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临床试验/NCT05852002
NCT05852002已完成不适用

A Clinical Study of 35 kDa Hyaluronan Fragment in Treatment of Pain and Discomfort Associated With Advanced Lung Cancer

Nakhia Impex LLC1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年4月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
A pain scale

研究概览

简要总结

In this research, the patients with advanced lung cancer accompanied by pain and discomfort were treated by injecting freshly manufactured tissue permeable hyaluronan fragment HA35 into the tissue under abdominal adipose.

详细描述

Pain is generally considered the most common symptom of lung cancer. The three most common causes of pain in patients with advanced lung cancer are: 1. metastasis of lung cancer to the bones, which accounts for approximately 34 percent of lung cancer pain; 2. Presence of a Pancoast tumor, located at the top of the lung close to the brachial plexus nerves and cervical sympathetic nerves, which accounts for approximately 31 percent of lung cancer pain; 3. Spread of the cancer into the chest wall, accounting for approximately 21 percent of lung cancer pain.

Palliative care is a specialized field that aims to alleviate symptoms and maximize the patient's quality of life. Palliative care does not focus on curing the disease or prolonging life, which is the goal of other cancer treatments, such as chemotherapy. However, palliative care is an important part of the patient's treatment plan and encompasses physical symptoms, psychosocial distress, spiritual distress, and caregiver distress.

The management of pain due to lung cancer may include a combination of medications, such as non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, opioids (pain medications), and antidepressants. For metastases to the bone, radiation therapy and the use of bisphosphonates (drugs to help prevent bone breakdown) can alleviate pain. In addition, smoking cessation (stopping smoking) is recommended, as surveys have revealed that lung cancer patients who continue to smoke after diagnosis have a higher incidence of pain and other lung cancer complications than nonsmokers and those who quit smoking.

While pain is the most common symptom of lung cancer, other symptoms include: persistent coughing,wheezing,shortness of breath,hoarseness,weight loss,loss of appetite,fatigue or feeling weak and respiratory infections (like bronchitis or pneumonia) that don't go away or keep returning.

Hyaluronidase PH20 produced 35 kDa tissue permeable low molecular weight hyaluronan fragment by cutting high molecular hyaluronan. The previous clinical studies had shown that local injection of 35 kDa hyaluronan fragment effectively relieved inflammatory pain and neuropathic pain and promoted chronic wound healing.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age>=18 years old
  • Sign the informed consent form voluntarily.
  • Expected survival ≥3 months.
  • Pathologically confirmed locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), which is currently not suitable for local treatment such as radical surgery or radiotherapy.
  • The subject has good compliance and cooperates with the follow-up.

排除标准

  • Subjects who are receiving systematic steroid treatments before the first cell treatment.
  • Subjects with a history of mental disorders or drug abuse that may influence treatment compliance.
  • Women in pregnancy or lactation or are expected to be pregnant during the study.

研究组 & 干预措施

35 kDa hyaluronan fragment injection

Experimental

35kDa hyaluronan fragment was produced by using hyaluronidase PH20 to cleave 1600kDa hyaluronan ( HA1600 ). Batch number of 35 kDa hyaluronan fragment injection is L20200708MP07707,and the injection was approved by Ministry of Health, Mongolia.

干预措施: 35 kDa hyaluronan fragment (Drug)

结局指标

主要结局

A pain scale

时间窗: twenty eight days

0 represents no pain or discomfort , while 10 represents the most serious pain or discomfort.

Fatigue

时间窗: twenty eight days

A modified pain scale was used to assess fatigue associated with advanced lung cancer. 0 represents no fatigue while 10 represents the most severe fatigue.

chest CT scans

时间窗: 3 months

namely "significant reduction" or "significant increase" or "no significant changes" in lung tumor mass.

Respiratory symptom cough

时间窗: twenty eight days

A modified pain scale was used to assess respiratory symptom cough associated with advanced lung cancer. 0 represents no cough while 10 represents the most severe cough.

The degree of facial skin brightness and facial expression or spirit

时间窗: twenty eight days

A modified pain scale was used to assess the degree of facial skin brightness and facial expression or spirit associated associated with advanced lung cancer. 0 represents the best degree of facial skin brightness while 10 represents the worst degree of facial skin brightness; 0 represents the best degree of facial expression or spirit while 10 represents the worst degree of facial expression or spirit.

次要结局

未报告次要终点

研究者

发起方
Nakhia Impex LLC
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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