Blood test may help cancer patients avoid nerve damage from chemo
NCT ID NCT03987555
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 4 times
Summary
This pilot study aims to see if doctors can consistently measure paclitaxel levels in the blood of cancer patients receiving the drug. The goal is to eventually adjust doses to give enough chemo to fight cancer while reducing the common side effect of nerve damage. The study involves 22 adults with various solid tumors and uses blood draws and surveys to track drug exposure and symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- paclitaxel
- What this could lead to
- If successful, this could help doctors adjust paclitaxel doses to reduce nerve damage while still effectively treating cancer.
- What could go wrong
- This is a small, early feasibility study with only 22 participants and is currently suspended. It focuses on whether blood monitoring is practical, not on proving it improves outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 55 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2019
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study is designed to enroll male and female patients with histologically-confirmed solid tumors who are anticipated to receive Paclitaxel as part of the curative or palliative antineoplastic therapy. The study will target lung, breast, and gynecologic (i.e. cervical, ovarian, uterine, and vulvar) cancers specifically.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female sex * Age ≥ 18 years at time of consent * Individuals receiving treatment at the Wake Forest Comprehensive Cancer Center who are anticipated to receive paclitaxel for curative or palliative intent, with or without surgery and/or radiation (i.e. neoadjuvant, adjuvant, or in the setting of recurrent or metastatic disease) as per decision with their medical oncologist for the following malignancies and dosing regimens: * Invasive breast cancer (any HER2 and ER/PR status) * Patients considered for curative or palliative chemotherapy with paclitaxel 80-175 mg/m2 with or without doxorubicin, cyclophosphamide, carboplatin, trastuzumab, bevacizumab, or pertuzumab Cervical cancer • Patients considered for curative or palliative chemotherapy with paclitaxel 135-175 mg/m2 with or without cisplatin, carboplatin, topotecan, or bevacizumab Non-small cell lung cancer • Patients considered for curative or palliative chemotherapy with paclitaxel 45-200 mg/m2 with or without carboplatin, cisplatin, bevacizumab, atezolizumab, or pembrolizumab Ovarian cancer • Patients considered for curative or palliative chemotherapy with paclitaxel 60-175 mg/m2 with or without carboplatin, cisplatin, ifosfamide, gemcitabine, pazopanib, or bevacizumab Uterine neoplasms • Patients considered for curative or palliative chemotherapy with paclitaxel 135-175 mg/m2 with or without carboplatin, cisplatin, doxorubicin, ifosfamide, bevacizumab, or trastuzumab Vulvar cancer (squamous cell carcinoma) * Patients considered for curative or palliative chemotherapy with paclitaxel 60-175 mg/m2 with or without cisplatin, carboplatin, or bevacizumab * Ability to understand and the willingness to sign an IRB-approved informed consent document * Patients with prior radiation treatment or surgery will not be disqualified from enrollment into the study, unless the aforementioned interventions resulted in peripheral neuropathy as a complication Exclusion Criteria: * Prior treatment with PTX, for any duration or indication * Prior treatment with neurotoxic chemotherapy including any taxane, vinca alkaloid, platinum-containing agent, bortezomib, or thalidomide that has resulted in clinical symptoms of persistent, CTCAE grade II or higher peripheral neuropathy * Concurrent enrollment in a clinical study of a neuroprotective intervention at the time of study initiation * Any contraindication to PTX (e.g. history of allergic reaction to paclitaxel or Kolliphor EL) * Current signs or symptoms of peripheral neuropathy at the time of enrollment, e.g. due to diabetes, HIV, or other conditions * Known personal or family history of hereditary peripheral neuropathy (e.g. Charcot-Marie-Tooth disease)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
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