NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1071230057

Registered date:05/09/2023

A study on changes in nutritional status in patients with medication-related osteonecrosis of the jaw

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedMedication-related osteonecrosis of the jaw
Date of first enrollment16/10/2023
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)Patients who meet the registration requirements are aske d to take two nutritional supplements (whey peptide-cont aining liquid diet) a day for a total of 14 days, 7 days befor e surgery and 7 days after surgery. Evaluation of improvement in nutritional status and safety evaluation will be performed on the 8th day after surgery.

Outcome(s)

Primary OutcomeNutritional status 8 days after surgery (serum albumin, ser um total protein, prealbumin)
Secondary OutcomePresence or absence of postoperative complications, changes in nutritional status 1 to 3 months after surgery (weight change rate, BMI, CONUT value)

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteriaPatients aged 18 years or older at the time of informed consent Regardless of gender Performance Status From 0 to 2 Patients who have given written informed consent of their own free will after receiving sufficient explanation about participating in this study
Exclude criteriaPatients who have difficulty in taking nutritional supplements orally before surgery For example, patients with severe dementia or on parenteral nutrition Patients on dialysis Patients with diabetes (HbA1c of 6.5 or high) Obese patients (BMI of 25 or high) Patients with milk allergy or soy allergy Other patients who are judged by the attending physician to be inappropriate as research subjects

Related Information

Contact

Public contact
Name Masahito Hara
Address 1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501 Nagasaki Japan 852-8501
Telephone +81-95-819-7704
E-mail hara.m@nagasaki-u.ac.jp
Affiliation Nagasaki University Hospital
Scientific contact
Name Masahito Hara
Address 1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501 Nagasaki Japan 852-8501
Telephone +81-95-819-7704
E-mail hara.m@nagasaki-u.ac.jp
Affiliation Nagasaki University Hospital