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Anti-malarial drug
Hydroxychloroquine for Preventing Peripheral Neuropathy
Phase 2
Waitlist Available
Led By Jennifer Segar, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with stage 1-3 breast cancer or gynecological cancer treated with curative intent
Need to be treated with paclitaxel weekly x 12 doses as determined by their treating physician
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study completion, an average of 6 months
Awards & highlights
Study Summary
This trial is researching if hydroxychloroquine can prevent chemotherapy-induced nerve damage, which affects quality of life. MRI scans will be used to assess nerve damage.
Who is the study for?
This trial is for adults over 21 with stage 1-3 breast or gynecological cancer, scheduled to receive paclitaxel chemotherapy. Participants must have good liver, blood, and kidney function and be able to undergo MRI scans. It's not for those who are pregnant, have metal implants that affect MRI, heart issues like QTc prolongation, preexisting neuropathy or diabetes, prior neurotoxic chemo treatments, or severe neurological impairments.Check my eligibility
What is being tested?
The study tests if hydroxychloroquine can prevent nerve damage (peripheral neuropathy) caused by the chemotherapy drug paclitaxel. Patients' feet will be scanned using MRI before and after treatment to detect any changes in nerve structure as a measure of potential prevention.See study design
What are the potential side effects?
Hydroxychloroquine may cause side effects such as stomach pain or cramps, nausea or vomiting, headache, dizziness; rare but serious side effects include vision problems and muscle weakness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have stage 1-3 breast or gynecological cancer treated with the goal of curing it.
Select...
My doctor has prescribed me 12 weekly doses of paclitaxel.
Select...
I am not planning to receive any other treatments that could harm my nerves during my paclitaxel treatment.
Select...
I have not had chemotherapy that affects the nervous system.
Select...
My kidneys work well enough (CrCl≥ 50 mL/min).
Select...
I am 21 years old or older.
Select...
My liver function tests are within normal limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout study completion, an average of 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study completion, an average of 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Symptomatic CIPN
Secondary outcome measures
Predicting Symptomatic CIPN: Changes in NF-L levels
Predicting Symptomatic CIPN: FA and ADC values derived from DTI
Predicting Symptomatic CIPN: baseline NF-L levels
+1 moreSide effects data
From 2016 Phase 3 trial • 217 Patients • NCT0205725013%
Upper respiratory tract infection
6%
Neutropenia
6%
Sinusitis
5%
Alanine aminotransferase increased
5%
Urinary tract infection
4%
Injection site erythema
4%
Accidental overdose
4%
Bronchitis
3%
Injection site pruritus
2%
Thrombocytopenia
2%
Nasopharyngitis
2%
Contusion
1%
Arthralgia
1%
Anaemia
1%
Lumbar spinal stenosis
1%
Leukopenia
1%
Coronary artery occlusion
1%
Wolff-Parkinson-White syndrome
1%
Transient ischaemic attack
1%
Vertebrobasilar insufficiency
1%
Chronic obstructive pulmonary disease
1%
Small intestinal obstruction
1%
Nephrolithiasis
1%
Cataract
1%
Thrombophlebitis superficial
1%
Vomiting
1%
Endometrial hyperplasia
1%
Traumatic arthritis
1%
Hypertension
1%
Pneumonia
1%
Pancreatic carcinoma metastatic
1%
Osteoarthritis
1%
Rheumatoid lung
1%
Pharyngitis
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sarilumab 150 mg by PFS (Extension Phase)
Sarilumab 150 mg by AID (AID Assessment Phase)
Sarilumab 150 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by AID (AID Assessment Phase)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Addition of Hydroxychloroquine to paclitaxelExperimental Treatment1 Intervention
Hydroxychloroquine will be added to chemotherapy in patients with early stage (1-3) breast cancer and gynecological cancers.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxychloroquine
2017
Completed Phase 4
~5360
Find a Location
Who is running the clinical trial?
University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,273 Total Patients Enrolled
Jennifer Segar, MDPrincipal InvestigatorUniversity of Arizona
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have stage 1-3 breast or gynecological cancer treated with the goal of curing it.My doctor has prescribed me 12 weekly doses of paclitaxel.I am not planning to receive any other treatments that could harm my nerves during my paclitaxel treatment.Your heart takes longer than usual to recharge between beats, measured as a QTcF greater than 500 milliseconds.I have or am at risk for serious eye conditions like CSR, RVO, or macular degeneration.I have not had chemotherapy that affects the nervous system.My kidneys work well enough (CrCl≥ 50 mL/min).I am not pregnant or breastfeeding and will use effective birth control during and for three months after treatment.You have metal objects inside or on your body that cannot be used during an MRI scan.I am 21 years old or older.I am unable to understand or fill out questionnaires due to mental limitations.I have been treated with chemotherapy that can affect the nerves.My organs are functioning well.I have nerve damage in my hands or feet.My liver function tests are within normal limits.I have a G-6-PD deficiency.Your blood counts should be within certain ranges: a neutrophil count of at least 1500, a platelet count of at least 100,000, and a hemoglobin level of at least 9.I am on medication for neuropathy.I have diabetes or a neurological disorder.My cancer is at stage IV.You have neurological issues greater than mild at the start of the study.You have metal in your leg that would make it difficult to take pictures with a special machine called MRI.
Research Study Groups:
This trial has the following groups:- Group 1: Addition of Hydroxychloroquine to paclitaxel
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the administration of hydroxychloroquine alongside paclitaxel received regulatory approval?
"Our assessment of the safety profile for combining hydroxychloroquine and paclitaxel was a 2. This is because, as this clinical trial is on Phase 2, there has been limited efficacy data but some evidence supporting its safety."
Answered by AI
Are there still opportunities available for participants in this research project?
"According to information hosted on clinicaltrials.gov, the enrolment of participants for this medical trial has ceased; it was initially posted on February 1st 2023 and last updated January 9th 2023. However, there are more than 2700 other studies that are currently in search of volunteers."
Answered by AI
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