Clinical trial NCT05852002: A Clinical Study of Pain and Discomfort Associated With Advanced Lung Cancer
Official title: A Clinical Study of 35 kDa Hyaluronan Fragment in Treatment of Pain and Discomfort Associated With Advanced Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Lung Cancer
Keywords: 35kDa hyaluronan fragment
palliative care
pain and discomfort
cough
fatigue
Lead sponsor: Nakhia Impex LLC
Sponsor class: INDUSTRY
Collaborators: name: Mongolian National University of Medical Sciences
First posted: 2023-05-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: A pain scale
timeFrame: twenty eight days
measure: Respiratory symptom cough
timeFrame: twenty eight days
measure: Fatigue
timeFrame: twenty eight days
measure: The degree of facial skin brightness and facial expression or spirit
timeFrame: twenty eight days
measure: chest CT scans
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ulaanbaatar
country: Mongolia
facility: Mongolian National University of Medical Sciences
Study officials:
References: