Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT05852002
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2023-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study of Pain and Discomfort Associated With Advanced Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D003371', 'term': 'Cough'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-14', 'studyFirstSubmitDate': '2023-05-01', 'studyFirstSubmitQcDate': '2023-05-01', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A pain scale', 'timeFrame': 'twenty eight days', 'description': '0 represents no pain or discomfort , while 10 represents the most serious pain or discomfort.'}, {'measure': 'Respiratory symptom cough', 'timeFrame': 'twenty eight days', 'description': '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.'}, {'measure': 'Fatigue', 'timeFrame': 'twenty eight days', 'description': '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.'}, {'measure': 'The degree of facial skin brightness and facial expression or spirit', 'timeFrame': 'twenty eight days', 'description': '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.'}, {'measure': 'chest CT scans', 'timeFrame': '3 months', 'description': 'namely "significant reduction" or "significant increase" or "no significant changes" in lung tumor mass.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['35kDa hyaluronan fragment', 'palliative care', 'pain and discomfort', 'cough', 'fatigue'], 'conditions': ['Advanced Lung Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nPalliative 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.\n\nThe 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.\n\nWhile 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.\n\nHyaluronidase 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>=18 years old\n* Sign the informed consent form voluntarily.\n* Expected survival ≥3 months.\n* 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.\n* The subject has good compliance and cooperates with the follow-up.\n\nExclusion Criteria:\n\n* Subjects who are receiving systematic steroid treatments before the first cell treatment.\n* Subjects with a history of mental disorders or drug abuse that may influence treatment compliance.\n* Women in pregnancy or lactation or are expected to be pregnant during the study.'}, 'identificationModule': {'nctId': 'NCT05852002', 'briefTitle': 'A Clinical Study of Pain and Discomfort Associated With Advanced Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nakhia Impex LLC'}, 'officialTitle': 'A Clinical Study of 35 kDa Hyaluronan Fragment in Treatment of Pain and Discomfort Associated With Advanced Lung Cancer', 'orgStudyIdInfo': {'id': 'HSHN004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '35 kDa hyaluronan fragment injection', 'description': '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.', 'interventionNames': ['Drug: 35 kDa hyaluronan fragment']}], 'interventions': [{'name': '35 kDa hyaluronan fragment', 'type': 'DRUG', 'otherNames': ['B-HA'], 'description': '100 mg of 35kDa hyaluronan fragment was injected deeply into abdominal fat layer once a day for 28 consecutive days.', 'armGroupLabels': ['35 kDa hyaluronan fragment injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ulaanbaatar', 'country': 'Mongolia', 'facility': 'Mongolian National University of Medical Sciences', 'geoPoint': {'lat': 47.90771, 'lon': 106.88324}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nakhia Impex LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Mongolian National University of Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}