Pilot Study of Hydroxychloroquine for the Treatment of AIMSS
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University
About this trial
The purpose of this study is to evaluate 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years at the time of informed consent
Ability to provide written informed consent and HIPAA authorization
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
Disqualifiers
Current or prior use of hydroxychloroquine or chloroquine within 6 months
Known hypersensitivity to hydroxychloroquine, chloroquine, or 4-aminoquinoline compounds
History of retinopathy or retinal vein occlusion issues Note: While there is an association between retinopathy and HCQ use, this occurs rarely and with long term use with higher cumulative doses that used here. Other clinical trials have not required retinal exam (example: CTO-TBCRC04627, approved by IU IRB)
History of congestive heart failure (any NYHA class)
Trial design
Design model
Single group
Treatments tested in this trial
Hydroxychloroquine Sulfate (HCQ)
DrugDrug: Hydroxychloroquine sulfate Dose: 400 mg orally once daily Duration: 12 weeks
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Hydroxychloroquine sulfateExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the efficacy of hydroxychloroquine
To evaluate the efficacy of hydroxychloroquine 400 mg daily in reducing joint pain associated with AIMSS as measured by change in Brief Pain Inventory (BPI) Average Pain score (scored from 0-10; a minimally important difference is a 2-point reduction or 30% from baseline).
Time frame
Day 1 and Week 12Secondary outcomes
1
Proportion of patients achieving a clinically meaningful improvement
To assess the proportion of patients achieving a clinically meaningful improvement (≥2-point reduction) in BPI Average Pain score.
Time frame
Day 1 and Week 122
Changes in BPI Worst Pain and Pain Interference scores
To evaluate changes in BPI Worst Pain and Pain Interference scores (scored from 0-10; a minimally important difference is a 2-point reduction or 30% from baseline).
Time frame
Day 1 and Week 123
Changes in endocrine therapy related quality of life
To assess changes in endocrine therapy related quality of life by FACT-ES (5 point Likert-type scale).
Time frame
Day 1 and Week 124
Changes in grip strength
To assess changes in grip strength as an objective measure of function using Jamar hand dynamometers (scale of 0-200lbs).
Time frame
Day 1 and Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
100 Voices of Hope
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: