Sponsored by Nakhia Impex LLC

Advancing Care for Radiotherapy Recovery

Join a clinical research study evaluating a new approach for managing pain associated with radiotherapy in colorectal and rectal cancer patients. Your participation helps advance medical science.

Ages 48-60
Phase 1 Study
Select Clinics
Actively Enrolling

Study Protocol HA35

Evaluating 35kDa Hyaluronan Fragment treatment efficacy and pain reduction post-radiotherapy.

72-hour monitoring
Clinical assessment
Patient Safety FirstIRB Approved Protocol
About the Study

35kDa Hyaluronan Fragment Treatment for Colorectal & Rectal Cancer

Study Purpose

This clinical research study investigates the potential of HA35 (Bioactive HA), a specialized hyaluronan fragment known for its excellent tissue permeability, to provide analgesic relief and understand its potential anticancer effects.

Condition Addressed

This research is designed specifically for individuals diagnosed with Colorectal and Rectal Cancer who are currently experiencing pain associated with targeted radiotherapy treatments.

How It Works

Previous research has demonstrated that hyaluronan and its fragments can modulate pain receptors, effectively reducing peripheral nociceptor activity. In this study, participants receive a carefully prepared HA35 injection to address inflammatory and neuropathic pain.

What to Expect

  • Administration of the HA35 treatment injection by our clinical team.
  • Pain levels carefully monitored and assessed at 1, 3, 24, 48, and 72-hour intervals.
  • Continuous oversight by dedicated medical professionals prioritizing your safety.

Study Eligibility

Review the criteria below to see if this colorectal and rectal cancer pain management study might be a right fit for you.

You May Qualify If You:

  • Are between 48 and 60 years of age
  • Have recently undergone targeted radiotherapy
  • Have varying degrees of cancer metastasis (including bone metastasis)
  • Are able to use prescribed antibiotics during treatment, if needed

You May Not Qualify If You:

  • Are unable to independently assess or communicate your pain level
  • Are currently experiencing severe bleeding or severe inflammation

Not sure if you qualify? Take our quick eligibility quiz to find out.

Study Participation Benefits

Understanding what this study provides for participants. All study-related care, treatments, and assessments are provided at no cost.

Investigational Treatment

Access to the HA35 injection at no cost, which is being carefully evaluated for its potential to treat pain associated with targeted radiotherapy.

Close Medical Monitoring

Receive regular pain assessments and comprehensive health evaluations at specific intervals (up to 72 hours) by our specialized research team.

Specialized Care Team

Get focused attention and ongoing care from medical professionals dedicated to advancing treatments for colorectal and rectal cancer.

Study Information

Frequently Asked Questions

Find clear, transparent answers about the HA35 Colorectal & Rectal Cancer pain management study.

What is a clinical trial and is it safe?

A clinical trial is a carefully designed research study that explores whether a medical strategy, treatment, or device is safe and effective for humans. Patient safety is our absolute highest priority. This study is strictly monitored by medical professionals and regulatory boards to ensure all ethical and safety standards are continuously met.

How long will I be in the study?

For this specific HA35 study, your pain levels will be formally assessed at specific intervals following the injection: 1 hour, 3 hours, 24 hours, 48 hours, and 72 hours. Your total time commitment, including pre-screening and follow-up visits, will be thoroughly detailed by the study doctor before you decide to participate.

What are the possible risks and side effects?

All medical treatments carry some level of risk. While HA35 has shown good tissue permeability and safety in previous applications, potential side effects will be transparently explained by our medical team. You will be closely monitored by healthcare professionals throughout the entire process to ensure your well-being.

Will my information be kept confidential?

Absolutely. Your privacy is protected by strict healthcare laws. Any data shared with the study sponsor, Nakhia Impex LLC, or regulatory bodies will be strictly anonymized. Your personal identity will never be published or shared outside of the direct care team without your explicit consent.

Can I leave the study if I change my mind?

Yes. Participation in any clinical trial is entirely voluntary. You have the right to withdraw from the study at any time, for any reason. Choosing to leave will not affect your regular medical care, your relationship with your doctor, or your access to standard treatments.

Will I receive the actual medication or a placebo?

This study evaluates the effectiveness of freshly made HA35 injections for treating pain associated with radiotherapy. The study team will clearly explain the specific treatment arms, how assignments are made, and whether a placebo control group is involved during your initial screening consultation.

What happens after the study ends?

Once the study concludes, the collected data is analyzed to help advance medical understanding of pain management in colorectal cancer patients. You will return to the care of your primary physician or oncologist, who will advise you on the best next steps for your ongoing treatment plan.