Clinical trial · Interventional
Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer
Phase I Assessment of NO Mediated Signaling in Cancer Cachexia
NCT02106871CI-TRIAL-00030108PCCwithdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study did not get funded. Study never started
Summary
Brief summary (as posted)
Investigation of the effects of daily sildenafil on patients with pancreatic or cholangiocarcinoma cancer undergoing treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sildenafil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo daily for 4 weeks
- interventionNames
- Drug: Sildenafil
- type
- ACTIVE_COMPARATOR
- label
- Sildenafil
- description
- 50mg sildenafil daily for 4 weeks
- interventionNames
- Drug: Sildenafil
Primary outcomes (2)
- measure
- Lean Body Mass
- timeFrame
- 4 weeks
- description
- Lean body mass will be measured by DEXA scan
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.