35kDa Hyaluronan Fragment Treatment of Colorectal and Rectal Cancer

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

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).

Study Overview

• Status: Completed
• Conditions: Cancer Pain
• Intervention / Treatment: Drug: HA35

Detailed 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.

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

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China
      • Qingdao Huinorde Science and Technology Co.,Ltd

Participation Criteria

Eligibility Criteria

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

Description

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

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: 35kDa hyaluronan fragment HA35 injection; A total of 2000 units of bovine testis hyaluronidase PH20 (hyaluronidase for injection H31022111, P.R.C) and 100 mg high molecular weight HA (sodium hyaluronate for injection, H20174089, P.R.C) were mixed at room temperature for 20 minutes, then was locally injected into patient's abdominal deep fat layer by a registered nurse or a physician in order to quickly alleviate pain associated with radiotherapy for treatment colorectal and rectal cancer.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nakhia Impex LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): March 5, 2024

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: January 14, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: colorectal cancer; pain; rectal cancer; 35kDa hyaluronan fragment
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Cancer Pain
• Other Study ID Numbers: H20231218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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