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Keep this study
Lead
The University of Texas Medical Branch, Galveston
This is a double-blinded, placebo-controlled trial in men and women, 40-75 years old, diagnosed with pancreatic or cholangiocarcinoma cancer. Patients will receive placebo or sildenafil daily for 4 weeks during their initial chemotherapy cycle.
Age
40–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Men and women, aged 40-75 years.
2. Diagnosed with Stage III or IV pancreatic or cholangiocarcinoma receiving the following therapy:
* Neoadjuvant chemotherapy
* Surgical resection followed by chemotherapy.
3. Able to comprehend risks and sign a consent form.
4. Performance Status of 0-2.
You may not be if
1. Significant renal or heart disease or any acute metabolic disease.
2. Evidence of hepatitis as indicated by a 3-fold increase in of 2 out of 3 liver enzymes.
3. Diabetes mellitus or other untreated endocrine disease.
4. Recent (within 3 months) treatment with anabolic steroids.
5. Ongoing anticoagulant therapy.
6. Androgen secreting tumors of the ovary and adrenal or any ovarian tumor (e.g., Sertoli-Leydig).
17. 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).
18. Peripheral vascular disease.
19. Use of a phosphodiesterase 5 inhibitor.
20. Any other circumstance deemed exclusionary by the PI or study physician.
Clareo Health | Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer