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Japanese

Jan. 25, 2022

Nov. 22, 2023

jRCT1030210581

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

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

Sato Hiroshi

Saitama Medical University International Medical Center

1397-1, Yamane, Hidaka-shi, Saitama

+81-49-284-4218

hs8401@5931.saitama-med.ac.jp

Mori Hiromi

Saitama Medical University International Medical Center

1397-1, Yamane, Hidaka-shi, Saitama

+81-49-284-4218

hm0249@5931.saitama-med.ac.jp

Suspended

Jan. 25, 2022

600

Interventional

randomized controlled trial

open(masking not used)

historical control

crossover assignment

treatment purpose

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

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

20age old over
No limit

Both

Digestive organ malignant tumor

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.

Gastrointestinal tumors from mouth to an anal canal or cancer

Nutrition care, medical care

D005770

D009747

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

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),

Toshiaki Saeki
Saitama Medical School International Medical Center Clinical Research Clinical Trial Review Committee
1397-1, Yamane, Hidaka-ctiy, Saitama

+81-42-984-4523

chikens@saitama-med.ac.jp
Approval

No

none

History of Changes

No Publication date
3 Nov. 22, 2023 (this page) Changes
2 July. 01, 2023 Detail Changes
1 Jan. 25, 2022 Detail