Peripheral Neuropathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Healthy volunteers (Part I):

• White males between 18 and 45 years old
• People who have not smoked for at least 6 months before the study begins
• People with a body mass index (a measure of body weight relative to height) between 18 and 30
• People who are in good general health based on a medical check-up and vital signs
• People who understand what the study involves and are willing to give written consent to take part
• People whose sex, age, and body mass index match those of the patient group (this applies to Part II only)

Patients with nerve damage from chemotherapy (Part II):

• White males or females between 18 and 70 years old
• People who have not smoked for at least 6 months before the study begins
• People with a body mass index between 18 and 35
• People who have previously been treated with either paclitaxel or oxaliplatin (both are chemotherapy medicines)
• People who have mild to moderate nerve damage (grades 1, 2, or 3) based on a standard nerve assessment tool called the Total Neuropathy Score
• People who have nerve-related symptoms (such as tingling, numbness, or pain) in the arms or hands
• People whose chemotherapy treatment ended more than 1 month ago but less than 1 year ago
• People who understand what the study involves and are willing to give written consent to take part

Patients about to start chemotherapy (Part III):

• White males or females between 18 and 75 years old
• People who have not smoked for at least 6 months before the study begins
• People with a body mass index between 18 and 35
• People who are scheduled to receive paclitaxel or oxaliplatin chemotherapy in the near future
• People who understand what the study involves and are willing to give written consent to take part

Who may not be able to join:

• People who have skin conditions such as eczema, psoriasis, scleroderma, dermatitis, keloids, ulcers, burns, skin grafts, or tumours on their fingers, or any other finger skin abnormality that the study doctor believes could affect the assessments
• People with excessive hair growth on their fingers
• People who are unable to avoid heavy sun exposure or tanning beds (enough to cause sunburn) throughout the study
• People who have a history of serious or severe allergies, including drug allergies
• People who regularly use prescription or non-prescription medicines that the study doctor believes could affect the results
• People who regularly use lotions, oils, hair removal products, makeup, or other products on their fingers and are unable to stop using them for the duration of the study
• People who are unable to avoid alcohol for 24 hours before each study visit, who currently use illegal drugs, or who have a history of drug or alcohol misuse
• People who are unable to avoid caffeinated drinks (such as coffee, tea, or cola) for 24 hours before each study visit, or who drink more than 4 caffeinated drinks per day
• People whose heart rate, or blood pressure readings are outside the normal ranges set by the study at the screening check-up (confirm with trial site for exact values)
• People who are currently taking part in, or have taken part in, another clinical trial involving an experimental medicine within the last 4 weeks
• People who have any condition or situation that, in the study doctor's opinion, could affect safe participation
• People who have a history of any illness or condition that, in the study doctor's opinion, could affect the study results
• People (patients only) who had nerve damage before starting chemotherapy
• People in Parts II and III who have, or have had, diabetes, a vitamin B deficiency, amyloidosis, or any other condition the study doctor believes may cause nerve damage
• People in Parts II and III who have, or have had, a nervous system injury or condition that could cause nerve pain, such as spinal cord injury, multiple sclerosis, or certain brain or spinal cord disorders (confirm with trial site for full list)
• People in Parts II and III who have previously been treated with bortezomib, vincristine, or any other medicine that the study doctor believes may cause nerve pain
• People in the paclitaxel group in Part III who did not develop nerve damage after a previous treatment with epirubicin-cyclophosphamide
• People in Parts II and III who have a family history of peripheral neuropathy (nerve damage affecting the hands and feet)

Important: Always verify eligibility with the trial site directly before applying.