Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer

Study Overview
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Brief Summary
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Investigation of the effects of daily sildenafil on patients with pancreatic or cholangiocarcinoma cancer undergoing treatment.

Detailed Description
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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.

Official Title
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Phase I Assessment of NO Mediated Signaling in Cancer Cachexia

Conditions
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Pancreatic Cancer, Cholangiocarcinoma

Intervention / Treatment
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* Drug: Sildenafil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo daily for 4 weeks | Drug: Sildenafil<br>* 50mg of Sildenafil daily for 4 weeks<br>* Other names: Viagra;|
| Active Comparator: Sildenafil<br>50mg sildenafil daily for 4 weeks | Drug: Sildenafil<br>* 50mg of Sildenafil daily for 4 weeks<br>* Other names: Viagra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean Body Mass | Lean body mass will be measured by DEXA scan | 4 weeks | 
| Skeletal Muscle Fatigue | Skeletal muscle fatigue will be measured by leg dynamometer. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, sildenafil, lean mass, muscle, cancer, pancreas, cholangiocarcinoma