A Clinical Study of Pain and Discomfort Associated With Advanced Lung Cancer

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.

Study Overview

• Status: Completed
• Conditions: Advanced Lung Cancer
• Intervention / Treatment: Drug: 35 kDa hyaluronan fragment

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mongolia
  • Ulaanbaatar, Mongolia
    • Mongolian National University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 35 kDa hyaluronan fragment injection; 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.; Other Names: B-HA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A pain scale	0 represents no pain or discomfort , while 10 represents the most serious pain or discomfort.	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.	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.	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.	twenty eight days
chest CT scans	namely "significant reduction" or "significant increase" or "no significant changes" in lung tumor mass.	3 months

Collaborators and Investigators

• Sponsor: Nakhia Impex LLC
• Collaborators: Mongolian National University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2023
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 14, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: palliative care; fatigue; cough; pain and discomfort; 35kDa hyaluronan fragment
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: HSHN004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No