Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer
Withdrawn before enrolling · Phase 1 · Has a placebo group
Conditions studied: Pancreatic Cancer, Cholangiocarcinoma
In brief
Investigation of the effects of daily sildenafil on patients with pancreatic or cholangiocarcinoma cancer undergoing treatment.
Key facts
- Study ID
- NCT02106871
- Run by
- The University of Texas Medical Branch, Galveston
- People needed
- 0
- Starts
- 2014-04-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2017-10-27
Who can join
Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men and women, aged 40-75 years.
- Diagnosed with Stage III or IV pancreatic or cholangiocarcinoma receiving the following therapy:
- Neoadjuvant chemotherapy
- Surgical resection followed by chemotherapy.
- Able to comprehend risks and sign a consent form.
- Performance Status of 0-2.
You may not qualify if…
- Significant renal or heart disease or any acute metabolic disease.
- Evidence of hepatitis as indicated by a 3-fold increase in of 2 out of 3 liver enzymes.
- Diabetes mellitus or other untreated endocrine disease.
- Recent (within 3 months) treatment with anabolic steroids.
- Ongoing anticoagulant therapy.
- Androgen secreting tumors of the ovary and adrenal or any ovarian tumor (e.g., Sertoli-Leydig).
- Polycystic ovary syndrome (PCOS) and/or hyperthecosis.
- Non-classical adrenal hyperplasia.
- Cushing's syndrome.
- Glucocorticoid resistance.
- Pregnancy.
- Hyperprolactinoma, hypothyroidism.
- Use of nitrates.
- Use of alpha blockers.
- Use of protease inhibitors.
- Use of cytochrome p450 inhibitors.
- Systolic blood pressure <100 or >150, diastolic blood pressure <60 or >90. This range is smaller than the acceptable range stated in the prescribing information for sildenafil (>90/50 and <170/110).
- Peripheral vascular disease.
- Use of a phosphodiesterase 5 inhibitor.
- Any other circumstance deemed exclusionary by the PI or study physician.
Where it is running
- The University of Texas Medical Branch — Galveston, Texas, United States
Full record on ClinicalTrials.gov
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