EUCTR2008-005565-54-SK进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, parallel-group phase III clinical study to assess the efficacy and safety of soluble beta 1,3/1,6 glucan (SBG) on oral mucositis in head and neck cancer patients undergoing radiation therapy with or without chemotherapy
Biotec Pharmacon ASA0 个研究点目标入组 120 人开始时间: 2008年11月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.=18 years of age;
- •2.Patients with histologically confirmed carcinoma of the oral cavity, oropharynx, hypopharynx, supraglottic larynx, salivary glands or maxillary sinus;
- •3.Scheduled to receive an either conventional or altered fractionation external beam radiotherapy regimen for their head and neck cancer with or without concurrent chemotherapy;
- •4.At least two visible oral cavity anatomical sites must be included in the radiotherapy treatment volume and planned to receive a total radiation dose of 54 Gy or higher;
- •5.Normal oral mucosa at baseline (i.e. National Cancer Institute Common Toxicity Criteria [NCI-CTC] oral mucositis grade 0);
- •6.Karnofsky score performance status =70%
- •7.Female patients must have a negative serum pregnancy test prior to receiving study medication, unless they have had a hysterectomy, or have been post-menopausal for at least 1 year. Women with child bearing capacity must agree to use a medically accepted form of contraception throughout the study period;
- •8.Willing and able to provide written informed consent for study participation;
- •9.Willing and able to complete other protocol-specified evaluations according to the study schedule.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Previous head and neck cancer;
- •2.History of, or clinical evidence of active significant acute or chronic conditions that may compromise the ability to evaluate or interpret the effects of the study treatment on mucositis:
- •i.Symptomatic and/or uncontrolled cardiac disease, New York Heart Association (NYHA) grade III/IV, transmural myocardial infarction or stroke within the last 6 months;
- •ii.Known sero-positivity for hepatitis B or hepatitis C virus (testing not required for study entry);
- •iii.Known sero-positivity for human immunodeficiency virus (HIV) or patients with acquired immune deficiency syndrome (AIDS) (testing not required for study entry);
- •iv.Acute bacterial or fungal infection requiring intravenous antibiotics at study entry;
- •v.Immunology disorders such as scleroderma or any other medical condition requiring chronic use of systemic corticosteroids.
- •3.Patients expected to receive other oral mucositis treatment or preventative agents during the study as described in Section ?7.3 Prohibited Medication;
- •4.Patients who received previous radiotherapy in the head and neck area;
- •5.Patients who received chemotherapy within the past 6 months before screening;
- •6.Receipt of any investigational product within 30 days prior to this study;
- •7.Any patient who, in the opinion of the Investigator, is unlikely to comply with the study procedures, or is unlikely to complete the study due to different reasons e.g. language barriers or mental incapacity;
- •8.Pregnancy or breastfeeding.
研究者
相似试验
进行中（未招募）
Unknown
actoSpore® as an adjuvant in the treatment of Bacterial VaginosisCTRI/2023/05/052560Sami Sabinsa Group Limited
进行中（未招募）
1 期
Efficacy and safety of dexketoprofen trometamol and tramadol hydrochloride combination on moderate to severe acute pain in patients with acute low back paiow back painMedDRA version: 21.0Level: LLTClassification code 10024891Term: Low back painSystem Organ Class: 100000004859EUCTR2019-003656-37-HRMenarini International Operations Luxembourg SA510
进行中（未招募）
不适用
A randomized, double-blind, placebo-controlled, parallel group study to investigate the safety and tolerability of 14-days treatment with an inhaled dose of QMF149 (500/800) in mild to moderate asthmatic patients.asthmaEUCTR2007-004608-11-FRovartis Pharma Services AG28
已完成
不适用
Boswellia serrata extract 200 mg capsules in subject with Irritable Bowel Syndrome.CTRI/2019/11/022190Inventia Healthcare Limited50
进行中（未招募）
不适用
A randomized, double-blind, placebo-controlled, parallel group study to evaluate the effects of a 4-week treatment of 30 mg b.i.d BIBW 2948 BS (inhalation powder, hard capsule for HandiHaler®) on epithelial mucin stores and the safety and efficacy in COPD patients with symptoms associated with chronic bronchitis - Effects of BIBW 2948 on epithelial muciEUCTR2006-001975-40-IEBoehringer Ingelheim Limited60