Cancer Pain
Conditions
Keywords
35kDa hyaluronan fragment, pain, colorectal cancer, rectal cancer
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.
Interventions
DRUGHA35
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.
Sponsors
Nakhia Impex LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
48 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed