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

JRCT ID: jRCT1071230057

Registered date:05/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Medication-related osteonecrosis of the jaw
• Date of first enrollment: 16/10/2023
• Target sample size: 20
• 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)
• 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
• 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