Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer
Conditions
Pancreatic Cancer - Cholangiocarcinoma
Conditions: official terms
Cholangiocarcinoma - Pancreatic Neoplasms
Conditions: Keywords
cancer, pancreas, cholangiocarcinoma, fatigue, sildenafil, lean mass, muscle
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Intervention
Name: Sildenafil
Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 40 Years
Gender: Both
Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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).

7. Polycystic ovary syndrome (PCOS) and/or hyperthecosis.

8. Non-classical adrenal hyperplasia.

9. Cushing's syndrome.

10. Glucocorticoid resistance.

11. Pregnancy.

12. Hyperprolactinoma, hypothyroidism.

13. Use of nitrates.

14. Use of alpha blockers.

15. Use of protease inhibitors.

16. Use of cytochrome p450 inhibitors.

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.
Location
The University of Texas Medical Branch
Galveston, Texas, United States
Status: Recruiting
Contact: Kate Randolph, BS - 409-772-8126 - kmrandol@utmb.edu
Start Date
April 2014
Sponsors
The University of Texas Medical Branch, Galveston
Source
The University of Texas Medical Branch, Galveston
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page