35kDa Hyaluronan Fragment Treatment of Colorectal and Rectal Cancer

Not Applicable

Completed

• Conditions: Cancer Pain
• Interventions: Drug: HA35

• Registration Number: NCT06209970
• Lead Sponsor: Nakhia Impex LLC

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).

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 Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-18
• Study Start: 2023-12-20
• Study First Submitted QC: 2024-01-14
• Study First Posted: 2024-01-18
• Primary Completion: 2024-02-01
• Study Completion: 2024-03-05
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
35kDa hyaluronan fragment HA35 injection	HA35	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.

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale	1 hour, 3 hours, 24 hours, 48 hours and 72 hours	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.

Trial Locations

Locations (1)

Qingdao Huinorde Science and Technology Co.,Ltd; 🇨🇳 Qingdao, Shandong, China