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 | Suspended |
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Health condition(s) or Problem(s) studied | Medication-related osteonecrosis of the jaw |
Date of first enrollment | 16/10/2023 |
Target sample size | 20 |
Countries of recruitment | |
Study type | Interventional |
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 Outcome | Nutritional status 8 days after surgery (serum albumin, ser um total protein, prealbumin) |
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Secondary Outcome | Presence 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 |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | Patients 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 criteria | Patients 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
Primary Sponsor | Hara Masahito |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Kinuko Ogata |
Address | 1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501 Nagasaki Japan 852-8501 |
Telephone | +81-95-819-7704 |
ogata_kinuko@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 |
hara.m@nagasaki-u.ac.jp | |
Affiliation | Nagasaki University Hospital |