• Primary Sponsor: Sato Hiroshi