An interventional study of 35 kDa hyaluronan fragment in Advanced Lung Cancer, sponsored by Nakhia Impex LLC. Completed at 1 site in Mongolia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-01-17.
Sponsored by Nakhia Impex LLC · Not applicable, Interventional, and Treatment
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.
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 10 is below the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Nakhia Impex LLC is the lead sponsor of 15 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: 35 kDa hyaluronan fragment
100 mg of 35kDa hyaluronan fragment was injected deeply into abdominal fat layer once a day for 28 consecutive days.
Also known as: B-HA
A pain scale
0 represents no pain or discomfort , while 10 represents the most serious pain or discomfort.
Time frame: twenty eight days
Respiratory symptom cough
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.
Time frame: twenty eight days
Fatigue
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.
Time frame: twenty eight days
The degree of facial skin brightness and facial expression or spirit
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.
Time frame: twenty eight days
chest CT scans
namely "significant reduction" or "significant increase" or "no significant changes" in lung tumor mass.
Time frame: 3 months
Ran from Apr 2023 to primary completion in Nov 2023, 6 months.
Of 99 industry-sponsored interventional studies with no phase under Pain, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 30. This study's 6 months is below that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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