A Study for Assessing the Efficacy and Safety of BH4 in Radiation Enteritis

Summary

This present study envisaged a single-center, prospective, open-label, placebo and randomized controlled phase II clinical study to assess the efficacy and Safety of Tetrahydrobiopterin in Treating Radiation Enteritis in Gynecological Cancer Patients.

Timeline

Start

2022-03-01

Primary completion

2023-10-01

Completion

2024-03-01

Publications

• Results Feng Y, Feng Y, Gu L, Liu P, Cao J, Zhang S. The Critical Role of Tetrahydrobiopterin (BH4) Metabolism in Modulating Radiosensitivity: BH4/NOS Axis as an Angel or a Devil. Front Oncol. 2021 Aug 27;11:720632. doi: 10.3389/fonc.2021.720632. eCollection 2021.
• Results Thabet NM, Rashed ER, Abdel-Rafei MK, Moustafa EM. Modulation of the Nitric Oxide/BH4 Pathway Protects Against Irradiation-Induced Neuronal Damage. Neurochem Res. 2021 Jul;46(7):1641-1658. doi: 10.1007/s11064-021-03306-0. Epub 2021 Mar 23.
• Results Yan T, Guo S, Zhang T, Zhang Z, Liu A, Zhang S, Xu Y, Qi Y, Zhao W, Wang Q, Shi L, Liu L. Ligustilide Prevents Radiation Enteritis by Targeting Gch1/BH4/eNOS to Improve Intestinal Ischemia. Front Pharmacol. 2021 Apr 22;12:629125. doi: 10.3389/fphar.2021.629125. eCollection 2021.
• Results Xue J, Yu C, Sheng W, Zhu W, Luo J, Zhang Q, Yang H, Cao H, Wang W, Zhou J, Wu J, Cao P, Chen M, Ding WQ, Cao J, Zhang S. The Nrf2/GCH1/BH4 Axis Ameliorates Radiation-Induced Skin Injury by Modulating the ROS Cascade. J Invest Dermatol. 2017 Oct;137(10):2059-2068. doi: 10.1016/j.jid.2017.05.019. Epub 2017 Jun 6.

Drugs

Indications