NCT05852002

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2023

Completed
Last Updated

January 17, 2024

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

May 1, 2023

Last Update Submit

January 14, 2024

Conditions

Advanced Lung Cancer

Keywords

35kDa hyaluronan fragmentpalliative carepain and discomfortcoughfatigue

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

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.

Drug: 35 kDa hyaluronan fragment

Interventions

35 kDa hyaluronan fragmentDRUG

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
35 kDa hyaluronan fragment injection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mongolian National University of Medical Sciences

Ulaanbaatar, Mongolia

Location

MeSH Terms

Conditions

PainCoughFatigue

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, Respiratory

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2023

First Posted

May 10, 2023

Study Start

April 11, 2023

Primary Completion

November 1, 2023

Study Completion

December 12, 2023

Last Updated

January 17, 2024

Record last verified: 2023-04

Locations

MO(1)