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Clinical study on oral squamous cell carcinoma patients with malnutrition

Clinical study on oral squamous cell carcinoma patients with malnutrition

20

The mean age was 67.5 years (range: 36-84 years), with 11 males (55.0%) and 9 females (45.0%). The mean BMI was 23.50 kg/m2 (range: 18.5-28.4 kg/m2). The primary site was most commonly the tongue (11 cases, 55.0%), followed by lower gingiva (3 cases, 15.0%), upper gingiva (2 cases, 10.0%), palate (2 cases, 10.0%), floor of mouth (1 case, 5.0%), and lip (1 case, 5.0%). Stage distribution was Stage I (7 cases, 35.0%), Stage II (7 cases, 35.0%), Stage III (3 cases, 15.0%), and Stage IVa (3 cases, 15.0%).

A total of 20 patients were enrolled as planned. Among the 20 enrolled patients, one patient never received the study drug, resulting in 19 patients included in both the Safety Analysis Set (SAS) and Efficacy Analysis Set (EAS). All 19 patients who received the study drug completed the trial with no discontinuations.

Among the 19 patients in the SAS, adverse events occurred in 13 patients (68.4%). The most frequent adverse events were diarrhea and decreased appetite (7 cases each, 36.8%). The most severe grade was grade 2, observed in eczema, maculopapular rash, urticaria, and pruritus (1 case each). No serious adverse events or unexpected serious adverse reactions suspected to be related to the study drug were reported.

The primary efficacy endpoint was the change in PNI (Prognostic Nutritional Index) from baseline to 8 weeks post-surgery, tested for superiority against the historical control threshold of -4.950 using a one-sample t-test. The mean change in PNI at 8 weeks post-surgery was -2.576 (95% CI: -4.743 to -0.410), with a p-value of 0.0335 against the historical threshold of -4.950, indicating statistical significance. This demonstrated that Ninjin-yoeito administration significantly suppressed post-operative PNI decline. For secondary endpoints, the mean PNI change at 4 weeks post-surgery was -5.782 (95% CI: -7.727 to -3.836) and the mean change rate was -11.284 (95% CI: -14.896 to -7.672). The mean PNI change rate at 8 weeks post-surgery was -5.016 (95% CI: -9.267 to -0.765). No significant results were obtained for these secondary endpoints when tested against their respective historical thresholds.

Administration of Kracie Ninjin-yoeito extract granules to oral squamous cell carcinoma patients with malnutrition significantly suppressed PNI decline at 8 weeks post-surgery, contributing to nutritional status improvement. Regarding safety, although expected adverse events occurred, no serious adverse events were reported, and tolerability was favorable. This study suggests the potential utility of Ninjin-yoeito in perioperative nutritional management of oral cancer patients.

July. 09, 2025

Yes

When sharing IPD data from this study, the following policies will be implemented: 1) Collaborative research framework Data sharing will be conducted as collaborative research with researchers from Kagoshima University, with final approval for data provision determined by the principal investigator. 2) Timing of data provision Data will be provided after publication of the primary analysis results. 3) Transparency assurance The fact of data provision will be disclosed on the institutional website to deter cases where data recipients do not publish results. 4) Ensuring reproducibility Recipients must provide analysis programs, logs, and outputs to the data center to confirm result reproducibility. Target data for sharing The dataset used for analyses based on the study protocol and statistical analysis plan, with anonymized individual clinical research participant data. Information that could identify individuals will be excluded. Sharing method Implementation will be through appropriate data sharing platforms or direct data provision. Data users must specify research objectives, analysis plans, and data management methods in advance and obtain approval from the principal investigator.

https://jrct.mhlw.go.jp/latest-detail/jRCTs071230055

Suzuki Hajime

Kagoshima University Hospital

8-35-1 Sakuragaoka, Kagoshima, Kagoshima

hajime@dent.kagoshima-u.ac.jp

Suzuki Hajime

Kagoshima University Hospital

8-35-1 Sakuragaoka, Kagoshima, Kagoshima

+81-99-275-6242

hajime@dent.kagoshima-u.ac.jp

Complete

Aug. 29, 2023

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

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

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

Both

Oral squamous cell carcinoma

To investigate the improvement of postoperative prognostic nutritional status (PNI) in patients with oral squamous cell carcinoma.

Change in postoperative PNI

NLR, LMR, PLR, GPS, CONUT, Body weight, short-term nutritional index

+81-99-275-6624

June. 29, 2023

none