AM RF EMF + Fruquintinib for Colon Cancer

Recruiting at 8 trial locations

Overseen By Mohammed Najeeb Al Hallak, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Barbara Ann Karmanos Cancer Institute

Must not be taking: QT prolonging drugs, Calcium channel blockers

Disqualifiers: Uncontrolled hypertension, Cardiovascular disease, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 year

102 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining Fruquintinib with a special device using radio waves (AM RF EMF) can extend the lives of people with advanced colon cancer. The focus is on individuals whose cancer has not improved with standard treatments like chemotherapy. The trial seeks participants with confirmed metastatic colon cancer who have not responded well to other treatments and possess a specific genetic profile. Participants should have manageable health issues and be willing to adhere to the trial's guidelines. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop taking my current medications to join the trial?

The trial requires you to stop taking certain medications, such as those that affect calcium channels, at least 7 days before starting treatment. You also need to avoid medications that prolong the QT interval or interact with CYP3A4 enzymes. It's best to discuss your current medications with the trial team to see if any need to be stopped.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that treatments using certain types of radio waves are safe for humans. The energy levels used remain well below international safety limits, ensuring the treatment's safety for the body.

Research indicates that Fruquintinib is well-tolerated by patients with advanced colorectal cancer. Studies have found it does not increase the risk of serious side effects, suggesting Fruquintinib's safety for these patients.

Overall, past research has found both treatments to be safe with manageable side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for colon cancer?

Unlike the standard treatments for colon cancer, which typically involve chemotherapy and targeted therapies, the combination of amplitude-modulated radiofrequency electromagnetic fields with Fruquintinib offers a unique approach. Fruquintinib is a small molecule inhibitor that specifically targets vascular endothelial growth factor receptors (VEGFRs), which are involved in tumor blood vessel formation. The innovative addition of amplitude-modulated radiofrequency electromagnetic fields is believed to enhance the efficacy of Fruquintinib by potentially disrupting cancer cell signaling and growth patterns. Researchers are excited about this treatment because it could offer a more targeted attack on cancer cells, potentially leading to improved outcomes for patients with colon cancer.

What evidence suggests that AM RF EMF plus Fruquintinib could be effective for colon cancer?

Research has shown that certain radio waves, known as amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF), can combat cancer. Studies in colorectal cancer have found that these radio waves affect tumor cells without causing heat damage. Meanwhile, the drug Fruquintinib has shown promise in treating advanced colorectal cancer by extending patient survival and delaying cancer progression. In one study, patients taking Fruquintinib lived for an average of 11.4 months, longer than those who took a placebo. This trial will evaluate the combination of AM RF EMF and Fruquintinib, potentially offering a better option for people with advanced colorectal cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Mohammed Najeeb Al Hallak, MD

Principal Investigator

Wayne State University

Are You a Good Fit for This Trial?

This trial is for adults aged 22 or older with metastatic colorectal cancer that hasn't improved after treatments including chemotherapy and anti-VEGF/anti-EGFR therapies. They must have a certain level of physical fitness (ECOG 0-2), weigh at least 40 kg, have tumors visible on scans, and be expected to live more than 12 weeks.

Inclusion Criteria

My colorectal cancer is confirmed and tested for RAS, BRAF, MSI/MMR, and HER2.

I have received chemotherapy that includes drugs like 5-FU, oxaliplatin, or irinotecan.

My disease can be measured or seen on a CT, MRI, or PET scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TheraBionic P1 amplitude-modulated radiofrequency electromagnetic fields device 3 times daily plus Fruquintinib daily (3 weeks on and 1 week off)

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF)
• Fruquintinib

Trial Overview The study tests if using AM RF EMF (a type of electromagnetic field therapy) alongside Fruquintinib can extend survival in patients with tough-to-treat colon cancer. It's about finding out if this combo is effective and can be tolerated by patients.

How Is the Trial Designed?

Group I: Amplitude-modulated radiofrequency electromagnetic fields device plus Fruquintinib Experimental Treatment 2 Interventions

TheraBionic P1 amplitude-modulated radiofrequency electromagnetic fields device 3 times daily (continuous) plus Fruquintinib daily (3 weeks on and 1 week off)

Who Is Running the Clinical Trial?

Barbara Ann Karmanos Cancer Institute

Lead Sponsor

Trials

166

Recruited

9,300+

THERABIONIC INC.

Collaborator

Trials

3

Recruited

210+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9655505/

Radiofrequency Electromagnetic Fields Cause Non ... We could demonstrate in a colorectal cancer model that radiofrequency electromagnetic fields do have anticancer effects when not being induced ...

2. ancora.ai ancora.ai/en/details/NCT07130903

Amplitude-Modulated Radiofrequency Electromagnetic ... The goal of this clinical trial is to learn if adding amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) to Fruquintinib ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2672058/

Amplitude-modulated electromagnetic fields for the treatment ... We undertook this study to identify tumor-specific frequencies and test the feasibility of administering such frequencies to patients with advanced cancer.

4. nature.com nature.com/articles/s41598-020-69561-3

Non-thermal effects of radiofrequency electromagnetic fields We verified the non-thermal effects of RF-EMF on colon cancer cell lines and established an electrophysiological model of the cell membrane ...

5. researchgate.net researchgate.net/publication/364969391_Radiofrequency_Electromagnetic_Fields_Cause_Non-Temperature-Induced_Physical_and_Biological_Effects_in_Cancer_Cells

(PDF) Radiofrequency Electromagnetic Fields Cause Non- ... Here, we established measurement techniques to prove their existence by investigating energy deposition in tumor cells under RF exposure and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07130903

Study Details | NCT07130903 | Amplitude-Modulated ... Effective in improving survival; safe and tolerable. Official Title. A Phase 2 Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3845545/

Targeted treatment of cancer with radiofrequency ... In summary, our clinical results provide strong evidence that the intrabuccal administration of RF EMF amplitude-modulated at tumor-specific frequencies is safe ...

8. mdpi.com mdpi.com/2072-6694/14/21/5349

Radiofrequency Electromagnetic Fields Cause Non- ... We could demonstrate in a colorectal cancer model that radiofrequency electromagnetic fields do have anticancer effects when not being induced by increased ...

9. frontiersin.org frontiersin.org/journals/medical-technology/articles/10.3389/fmedt.2022.869155/full

Low-energy amplitude-modulated radiofrequency ... In this review, we focus on medical devices that deliver low-power EMFs with a carrier wave frequency of 27.12 MHz, amplitude-modulated at multiple tumour type- ...

10. ascopubs.org ascopubs.org/doi/10.1200/JCO.2018.36.4_suppl.332

Amplitude-modulated radiofrequency electromagnetic ... Conclusions: Whole-body SAR ranges from 0.2 to 1 mW/kg and is significantly below the international safety limits for human exposure. Intrabucally-administered ...