35kDa Hyaluronan Fragment Treatment of Colorectal and Rectal Cancer

Cancer Pain Clinical Trial

Official title:

Injection of 35kDa Hyaluronan Fragment Alleviates Pain Associated With Radiotherapy for Treatment of Colorectal and Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06209970
• Other study ID #: H20231218
• Status: Completed
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: March 5, 2024

Study information

• Verified date: December 2023
• Source: Nakhia Impex LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

HA35 (Bioactive HA or B-HA or HA35) have good tissue permeability (B-HA injection, Ministry of Health, Registration number L20200708MP07707). HA35 might not lose HA's bioactivities of binding to a variety of hyaluronan's binding proteins or receptors, including the analgesic and anticancer effects of hyaluronan, therefore being named bioactive HA or B-HA (10) (B-HA injection, Ministry of Health, Registration number L20200708MP07707).

Description:

The previous study has shown that naked mole rat who has high tissue content of hyaluronan and its fragments is insensitive to pain. The previous study has also shown that hyaluronan modulates pain-regulated TRPV1 channel opening, reducing peripheral nociceptor activity and pain. The previous study has again shown that local injection of 35kDa hyaluronan fragment HA35 is effective in treating inflammatory and neuropathic pain. This study employs freshly made HA35 injection for treatment of pain associated with radiotherapy for treatment of colorectal and rectal cancer. A numerical rating scale from 0 to 10 was used to assess the pain after 1 hour, 3 hours, 24 hours, 48 hours and 72 hours of the injection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 5, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 48 Years to 60 Years

Eligibility

Inclusion Criteria:

• All patients had different degrees of metastasis of the cancers, including bone metastasis.
• All patients undergo targeted radiotherapy shortly before this study.
• All the patient volunteers included in this study were allowed to use antibiotic compounds on and off during the treatment in order to prevent possible infection associated with the cancers for ethnic consideration.
• The included patients were aged 48 to 60 years.

Exclusion Criteria:

• Can not independently determine the level of pain.
• Severe bleeding and severe inflammation

Related Conditions & MeSH terms

• Cancer Pain
• Rectal Neoplasms

Intervention

Drug:
• HA35
All the freshly made HA35 or B-HA samples were diluted to a final concentration of 5 mg/ml. The filter membrane with 220nm pore size was used to filter freshly made HA35 or B-HA injection in order to test its human tissue permeability as <220nm nino-particle.

Locations

Country	Name	City	State
China	Qingdao Huinorde Science and Technology Co.,Ltd	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Nakhia Impex LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rating Scale	A numerical rating scale (NRS) from 0 to 10 was used to assess the pain after 1 hour, 3 hours, 24 hours, 48 hours and 72 hours of the injection. Each patient rates their pain on a scale of 0 to 10, where a score of 0 means "no pain" and 10 means "the most painful". More specifically, 0 points indicates no pain; 1-3 points can be interpreted as slight and bearable pain; 4-6 points can be interpreted as pain that affects sleep but is still tolerable; and 7-10 points can be interpreted as intense and unbearable pain that affects sleep or other activities.	1 hour, 3 hours, 24 hours, 48 hours and 72 hours