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Efficacy of herbal medicine TJ-14 for acute radiation-induced enteritis: a multi-institutional prospective Phase II trial
- Source :
- Journal of Radiation Research
- Publication Year :
- 2019
- Publisher :
- Oxford University Press, 2019.
-
Abstract
- The purpose of this multi-institutional Phase II trial study was to prospectively investigate the efficacy of the herbal medicine TJ-14 for acute radiation-induced enteritis (ARE). TJ-14 was administered orally as a first-line treatment for ARE. The primary end point was efficacy at 1 week. The secondary end points were: (i) the efficacy of TJ-14 at 2 and 3 weeks after its administration, (ii) the quality of life score (FACT-G) at 1, 2 and 3 weeks after its administration, and (iii) adverse events. If the efficacy of TJ-14 was observed in eight patients or fewer, its efficacy was rejected. Results: Forty patients receiving pelvic radiotherapy were enrolled. Of these, 22 developed ARE and received TJ-14. Among these, 19 had cervical cancer and 9 received chemoradiotherapy. TJ-14 efficacy was shown in 19 out of the 22 patients (86%). Stool frequency per day at 1 week significantly decreased (mean ± SD: 4.9 ± 2.1 vs 3.7 ± 1.9, P = 0.02). This effect continued at 2 (2.2 ± 1.4, P = 0.004) and 3 weeks (2.1 ± 0.9, P = 0.05). Thirteen out of the 22 patients (59%) continued TJ-14 until the end of radiotherapy. FACT-G score deterioration was not observed after the administration of TJ-14. Grade 1 hypokalemia was observed in 4 patients, and Grade 1 constipation in 3. We concluded that TJ-14 is sufficiently promising to be examined in a Phase III trial. A randomized controlled trial is currently being planned.
- Subjects :
- Adult
Male
medicine.medical_specialty
Constipation
acute radiation-induced enteritis
cervical cancer
Health, Toxicology and Mutagenesis
Enteritis
law.invention
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
law
Internal medicine
Clinical endpoint
Regular Paper
Medicine
Humans
Radiology, Nuclear Medicine and imaging
Adverse effect
Radiation Injuries
030304 developmental biology
Aged
Cervical cancer
Aged, 80 and over
0303 health sciences
Radiation
business.industry
Middle Aged
medicine.disease
Hypokalemia
Treatment Outcome
030220 oncology & carcinogenesis
TJ-14 (hangeshashinto
pelvic radiotherapy
herbal medicine
Acute Disease
Female
medicine.symptom
business
Chemoradiotherapy
Ban Xia Xie Xin Tang)
Drugs, Chinese Herbal
Subjects
Details
- Language :
- English
- ISSN :
- 13499157 and 04493060
- Volume :
- 61
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Journal of Radiation Research
- Accession number :
- edsair.doi.dedup.....8ec44ad4378bef26309ae32d69613982