Clinical study on oral squamous cell carcinoma patients with malnutrition

JRCT ID: jRCTs071230055

Registered date:29/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Oral squamous cell carcinoma
• Date of first enrollment: 02/11/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): To investigate the improvement of postoperative prognostic nutritional status (PNI) in patients with oral squamous cell carcinoma.

Outcome(s)

• Primary Outcome: Change in postoperative PNI
• Secondary Outcome: NLR, LMR, PLR, GPS, CONUT, Body weight, short-term nutritional index

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Adults over 18 years of age with a diagnosis of first oral squamous cell carcinoma for which surgery is indicated
2. Approximately anxiety or fatigue fatigue or anemia (HB <14g/dl, female 12g/dl)
3. Those who can take the test drug (including tube administration) within one week after surgery
4. Those who have obtained the consent of participation in this exam by writing

Exclude criteria

1. Those who cannot consume food and oral agents and digested and absorb
2. Those who are recognized for a decrease in obvious cognitive function
3. Patients who plan to provide postoperative chemotherapy and radiation therapy
4. Those who have been taking Kampo preparations within the past 2 weeks
5. Those who are using Anamorelin or are planning to use
6. Patient who was determined to be inappropriate due to the discretion of the researcher

Related Information

• Primary Sponsor: Suzuki Hajime
• Source(s) of Monetary Support: Kracie Pharma, Ltd