Ultrasound for Detecting Chemotherapy-Induced Peripheral Neuropathy

Overseen By Ashley Fansler, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must be taking: Oxaliplatin

Disqualifiers: Pre-existing neuropathy, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This pilot clinical trial studies how well ultrasound works in detecting oxaliplatin-induced neuropathy in patients with gastrointestinal cancer. Ultrasound may work better in diagnosing and detecting neuropathy in gastrointestinal cancer patients treated with the chemotherapy drug called a oxaliplatin.

Do I have to stop taking my current medications for this trial?

The protocol does not specify if you need to stop taking your current medications.

What safety data exists for using ultrasound to detect chemotherapy-induced peripheral neuropathy?

The research indicates that ultrasound has not been previously used specifically for assessing chemotherapy-induced peripheral neuropathy, particularly from oxaliplatin. However, ultrasound is an emerging technique in the study of peripheral nerve diseases. The safety data for oxaliplatin itself highlights that it causes peripheral neuropathy, which is a major adverse effect and dose-limiting toxicity. While ultrasound has been evaluated for taxane-induced neuropathy, specific safety data for its use in detecting oxaliplatin-induced neuropathy is not detailed in the provided research. ^{1 2 3 4 5}

Is the drug Oxaliplatin a promising treatment for chemotherapy-induced peripheral neuropathy?

The research does not suggest that Oxaliplatin is a promising treatment for chemotherapy-induced peripheral neuropathy. Instead, it indicates that Oxaliplatin can cause this condition, and ultrasound is being explored as a way to detect the nerve damage it causes. ^{1 4 6 7 8}

What data supports the idea that Ultrasound for Detecting Chemotherapy-Induced Peripheral Neuropathy is an effective treatment?

The available research shows that ultrasound is being explored as a tool to assess chemotherapy-induced peripheral neuropathy, but there is no direct evidence in the provided information that it is an effective treatment. Instead, ultrasound is used as a diagnostic method to evaluate nerve damage caused by chemotherapy. It helps in identifying and monitoring the condition, which can be crucial for managing symptoms and adjusting treatment plans. However, the research does not compare ultrasound to other treatments or provide specific data on its effectiveness as a treatment itself. ^{1 2 4 6 9}

Who Is on the Research Team?

Roy E. Strowd

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for patients with any stage of gastrointestinal or colorectal cancer who are currently or have previously been treated with oxaliplatin-based chemotherapy and now show signs of peripheral neuropathy. Participants must be able to understand and sign a consent form.

Inclusion Criteria

I have cancer in my digestive system.

I have been diagnosed with colorectal cancer.

I am currently or have previously been treated with oxaliplatin-based chemotherapy.

Exclusion Criteria

I cannot provide my medical or treatment history.

I had nerve damage in my hands or feet before starting oxaliplatin chemotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ultrasound Assessment

Participants undergo peripheral nerve ultrasound to assess nerve cross-sectional area

Up to 30 days

1 visit (in-person)

Follow-up

Participants are monitored for changes in nerve conduction and neuropathy symptoms

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Oxaliplatin
• Ultrasound - Serial and Tibial Nerve

Trial Overview The study is testing the effectiveness of ultrasound in detecting neuropathy caused by oxaliplatin in gastrointestinal cancer patients. It involves nerve exams, skin biopsies, nerve conduction studies, blood draws, and questionnaires about chemotherapy-induced peripheral neuropathy.

How Is the Trial Designed?

Group I: Ultrasound Experimental Treatment 6 Interventions

Undergo peripheral nerve ultrasound

Oxaliplatin is already approved in European Union, United States, Canada, Japan, Switzerland, China for the following indications:

Approved in European Union as Eloxatin for:

• Colorectal cancer

Approved in United States as Eloxatin for:

• Colorectal cancer

Approved in Canada as Eloxatin for:

• Colorectal cancer

Approved in Japan as Eloxatin for:

• Colorectal cancer

Approved in Switzerland as Eloxatin for:

• Colorectal cancer

Approved in China as Ai Heng for:

• Colorectal cancer

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 126 women treated with taxane-based chemotherapy for breast cancer, 73% reported experiencing chemotherapy-induced peripheral neuropathy (CIPN), which significantly affected their quality of life and physical functioning.

CIPN severity was notably higher in Black or African American women, indicating a need for targeted screening and intervention strategies to address this disparity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevalence and pattern of chemotherapy-induced peripheral neuropathy among women with breast cancer receiving care in a large community oncology practice. Simon, NB., Danso, MA., Alberico, TA., et al.[2022]

In a study of 186 cancer patients undergoing oxaliplatin treatment, factors such as age, gender, and performance status were significantly associated with the development of severe oxaliplatin-induced peripheral neuropathy (OIPN).

Serum levels of gamma-glutamyl transferase (GGT), vitamin D, and hemoglobin were identified as key predictors for the severity of OIPN, suggesting that these easily obtainable clinical parameters could help in assessing risk before treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive clinical factors of chronic peripheral neuropathy induced by oxaliplatin. Yildirim, N., Cengiz, M.[2021]

Chemotherapy and immunotherapy can lead to peripheral neuropathies in cancer patients, making it crucial to differentiate these from other neurological issues, which is currently challenging.

Neuromuscular ultrasound (NMUS) has shown promise as a diagnostic tool for identifying treatment-induced peripheral neurotoxicity, with new findings indicating it can detect changes in dorsal roots associated with both cytostatic and immunotherapy-induced nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of neuromuscular ultrasound in diagnostics of peripheral neuropathies induced by cytostatic agents or immunotherapies. Hartinger, S., Hammersen, J., Leistner, NA., et al.[2023]

In a study of 15 colorectal cancer patients undergoing oxaliplatin (OXL) treatment, 86.7% developed sensory axonal neuropathy, indicating that this is a common and significant side effect of OXL therapy.

Ultrasound analysis revealed increased cross-sectional area of the median and ulnar nerves at entrapment sites in 60% of patients, suggesting that OXL may increase nerve susceptibility to mechanical damage, even in those without prior neuropathy symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound assessment of oxaliplatin-induced neuropathy and correlations with neurophysiologic findings. Briani, C., Campagnolo, M., Lucchetta, M., et al.[2018]

In a study of 20 breast cancer patients experiencing moderate chemotherapy-induced peripheral neuropathy (CIPN) after taxane treatment, neuromuscular ultrasound (NMUS) revealed that the sural nerve cross-sectional area (CSA) was significantly smaller compared to healthy controls, indicating nerve damage.

The findings suggest a sensory predominant neuropathy, as a decrease in sural nerve CSA correlated with a reduction in intraepidermal nerve fiber density, highlighting the potential of NMUS as a tool for assessing CIPN and the need for further longitudinal studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular ultrasound for taxane peripheral neuropathy in breast cancer. Lycan, TW., Hsu, FC., Ahn, CS., et al.[2021]

In a study of 1313 patients with stage III colon cancer, a 3-month course of oxaliplatin-based chemotherapy significantly reduced the incidence of long-lasting peripheral sensory neuropathy (PSN) compared to a 6-month course (9.7% vs 24.3%).

The 3-month treatment duration did not compromise disease-free survival (DFS) outcomes, suggesting that a shorter course, particularly with the CAPOX regimen, may be a safer and effective option for patients, especially those with low-risk disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Long-term Peripheral Sensory Neuropathy of 3 vs 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Colon Cancer: The ACHIEVE Phase 3 Randomized Clinical Trial. Yoshino, T., Yamanaka, T., Oki, E., et al.[2022]

In a study involving 17 patients undergoing oxaliplatin chemotherapy, vibration perception threshold (VPT) was identified as the most sensitive early marker of oxaliplatin-related neuropathy, indicating its effectiveness for monitoring at low drug doses.

While nerve excitability studies showed potential for predicting neuropathy, they did not reveal significant early changes in motor axons, suggesting that VPT is a more reliable and practical tool for early detection of sensory neuropathy in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroclinical biomarkers of early peripheral neurotoxicity from oxaliplatin. McHugh, JC., Tryfonopoulos, D., Fennelly, D., et al.[2019]

In a study of 15 breast cancer patients undergoing paclitaxel treatment, clinical examinations revealed a significant increase in total neuropathy scores, indicating the development of taxane-induced polyneuropathy (TIPN) over time, particularly noticeable by 8 weeks after treatment.

High-resolution nerve ultrasound (HRUS) and nerve conduction studies (NCS) were able to detect changes in nerve structure and function after 6 months, but corneal confocal microscopy (CCM) did not show early signs of TIPN, suggesting that clinical assessments remain the most effective method for early detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-resolution nerve ultrasound and corneal confocal microscopy in taxane-induced polyneuropathy. Katz, M., Mork, H., Baghdasaryan, N., et al.[2023]

Low-intensity pulsed low-frequency ultrasound treatment significantly improved symptoms of cisplatin-induced peripheral neuropathy in rats, enhancing pain perception and nerve conduction after 15 days of treatment.

The ultrasound therapy also reduced oxidative stress and inflammation, restored nerve structure, and regulated apoptosis, indicating its potential as an effective intervention for chemotherapy-related nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-intensity low-frequency pulsed ultrasound ameliorates sciatic nerve dysfunction in a rat model of cisplatin-induced peripheral neuropathy. Bilir-Yildiz, B., Sunay, FB., Yilmaz, HF., et al.[2022]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

The prevalence and pattern of chemotherapy-induced peripheral neuropathy among women with breast cancer receiving care in a large community oncology practice. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Predictive clinical factors of chronic peripheral neuropathy induced by oxaliplatin. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The role of neuromuscular ultrasound in diagnostics of peripheral neuropathies induced by cytostatic agents or immunotherapies. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Ultrasound assessment of oxaliplatin-induced neuropathy and correlations with neurophysiologic findings. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Neuromuscular ultrasound for taxane peripheral neuropathy in breast cancer. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Long-term Peripheral Sensory Neuropathy of 3 vs 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Colon Cancer: The ACHIEVE Phase 3 Randomized Clinical Trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Electroclinical biomarkers of early peripheral neurotoxicity from oxaliplatin. [2019]

8. England pubmed.ncbi.nlm.nih.gov

High-resolution nerve ultrasound and corneal confocal microscopy in taxane-induced polyneuropathy. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Low-intensity low-frequency pulsed ultrasound ameliorates sciatic nerve dysfunction in a rat model of cisplatin-induced peripheral neuropathy. [2022]