20 Participants Needed

Ultrasound for Detecting Chemotherapy-Induced Peripheral Neuropathy

AF
Overseen ByAshley Fansler, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
Must be taking: Oxaliplatin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 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.12345

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.24567

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.34589

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.

Research Team

Roy E. Strowd III, MD, MEd, MS | Wake ...

Roy E. Strowd

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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.
See 2 more

Exclusion Criteria

I cannot provide my medical or treatment history.
I had nerve damage in my hands or feet before starting oxaliplatin chemotherapy.

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: UltrasoundExperimental Treatment6 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

Find a Clinic Near You

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+

Findings from Research

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.
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.
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.
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]

References

The prevalence and pattern of chemotherapy-induced peripheral neuropathy among women with breast cancer receiving care in a large community oncology practice. [2022]
Predictive clinical factors of chronic peripheral neuropathy induced by oxaliplatin. [2021]
The role of neuromuscular ultrasound in diagnostics of peripheral neuropathies induced by cytostatic agents or immunotherapies. [2023]
Ultrasound assessment of oxaliplatin-induced neuropathy and correlations with neurophysiologic findings. [2018]
Neuromuscular ultrasound for taxane peripheral neuropathy in breast cancer. [2021]
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]
Electroclinical biomarkers of early peripheral neurotoxicity from oxaliplatin. [2019]
High-resolution nerve ultrasound and corneal confocal microscopy in taxane-induced polyneuropathy. [2023]
Low-intensity low-frequency pulsed ultrasound ameliorates sciatic nerve dysfunction in a rat model of cisplatin-induced peripheral neuropathy. [2022]
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