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Beclomethasone

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Participants inhaled beclomethasone propionate aerosol daily during chest radical radiotherapy (total dose 60GY).

Participants were not given daily inhalation of beclomethasone propionate when undergoing radical chest radiotherapy (total dose 60GY).

Beclomethasone propionate inhaled twice daily during radiotherapy

Beclomethasone propionate

caicun zhou, phD MD

jie zhang, MD

Radical radiotherapy is the main treatment of locally advanced lung cancer, and radiation pneumonia is the main toxic effects of radiotherapy. Among them, the fatality rate of severe radiation pneumonia can reach 50%, which is very harmful to tumor patients. At present, the treatment mode of radiation pneumonia is very few, and the therapeutic effect is poor. The prevention of radiation pneumonitis may be the best way to reduce the number of patients with Post-radiotherapy pneumonia. Previous small clinical studies have shown that the incidence of radiation pneumonia in inhaled beclomethasone group (2 /28) was significantly lower than that in oral prednisone group (8 /29) during radiotherapy. The purpose of this study was to compare the efficacy and safety of radiotherapy between the therapeutic group (inhaled beclomethasone during radiotherapy) and the control radiotherapy group (patients received radiotherapy only), especially the incidence of radiation-induced pneumonia within half a year.

To compare the incidence of radiation pneumonia, effect and side effects of radiotherapy in lung between beclomethasone inhalation therapeutic group and control radiotherapy group in patients with locally advanced non-small cell lung cancer (NSCLC) during radiotherapy.

Prevention of Locally Advanced NSCLC Radiotherapy Pneumonia by Inhaling Beclomethasone Propionate

A Randomized, Open Phase II Study of the Incidence and Safety of Radiation Pneumonia in Patients With Locally Advanced NSCLC Treated With Beclomethasone Propionate Inhaled During Radical Radiotherapy Compared With Conventional Radiotherapy

evaluated every 6 weeks since the thoracic irradiation began according to the EORTC Quality-of-Life Questionnarire-Lung Cancer 13 Module(EORTC OLO-LC13)

To evaluate the incidence of radiation pneumonia in 36weeks since thoracic irradiation between two groups of patients

To evaluate Objective response rate every 6weeks since thoracic irradiation.

To evaluated in the 36 weeks since the thoracic irradiation began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Shanghai Pulmonary Hospital, Shanghai, China

Tongji University

Professor, doctor

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Menopause

Herbal and Botanical

Black Cohosh

Using Remifemin during LHRH-a treatment in breast cancer

No intervention during LHRH-a treatment in breast cancer

Remifemin 0.2g po bid\*12 weeks at the beginning of the LHRH-a treatment

Remifemin

Xingfei Yu

LHRH-a is an important hormone treatment in breast cancer especially in high-risk hormone receptor-positive patients or hormone receptor-negative but needing ovarian function protecting. The climacteric symptoms caused by LHRH-a are often and prominent, which is a common clinical problem.

Ovarian function suppression (OFS) or protection has been studied widely in breast cancer. As an common drug in clinic, LHRH-a is an important method for OFS in breast cancer especially in high-risk hormone receptor-positive patients or hormone receptor-negative but needing ovarian function protecting. The climacteric symptoms caused by LHRH-a are often and prominent, which is a common clinical problem. Remifemin (cimicifuga racemosa / black cohosh) is effective in climacteric symptoms as a hormone replacement treatment, some research concluded that it is also safe in breast cancer patients who are postmenopausal or taking tamoxifen suffering from climacteric symptoms. While in China, more than 2/3 breast cancer patients are pre/peri-menopause, and some part of them should take OFS as an hormone treatment. OFS can cause sever climacteric symptoms in a short time. The investigators aim to estimate the effect and safety of Remifemin in climacteric symptoms caused by OFS in breast cancer.

Remifemin Preventing the Climacteric Symptoms in Breast Cancer

The Effect of Remifemin in Preventing the Climacteric Symptoms Caused by LHRH-a Treatment in Breast Cancer: a Randomized II-stage Clinic Research

Scoring according to Kupperman item scale (Total: 0-48, the score higher the symptoms are severer) which includes of hot flash, sweat, insomnia, anxious, depressed, vertigo, fatigue, arthralgia, headache, palpitate (each item has a weighting coefficient according to four grade scores: no symptom \*0, sometimes \*1, always \*2, influent life \*3).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prevention of Locally Advanced NSCLC Radiotherapy Pneumonia by Inhaling Beclomethasone Propionate	NCT03886441	Locally Advance...	Beclomethasone ...	18 Years - 70 Years	Tongji University
Remifemin Preventing the Climacteric Symptoms in Breast Cancer	NCT03339882	Effect of Drugs Safety Issues	Remifemin	18 Years - 55 Years	Zhejiang Cancer Hospital
Prevention of Locally Advanced NSCLC Radiotherapy Pneumonia by Inhaling Beclomethasone Propionate	NCT03886441	Locally Advance...	Beclomethasone ...	18 Years - 70 Years	Tongji University

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