臨床研究等提出・公開システム

Tolerability of oral nutrition supplementation for interstitial lung disease with a tendency toward weight loss

Tolerability of oral nutrition for interstitial lung disease with weight loss tendency

3

Three patients were enrolled, with a median patient age of 74 years and 72-75 years. Two patients had IPF, and one had idiopathic interstitial pneumonia; two were taking antifibrotic drugs, one each of pirfenidone and nintedanib.

The starting dose was ISOCAL100 100 mL (1 pack) orally once daily for 2 weeks. After 2 weeks, all three patients had no DLT and only two patients requested an increase in dose to 2 packs of ISOCAL 100. These two patients completed the study without any subsequent dose reduction. The duration of treatment in the study was four weeks.

No adverse events were observed in the study.

Primary endpoint No DLTs were observed in the study; after 2 weeks, all three patients had tolerated the drug without DLTs, but only two patients wanted to increase the dose to two packs ISOCAL 100. These two patients completed the study without dose reduction. Secondary endpoints All patients had weight loss approximately one month between screening and the start of the study. At 28 days, two of three patients in the study showed weight gain(+2.4 kg and +0.1 kg), while the remaining patient showed weight loss (-0.1 kg). No patients in the study discontinued or withdrew. In the food intake questionnaire, patients who increased their ONS to two bottles experienced an increase in food intake. The remaining one patient also had a flat food intake and did not show any decrease in food intake due to ONS intake. The Barthel index was used to assess activity. All patients had a perfect score before the start of the study, and none of them remained perfect or declined after 4 weeks. No adverse events were observed in the study. Tolerability was maintained in all periods of the study, and the prescribed doses could be taken without any leftovers.

The tolerability of ONS in ILD with weight loss was assessed. The study enrolled three patients with interstitial lung disease who had lost more than 1 kg of body weight in the previous 12 months. One pack of ISOCAL 100 was administered orally once daily for two weeks, tolerability was assessed after two weeks and the dose was increased to two if tolerated. A 3+3 dose design was planned with a dosing period of 4 weeks. No DLTs and no adverse events were observed at 28 days.

Aug. 31, 2024

No

Unscheduled

https://jrct.niph.go.jp/latest-detail/jRCTs031220119

Suzuki Takuji

Chiba University Hospital

1-8-1,Inohana,Chuo-ku,Chiba-City,Chiba,Japan

suzutaku@chiba-u.jp

Suzuki Takuji

Chiba University Hospital

1-8-1,Inohana,Chuo-ku,Chiba-City,Chiba,Japan

+81-43-222-7171

suzutaku@chiba-u.jp

Complete

June. 07, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) Patients diagnosed with interstitial lung disease
2) Patients aged 20 years and over at the time of obtaining consent
3) Patients with weight loss of at least 1 kg in the last 12 months
4) Patients who have been fully informed of the study and have obtained documentation of their own free will with full understanding of their participation in the study.

1) Patients with coexisting malignant disease
2) Patients with other diseases such as diabetes causing weight loss
3) Patients already taking oral nutritional supplements at least once a week
4) Patients receiving new medication within the past month for diarrhea as a side effect of antifibrotic drugs
5) Patients allergic to milk, soya and gelatine, which are ingredients of Isocal 100
6) Patients unable to give consent
7) Other patients deemed unsuitable for the safe conduct of the study by the principal investigator or the sub-investigator.

Both

interstitial lung disease

ISOCAL 100 100 ml (1 bottle) per day, taken orally for 28 days (in some cases up to 35 days). The dose may be increased to 200 ml (2 bottles) if tolerated at 14 days.

No incidence of dose-limiting toxicity over 28 days.

(a) Secondary efficacy endpoints
1) Change in body weight(kg) at 28 days.
2) Questionnaire assessment of food intake at 28 days.
3) Activity assessment using the Barthel index at 28 days.

(b) Secondary safety endpoints
1) All serious adverse events.
2) Adverse events for which a causal relationship to oral nutritional supplementation cannot be ruled out.

(c) Secondary endpoints of tolerability
Evaluation of ISOCAL 100 by patients.

+81-43-222-7171

May. 30, 2022

none