35kDa Hyaluronan Fragment Treatment of Colorectal and Rectal Cancer

N/ACompletedNCT06209970

Nakhia Impex LLC10 enrolled

Overview

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).

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer Pain

Interventions

HA35DRUG

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.

Eligibility

Sex: ALLMin age: 48 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Qingdao Huinorde Science and Technology Co.,Ltd

Qingdao, Shandong, China

Outcomes

Primary Outcomes

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.

Time frame: 1 hour, 3 hours, 24 hours, 48 hours and 72 hours

Data from ClinicalTrials.gov

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