RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Hydroxychloroquine Sulfate (HCQ) for Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)

Q: Is NCT07825454 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT07825454?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT07825454?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

This study wants to measure the effectiveness of hydroxychloroquine sulfate (a type of drug commonly used to treat joint pain caused by inflammation, swelling) in reducing joint pain associated with Aromatase Inhibitor Associated Musculoskeletal Syndrome (AIMSS) for patients with breast cancer.

Official registry: https://clinicaltrials.gov/study/NCT07825454 · Indiana University · enrollment listed as 35

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Hydroxychloroquine Sulfate (HCQ). The registry lists allocation as na. This study wants to measure the effectiveness of hydroxychloroquine sulfate (a type of drug commonly used to treat joint pain caused by inflammation, swelling) in reducing joint pain associated with Aromatase Inhibitor Associated Musculoskeletal Syndrome (AIMSS) for patients with breast cancer.

They plan to enroll about 35 people at Indianapolis. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase II Single-Arm Pilot Study of Hydroxychloroquine for the Treatment of Aromatase Inhibitor-Associated Musculoskeletal Syndrome

Interventions: Hydroxychloroquine Sulfate (HCQ)

Primary outcome (registry wording): To evaluate the efficacy of hydroxychloroquine

Who it is for (from inclusion criteria)

Ages 18 Years to any
Diagnosis of DCIS or stage I, II, or III breast cancer
Currently receiving adjuvant aromatase inhibitor therapy (anastrozole, letrozole or exemestane) for ≥ 4 weeks prior to enrollment Note: Concurrent use of ovarian suppression is allowed Note: Concurrent use of CDK4/6 inhibitors is not allowed due to cytopenia risk
New or worsening self-reported musculoskeletal pain that began or significantly worsened after initiation of AI therapy
BPI average pain score of ≥ 4 during screening
Adequate organ function:
Absolute neutrophil count ≥1,500/µL
Hemoglobin ≥11.0 g/dL

Who the registry excludes

Current or prior use of hydroxychloroquine or chloroquine within 6 months
Known hypersensitivity to hydroxychloroquine, chloroquine, or 4-aminoquinoline compounds
History of congestive heart failure (any NYHA class)
QTc prolongation (\>450 msec) at screening or history of significant arrhythmias requiring treatment
Moderate to severe renal impairment (eGFR \<60 mL/min/1.73m2)
Use of a prohibited concomitant medication (refer to Section 6.3.2) that cannot be discontinued or changed to an alternate therapy
Known glucose-6-phosphate dehydrogenase (G6PD) deficiency

Public study contact (from the registry)

Niraj Shah, MS

317-278-3420

shahnir@iu.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana (recruiting)

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FAQ about this NCT record

Is NCT07825454 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07825454?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07825454?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary