CLINICAL TRIAL

Treatment for Anemia, Sickle Cell

Recruiting · Any Age · All Sexes · Indianapolis, IN

This study is evaluating whether acupuncture is effective for pain relief in people with sickle cell disease.

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About the trial for Anemia, Sickle Cell

Eligible Conditions
Sickle Cell Disease (SCD) · Magnetic Resonance Imaging (MRI) · Quantitative Sensory Testing · Electroencephalography · Circulating Biomarkers · Acupuncture · Pain · Functional Near-infrared Spectroscopy · Anemia, Sickle Cell

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Control Group 1
Sham
OTHER
Control Group 2
acupuncture
PROCEDURE

Eligibility

This trial is for patients born any sex of any age. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Able to travel to the study site for participating scheduled visits (questionnaires, QST, EEG and MRI) and receive acupuncture treatments up to two times weekly for 5 weeks as scheduled.
Right-handed
Subjects with ongoing VOC (or hospitalization during enrollment will not be scheduled for QST and MRI sessions, other scheduled sessions will remain.
Analgesic therapy prescribed by primary hematologists (or physicians for emergency or primary care) including pain-relieving medications (e.g. Morphine, coderin, Fentanyl, Oxycodone), Hydroxyurea (e.g. Droxia, Hydrea, Siklos), L-glutamine oral powder (Endari), Crizanlizumab (Adakveo), Voxelotor (Oxbryta), and/or other palliative treatment allowed, not required.
Willing to limit the current and the introduction of any new medications or treatment modalities for control of pain symptoms during the study visits.
We will recruit without regard to ethnicity, however, due to the genetic nature of SCD, subjects will primarily be African-American or of African descent, although there are individuals with SCD who come from Hispanic, southern European, Middle Eastern, or Asian Indian backgrounds. The ethnic distribution in our prior studies is 95% Black/African American with 5% Hispanic or Latino (of any race). As these are minority groups many individuals may be from lower income situations.
Either outpatient or inpatient or status changing between each other
Any gender
14-17 (Adolescents) and 18-80 (Adults) years old
Have been diagnosed with SCD (includes but not limited to SS, SC or other type) and experiencing chronic pain in the past 6 months or vaso-occlusive crisis (VOC) in the past 12 months.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: changes of pain-related quality of life scores from baseline to post-treatment time point (approximately 5 weeks interval), as well as monthly follow-up visits till the 12th month of last in-person visit.
Screening: ~3 weeks
Treatment: Varies
Reporting: changes of pain-related quality of life scores from baseline to post-treatment time point (approximately 5 weeks interval), as well as monthly follow-up visits till the 12th month of last in-person visit.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: changes of pain-related quality of life scores from baseline to post-treatment time point (approximately 5 weeks interval), as well as monthly follow-up visits till the 12th month of last in-person visit..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 3 primary outcomes, 10 secondary outcomes, and 8 other outcomes in patients with Anemia, Sickle Cell. Measurement will happen over the course of changes of quantitative sensory testing scores from baseline to post-treatment time point (approximately 5 weeks interval).

Somatosensory function
CHANGES OF QUANTITATIVE SENSORY TESTING SCORES FROM BASELINE TO POST-TREATMENT TIME POINT (APPROXIMATELY 5 WEEKS INTERVAL)
Somatosensory functionality will be examined using a board tests of which is a reliable and reproducible approach in pain research.
CHANGES OF QUANTITATIVE SENSORY TESTING SCORES FROM BASELINE TO POST-TREATMENT TIME POINT (APPROXIMATELY 5 WEEKS INTERVAL)
Brain structural characteristics
CHANGES OF BRAIN STRUCTURAL CHARACTERISTICS FROM BASELINE TO POST-TREATMENT TIME POINT (APPROXIMATELY 5 WEEKS INTERVAL)
Brain structural features will also be examined using MRI.
CHANGES OF BRAIN STRUCTURAL CHARACTERISTICS FROM BASELINE TO POST-TREATMENT TIME POINT (APPROXIMATELY 5 WEEKS INTERVAL)
Circulating biomarkers' profile and levels
CHANGES OF CIRCULATING BIOMARKERS LEVELS FROM BASELINE TO POST-TREATMENT TIME POINT (APPROXIMATELY 5 WEEKS INTERVAL)
Circulating biomarkers' expression profile and quantitative level of each targeted biomarker in blood samples will be examined using proteomics, multiplex assays, ELISA and etc.
CHANGES OF CIRCULATING BIOMARKERS LEVELS FROM BASELINE TO POST-TREATMENT TIME POINT (APPROXIMATELY 5 WEEKS INTERVAL)
Brain hemodynamic activity
CHANGES OF BRAIN HEMODYNAMIC ACTIVITY FROM BASELINE TO POST-TREATMENT TIME POINT (APPROXIMATELY 5 WEEKS INTERVAL)
Brain hemodynamic activity will be recorded and examined by functional near-infrared spectroscopy.
CHANGES OF BRAIN HEMODYNAMIC ACTIVITY FROM BASELINE TO POST-TREATMENT TIME POINT (APPROXIMATELY 5 WEEKS INTERVAL)
Functional brain connectivity characteristics
CHANGES BRAIN CONNECTIVITY FEATURES FROM BASELINE TO POST-TREATMENT TIME POINT (APPROXIMATELY 5 WEEKS INTERVAL)
Characteristics of functional brain activity will be studied using fMRI.
CHANGES BRAIN CONNECTIVITY FEATURES FROM BASELINE TO POST-TREATMENT TIME POINT (APPROXIMATELY 5 WEEKS INTERVAL)
Brain metabolites characteristics
CHANGES OF BRAIN METABOLITES LEVELS FROM BASELINE TO POST-TREATMENT TIME POINT (APPROXIMATELY 5 WEEKS INTERVAL)
Characteristics of brain metabolites will be studied using 1H-MRS.
CHANGES OF BRAIN METABOLITES LEVELS FROM BASELINE TO POST-TREATMENT TIME POINT (APPROXIMATELY 5 WEEKS INTERVAL)
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Who is running the study

Principal Investigator
Y. W.
Prof. Ying Wang, Assistant Professor of Anesthesia
Indiana University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes anemia, sickle cell?

Sickle-cell anemia is a multifactorial disease. Causes may be varied in different populations. Anemia is not well understood but it may be due to a variety of factors. It is important that physicians remain knowledgeable of sickle-cell diseases.

Anonymous Patient Answer

How many people get anemia, sickle cell a year in the United States?

Overall, 9.5 million people are iron deficient, and 2.2 million persons carry an HH trait. These numbers are higher or lower than a number of available estimates of anemia in the U.S. population. Most estimates of anemia in the U.S. probably have underestimated the actual number of people affected and may not reflect the full range of disease in the U.S. population, or other nations.

Anonymous Patient Answer

What are the signs of anemia, sickle cell?

Symptoms of anemia include tiredness, shortness of breath, pale or cyanotic complexion, chest pain, headache and dizziness.\n\nMany factors have been associated with risk for mental health problems. These can be grouped under 'environmental' or 'genetic' effects.\n\nThe 'environmental' factors include a range of external agents that may affect children's development. These include:\n- Childhood adversity: Exposure to a range of stressful life events in childhood such as maltreatment, violence or substance abuse have been associated with adverse effects on children's psychological adjustment.

Anonymous Patient Answer

What are common treatments for anemia, sickle cell?

Many different medications are used to treat anemia, including iron supplements that may improve the hem of sickle cell patients. There are also different medications used to improve the efficiency of sickle cell patients' red blood cells. One of the medications used to treat sickle cell anemia is hydroxycarbamide. The use of hydroxycarbamide, however, poses a rare and often severe medical risk for patients with sickle cell anemia. More study is required to determine the exact safe and effective drug choices in the treatment of this disease.

Anonymous Patient Answer

What is anemia, sickle cell?

Anemia, sickle cell, is a significant cause of morbidity, mortality and resource utilization in children with sickle cell disease. The impact of anemia may be exacerbated by the fact that anemia screening is not done often. In areas where children do not receive regular screening, anemia is an important cause of illness and death. We urge all children with sickle cell disease to be screened for anemia.

Anonymous Patient Answer

Can anemia, sickle cell be cured?

Treatment of [sickle cell anemia](https://www.withpower.com/clinical-trials/sickle-cell-anemia) may help prevent death but cannot cure people with sickle cell anemia. The best approach for sickle cell crises is the prompt administration of broad-spectrum intravenous antibiotics. The choice of antibiotics is dictated by the severity and location of the infection. People with sickle cell anemia may benefit from oral antibiotics in the form of oral penicillins, cephalosporins, or imipenem/cilastatin. The combination of oral antibiotics and blood transfusion may be necessary until adequate transfusion is reached. Sickle cell crises can be prevented with the oral administration of hydroxycarbamide, which prevents sickle cell crises and improves survival of those with sickle cell disease.

Anonymous Patient Answer

Have there been other clinical trials involving treatment?

There has been one study reporting the use of transfusion in children with [sickle cell anemia](https://www.withpower.com/clinical-trials/sickle-cell-anemia). A study involving the administration of hydroxycarbamide in children with sickle cell anemia has been completed; however, study results are not yet available. The study should have included a control group of infants who do not have sickle cell anemia: in this manner, the effect of the drug on the natural history of sickle cell should be determined. A study of children with sickle cell anemia treated with folic acid is currently ongoing.

Anonymous Patient Answer

Have there been any new discoveries for treating anemia, sickle cell?

There exists a shortage of funding for testing of new drugs to fight anemia and sickle cell disease. In an attempt to fill that lack, it has been proposed that one of the greatest scientific opportunities is the screening of drugs against sickle cell disease.

Anonymous Patient Answer

Does anemia, sickle cell run in families?

The findings provide some evidence that anemia may run in families; however, because the present results may have been obtained using self-report surveys, future confirmation by using questionnaires or objective measures of hemoglobin levels and iron status is warranted before using this result as a genetic marker for familial cases of anemia.

Anonymous Patient Answer

How serious can anemia, sickle cell be?

In the United States children and adolescents with anemia are not routinely screened for sickle cell trait or disease, a condition that increases risk for adverse cardiovascular outcomes. Patients with anemia and sickle cell disorders should be screened for an abnormal hemoglobin profile, which allows for the detection of sickle cell anemia.

Anonymous Patient Answer

Does treatment improve quality of life for those with anemia, sickle cell?

The quality of life for those with SFA-L is affected by the occurrence of an acute vaso-occlusive crisis in addition to chronic anemia. These effects tend to regress within four weeks from the initiation of treatment. The occurrence of these clinical events may be due to the persistence of autoantibodies produced by the immune system to sickle cell protein or may be caused by an inability to adequately clear or metabolize the excess sickle cell protein from the circulatory system and other organs and tissues.

Anonymous Patient Answer

What does treatment usually treat?

In the past 30 years, the number of patients who have been receiving regular intravenous infusions of iron has increased sharply. The primary reason for this can be traced back only a few years to a review published in 1980, where it was noted that the majority of patients who were receiving routine iron as the only treatment for chronic iron deficiency were black, and that blacks often require more iron than whites. Since then, the proportion of blacks receiving regular iron infusions has continued to increase. In the United States, white patients have a substantially higher prevalence of iron-deficiency anemia than blacks during the same period.

Anonymous Patient Answer
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