35kDa Hyaluronan Fragment Treatment of Colorectal and Rectal Cancer

NCT06209970 | Completed

• 1 other identifier: H20231218
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cancer Pain

Keywords

35kDa hyaluronan fragment; pain; colorectal cancer; rectal cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

35kDa hyaluronan fragment HA35 injection

EXPERIMENTAL

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

Interventions

HA35 DRUG

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.

35kDa hyaluronan fragment HA35 injection

Eligibility Criteria

• Age: 48 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nakhia Impex LLC: lead

Study Sites (1)

Qingdao Huinorde Science and Technology Co.,Ltd

Qingdao, Shandong, China

Location

MeSH Terms

Conditions

Cancer Pain; Pain; Colorectal Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

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: December 18, 2023
• First Posted: January 18, 2024
• Study Start: December 20, 2023
• Primary Completion: February 1, 2024
• Study Completion: March 5, 2024
• Last Updated: April 17, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)