Advanced Lung CancerNCT05852002
A Clinical Study of Pain and Discomfort Associated With Advanced Lung Cancer
A study testing 35 kDa hyaluronan fragment in people with Advanced Lung Cancer, run by Nakhia Impex LLC at 1 site in Mongolia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Lung Cancer
- What is being tested?
- 35 kDa hyaluronan fragment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteMongolia
- Study dates
- 11 Apr 2023to 12 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study of 35 kDa Hyaluronan Fragment in Treatment of Pain and Discomfort Associated With Advanced Lung Cancer
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.
Read the 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.
- Conditions
- Advanced Lung Cancer
- Being tested
- 35 kDa hyaluronan fragment
- Keywords
- 35kDa hyaluronan fragment, palliative care, pain and discomfort, cough, fatigue
- Medical subject headings
- Pain, Cough, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
35 kDa hyaluronan fragmentDrug
Also called B-HA
100 mg of 35kDa hyaluronan fragment was injected deeply into abdominal fat layer once a day for 28 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 35 kDa hyaluronan fragment |
What is being measured
The primary outcome is the main question the study is designed to answer.
A pain scale
0 represents no pain or discomfort , while 10 represents the most serious pain or discomfort.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: twenty eight days
chest CT scans
namely "significant reduction" or "significant increase" or "no significant changes" in lung tumor mass.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start11 Apr 2023
- Primary completion1 Nov 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nakhia Impex LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mongolian National University of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852002
- Sponsor's protocol ID
- HSHN004
- Status last verified
- Apr 2023
- First submitted
- 1 May 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of 35 kDa Hyaluronan Fragment in Treatment of Pain and Discomfort Associated With Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT05852002
- Acronym / sponsor ID
- HSHN004
- Conditions
- Advanced Lung Cancer
- Keywords
- 35kDa hyaluronan fragment, palliative care, pain and discomfort, cough, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nakhia Impex LLCIndustry (pharma, biotech, devices)
- Collaborators
- Mongolian National University of Medical Sciences
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 35 kDa hyaluronan fragment injection | Experimental | Drug: 35 kDa hyaluronan fragment35kDa 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 35 kDa hyaluronan fragmentAlso: B-HA100 mg of 35kDa hyaluronan fragment was injected deeply into abdominal fat layer once a day for 28 consecutive days. | Drug | 35 kDa hyaluronan fragment injection |
Primary outcome
A pain scale
Time frame: twenty eight days
0 represents no pain or discomfort , while 10 represents the most serious pain or discomfort.
Respiratory symptom cough
Time frame: 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.
Fatigue
Time frame: 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.
The degree of facial skin brightness and facial expression or spirit
Time frame: 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.
chest CT scans
Time frame: 3 months
namely "significant reduction" or "significant increase" or "no significant changes" in lung tumor mass.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 35 kDa hyaluronan fragment in people with Advanced Lung Cancer, run by Nakhia Impex LLC at 1 site in Mongolia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mongolia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A pain scale (time frame: twenty eight days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.