Is NCT07016971 recruiting in Hershey, PA?

Yes, NCT07016971 is currently recruiting participants at its Hershey, PA location. This chemotherapy-induced peripheral neuropathy clinical trial is actively enrolling qualified participants.

Is participation in this Hershey clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Chemotherapy-Induced Peripheral Neuropathy Clinical Trial in Hershey, PA

Q: How do I join the chemotherapy-induced peripheral neuropathy clinical trial in Hershey?

To join this clinical trial in Hershey, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Chemotherapy-Induced Peripheral Neuropathy Study in Hershey

The goal of this clinical trial is to learn if a commercially available cannabigerol (CBG)/cannabidiol (CBD) oil is safe, feasible to use, and can help reduce symptoms of chemotherapy-induced peripheral neuropathy (CIPN) in adults who have completed platinum-based chemotherapy for gastrointestinal cancers. The main questions it aims to answer are: Is CBG/CBD oil safe and well-tolerated over a 12-week treatment period? Can participants with CIPN use CBG/CBD oil consistently as part of their care? Does CBG/CBD oil help reduce pain, numbness, or other symptoms of CIPN? Participants will: Take CBG/CBD oil under the tongue (sublingually) twice daily for 12 weeks Complete regular symptom assessments and functional tests during study visits Provide blood samples for cannabinoid and metabolite level testing

Sponsor: Milton S. Hershey Medical Center

Who Can Participate

Inclusion Criteria

Adults aged 21 years or older.

Patients with grade 1 or greater CIPN symptoms, such as neuropathic pain, paresthesia, or muscle weakness, persisting for more than 2 weeks as defined by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 5.

Patients who have completed platinum-based chemotherapy for colorectal carcinoma, biliary tract carcinoma, pancreatic carcinoma, esophageal carcinoma, gastric carcinoma, or small intestinal carcinoma within the past 2 years.

Patients currently taking any treatment for CIPN must discontinue such treatments at least 2 weeks prior to enrollment.

Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (A pregnancy teste will be performed during screening (up to 28 days before treatment and repeated within 7 days prior to study drug initiation to confirm baseline status and minimize risk of unrecognized pregnancy).

Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 months after the last dose of protocol therapy. Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only).

Patients from Penn State Health.

Exclusion Criteria

Patients under the age of 21 years.

Patients with a history of preexisting neuropathy prior to chemotherapy.

Pregnant and nursing women.

Patients with hypertension that, in the investigator's judgement, is uncontrolled despite the use of anti-hypertensives, or with hypotension (systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<60 mmHg).

History of or active arterial thromboembolic event (e.g. stroke, myocardial infarction).

Patients who have used an investigational drug within 30 days prior to the screening visit or are currently participating in another interventional investigational study.

Patients who have liver function tests AST/ALT \> 3 times above the upper limits of normal (ULN) in the past year.

Patients who have suicidal ideation or uncontrolled depression within the past year.

Patients with known sensitivity to any components of CBG/CBD hemp extract.

Patients with known sensitivity to coconut oil.

Patients currently receiving active systemic anti-cancer therapies, including but not limited to chemotherapy, immunotherapy, targeted therapy (e.g., tyrosine kinase inhibitors, anti-HER2 therapy), or any other ongoing systemic treatment intended to control or reduce tumor burden.

Current use of moderate or strong inhibitors or inducers of CYP3A4 or CYP2C19.

Current use of sensitive CYP2C19 substrates with narrow therapeutic indices (e.g., diazepam, clobazam), unless the subject's primary physician agrees to adjust the dose and provide close therapeutic monitoring.

Current use of valproate or other medications known to significantly increase the risk of liver enzyme elevations when co-administered with cannabidiol.

Current use of medications that are primarily metabolized by CYP1A2 (e.g., theophylline) or CYP2B6 (e.g., bupropion, efavirenz) that cannot be safely monitored or dose-adjusted per the discretion of the study investigator. Occasional or dietary caffeine intake is permitted.

Current use of medications that are substrates of UGT1A9 (e.g., diflunisal, propofol, fenofibrate), UGT2B7 (e.g., gemfibrozil, lamotrigine, morphine, lorazepam), CYP2C8, or CYP2C9 (e.g., phenytoin) that cannot be safely monitored or dose-adjusted per the discretion of the study investigator.

Current use of other known hepatotoxic drugs unless the potential risk has been evaluated and deemed acceptable by the study investigator.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Hershey?

Yes, this clinical trial (NCT07016971) has an active research site in Hershey, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chemotherapy-Induced Peripheral Neuropathy Treatment Options in Hershey, PA

If you're searching for chemotherapy-induced peripheral neuropathy treatment options in Hershey, PA, this clinical trial (NCT07016971) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Hershey research site is actively enrolling participants for this clinical trial. You'll receive care from experienced chemotherapy-induced peripheral neuropathy specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chemotherapy-induced peripheral neuropathy clinical trials near you to find additional studies recruiting in your area.

Chemotherapy-Induced Peripheral Neuropathy Clinical Trial in Hershey, PA

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