Breast CancerPhase 2NCT05689359
Evaluation of Hydroxychloroquine to Prevent CIPN
A Phase 2 study testing Hydroxychloroquine in people with Breast Cancer and Gynecologic Cancer, run by University of Arizona.
Trial summary
The study is being done to research if hydroxychloroquine can prevent chemotherapy induced peripheral neuropathy. Certain chemotherapy drugs, like paclitaxel, are known to cause neuropathy which can impact quality of life. Currently, there are no options for preventing peripheral neuropathy. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer, Gynecologic Cancer, Early-stage Breast Cancer
- What is being tested?
- Hydroxychloroquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to 1 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stage 1-3 breast cancer or gynecological cancer treated with curative intent
- Age ≥ 21 years old
- No prior neurotoxic chemotherapies
- No other neurotoxic chemotherapies planned during paclitaxel treatment (i.e, platinum)
- Need to be treated with paclitaxel weekly x 12 doses as determined by their treating physician
- Be able to undergo MR Imaging
Show all 14Show fewer
- Be willing to comply with scheduled visits, treatment plan, and MR imaging
- Adequate organ function as defined as:
- Hematologic:
- Absolute neutrophil count (ANC) ≥ 1500/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 9 g/dL
- Hepatic:
- Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
- Renal:
- Estimated creatinine clearance (CrCl)≥ 50 mL/min by Cockcroft-Gault formula
Who cannot join
- Stage IV cancer
- CTCAE neurological function > grade 1 at baseline
- Mental limitation that precludes understanding of or completion of questionnaires
- History of diabetes or other neurological disorders
- Preexisting peripheral neuropathy
- Prior exposure to neurotoxic chemotherapy
Show all 13Show fewer
- Currently taking medication to treat or prevent neuropathy
- Have non-MRI compatible metallic objects on/in body
- Have metallic hardware in the lower extremity which is MR compatible however would create too much artifact for MR examination
- Pregnant or lactating patients. Women of childbearing potential and sexually active men must use an effective contraception method during rreatment and for three months after completing treatment. Patients of childbearing potential must have a negative serum or urine B-hCG pregnancy test at screening.
- History or current evidence of central serous retinopathy (CSR) or retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity) or macular degeneration.
- QTc prolongation defined as a QTcF > 500 ms
- Known glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
About this study
Official title: Phase 2, Single Center, Single Arm Study to Evaluate the Decrease in CIPN With the Addition of Hydroxychloroquine to Chemotherapy in Patients With Early Stage (1-3) Breast Cancer and Gynecological Cancers Treated With Curative Intent
The study is being done to research if hydroxychloroquine can prevent chemotherapy induced peripheral neuropathy. Certain chemotherapy drugs, like paclitaxel, are known to cause neuropathy which can impact quality of life. Currently, there are no options for preventing peripheral neuropathy. In addition, there are no useful methods to assess peripheral nerve damage. This study will also explore using a study MRI of patients' feet prior to starting chemotherapy and after they have completed chemotherapy to see if there is any difference in their nerve structure.
- Conditions
- Breast Cancer, Gynecologic Cancer, Early-stage Breast Cancer, Peripheral Neuropathy, Chemotherapy-induced Peripheral Neuropathy
- Being tested
- Hydroxychloroquine
- Keywords
- Chemotherapy Induced Peripheral Neuropathy, Hydroxycloroquine, Diffusion Tensor Imaging, Breast Cancer, Gynecologic Cancer, Paclitaxel, Neoadjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine will be administered at 600 mg po BID for 3 days prior to starting chemotherapy, continued during the course of chemotherapy, and for 7 days after chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Addition of Hydroxychloroquine to paclitaxel | Experimental | Hydroxychloroquine will be added to chemotherapy in patients with early stage (1-3) breast cancer and gynecological cancers. Receives: Drug: Hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic CIPN
The primary endpoint is symptomatic CIPN defined as increase in in FACT-GOG/Ntx-12 questionnaire score of greater than or equal to 3 points post-chemotherapy with hydroxychloroquine in combination with paclitaxel chemotherapy in patients with early-stage breast cancer or gynecologic malignancies.
Measured: Throughout study completion, an average of 6 months
Secondary outcomes (4)
Predicting Symptomatic CIPN: FA and ADC values derived from DTI
Baseline fractional anisotrophy (FA) and apparent diffusion coefficient (ADC) values derived from DTI will be used to predict symptomatic CIPN prior to starting and end of chemotherapy.
Measured: Baseline
Predicting Symptomatic CIPN: change in FA and ADC
Change in mean FA and ADC prior to starting and end of chemotherapy will be calculated. The mean of the change in FA and ADC values with 95% confidence intervals will be estimated (post- minus pre- chemotherapy). The baseline values and the change of FA and ADC will be used to predict the development of symptomatic CIPN using logistic regression.
Measured: Baseline and 12 weeks
Predicting Symptomatic CIPN: baseline NF-L levels
Baseline level of neurofilament light chain (NF-L) will be used to predict symptomatic CIPN. The baseline values will be used to predict development of symptomatic CIPN using logistic regression.
Measured: Baseline
Predicting Symptomatic CIPN: Changes in NF-L levels
Changes in NF-L levels with chemotherapy used to predict development of symptomatic CIPN. NF-L measures will be summarized across time and analyzed using linear mixed effects model.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study startJun 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Why it stopped: Per Principal Investigator, it is not feasible to move forward with this trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Segar, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689359
- Sponsor's protocol ID
- STUDY00001721
- Status last verified
- Mar 2024
- First submitted
- 9 Jan 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Single Center, Single Arm Study to Evaluate the Decrease in CIPN With the Addition of Hydroxychloroquine to Chemotherapy in Patients With Early Stage (1-3) Breast Cancer and Gynecological Cancers Treated With Curative Intent
- ClinicalTrials.gov ID
- NCT05689359
- Acronym / sponsor ID
- STUDY00001721
- Conditions
- Breast Cancer, Gynecologic Cancer, Early-stage Breast Cancer, Peripheral Neuropathy, Chemotherapy-induced Peripheral Neuropathy
- Keywords
- Chemotherapy Induced Peripheral Neuropathy, Hydroxycloroquine, Diffusion Tensor Imaging, Breast Cancer, Gynecologic Cancer, Paclitaxel, Neoadjuvant chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Per Principal Investigator, it is not feasible to move forward with this trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being done to research if hydroxychloroquine can prevent chemotherapy induced peripheral neuropathy. Certain chemotherapy drugs, like paclitaxel, are known to cause neuropathy which can impact quality of life. Currently, there are no options for preventing peripheral neuropathy. In addition, there are no useful methods to assess peripheral nerve damage. This study will also explore using a study MRI of patients' feet prior to starting chemotherapy and after they have completed chemotherapy to see if there is any difference in their nerve structure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Addition of Hydroxychloroquine to paclitaxel | Experimental | Drug: HydroxychloroquineHydroxychloroquine will be added to chemotherapy in patients with early stage (1-3) breast cancer and gynecological cancers. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients with stage 1-3 breast cancer or gynecological cancer treated with curative intent
- Age ≥ 21 years old
- No prior neurotoxic chemotherapies
- No other neurotoxic chemotherapies planned during paclitaxel treatment (i.e, platinum)
- Need to be treated with paclitaxel weekly x 12 doses as determined by their treating physician
Key exclusion criteria (13 listed)
- Stage IV cancer
- CTCAE neurological function > grade 1 at baseline
- Mental limitation that precludes understanding of or completion of questionnaires
- History of diabetes or other neurological disorders
- Preexisting peripheral neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineHydroxychloroquine will be administered at 600 mg po BID for 3 days prior to starting chemotherapy, continued during the course of chemotherapy, and for 7 days after chemotherapy. | Drug | Addition of Hydroxychloroquine to paclitaxel |
Primary outcome
Symptomatic CIPN
Time frame: Throughout study completion, an average of 6 months
The primary endpoint is symptomatic CIPN defined as increase in in FACT-GOG/Ntx-12 questionnaire score of greater than or equal to 3 points post-chemotherapy with hydroxychloroquine in combination with paclitaxel chemotherapy in patients with early-stage breast cancer or gynecologic malignancies.
4 secondary outcomes
Predicting Symptomatic CIPN: FA and ADC values derived from DTI
Time frame: Baseline
Predicting Symptomatic CIPN: change in FA and ADC
Time frame: Baseline and 12 weeks
Predicting Symptomatic CIPN: baseline NF-L levels
Time frame: Baseline
Predicting Symptomatic CIPN: Changes in NF-L levels
Time frame: Baseline and 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Segar, MD principal investigator
University of Arizona
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxychloroquine in people with Breast Cancer and Gynecologic Cancer, run by University of Arizona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic CIPN (time frame: Throughout study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.