Domperidone Access Program for Cancer Patients with Gastroparesis Who Haven't Responded to Standard Treatments

Sponsor: Eastern Regional Medical Center

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT02494687

Provider View

This program offers the medication Domperidone to cancer patients with gastroparesis, a condition where the stomach doesn't move food properly, who haven't found relief with standard treatments. The goal is to help improve digestion and relieve symptoms like nausea and chronic constipation.

Patient Parameters

Program Overview

Gastroparesis is a condition where the stomach's movement is slowed or stops, preventing normal digestion. This program provides Domperidone, a medication that helps the stomach move food, to patients who haven't responded to other treatments. It's offered under a special FDA program for patients with severe digestive issues, including gastroparesis, chronic constipation, and gastroesophageal reflux disease (GERD).

Description

Patients in this program will take Domperidone by mouth, starting with 10 mg four times a day for two weeks. If symptoms don't improve, the dose may be increased to 20 mg four times a day for another two weeks. If needed, the dose can be further increased to 30 mg four times a day. Patients will be evaluated regularly to see how well the treatment is working and to adjust the dose if necessary.

Eligibility Criteria

Inclusion Criteria

  • Male or female, aged 18 or older.
  • Have symptoms related to GERD, such as persistent heartburn or respiratory issues, or digestive problems like nausea, vomiting, severe indigestion, or chronic constipation that haven't improved with standard treatments.
  • Must undergo a thorough medical evaluation to rule out other causes of symptoms, which may include a physical exam and tests like an endoscopy or gastric emptying study.
  • Must sign a consent form acknowledging understanding of potential side effects, including increased prolactin levels, movement disorders, breast changes, and heart rhythm issues.

Exclusion Criteria

  • History of or current serious heart rhythm problems, such as ventricular tachycardia or fibrillation.
  • Significant slow heart rate or heart block, or prolonged QT interval on an ECG.
  • Significant electrolyte imbalances.
  • Gastrointestinal bleeding or blockage.
  • Presence of a prolactin-secreting pituitary tumor.
  • Pregnant or breastfeeding women.
  • Known allergy to Domperidone.

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