Brief Title
Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer
Official Title
Phase I Assessment of NO Mediated Signaling in Cancer Cachexia
Brief Summary
Investigation of the effects of daily sildenafil on patients with pancreatic or
cholangiocarcinoma cancer undergoing treatment.
Detailed Description
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Lean Body Mass
Condition
Pancreatic Cancer
Intervention
Sildenafil
Study Arms / Comparison Groups
Placebo
Description: Placebo daily for 4 weeks
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
April 2014
Completion Date
June 2017
Primary Completion Date
June 2017
Eligibility 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.
Gender
All
Ages
40 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Melinda Sheffield-Moore, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02106871
Organization ID
13-0409
Responsible Party
Sponsor
Study Sponsor
The University of Texas Medical Branch, Galveston
Study Sponsor
Melinda Sheffield-Moore, PhD, Principal Investigator, University of Texas
Verification Date
October 2017