Liver Cirrhosis, Muscle Cramps
Conditions
Keywords
liver cirrhosis, muscle cramps
Brief summary
This is a pilot study to see if hydroxychloroquine (HCQ) if safe and effective to use with patients having cramps due to their cirrhotic liver disease.
Detailed description
This project is proposed as a pilot study to gather preliminary data for a full-scale randomized trial to assess the efficacy and safety of hydroxychloroquine (HCQ) in the treatment of muscle cramps in patients with cirrhosis.
Interventions
DRUGHydroxychloroquine
daily dosing
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* previous diagnosis of cirrhosis * adult (\>21 years) * able to complete a written questionnaire in English * stable and ambulatory * MELD score \< 25, Platelet count \>25,000
Exclusion criteria
* people allergic to hydroxychloroquine, 4-aminoquinolone derivatives or any component of the formulation * previous diagnosis of retinal or visual field changes attributable to 4-aminoquinolone * previous diagnosis of porphyria * previous diagnosis of psoriasis * fulminant hepatic failure * pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| frequency and severity of muscle cramps in cirrhotic patients reporting the symptom, based on the modified muscle cramps questionnaire (mMCQ) | 1 month after completion of questionnaire | Patients will be given the mMCQ and SF-12 to complete. These instruments will be scored according to established algorithms. Data analysis will include descriptive statistics (frequency, duration and severity of muscle cramps) and correlation between overall quality of life and the mMCQ summary score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety and efficacy of HCQ for severe cramping using mMCQ, SF-12, and AE inventory. | 28 days after first dose | The study intervention will include open label HCQ daily, which will be provided for the patients for two weeks. A designated coordinator will contact the patient 2 and 7 days of the study to ask of adverse events and fill out the AE inventory. At the end of the dosing, patients will be asked to return to the clinic for post-intervention assessment, which will include the mMCQ, SF-12, systemic AE inventory, CBC and EKG. Designated coordinator will contact patient again on day 28 of the study to ask mMCQ, SF-12, AE inventory. |
Countries
United States
Outcome results
None listed