Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer

Phase 1

Withdrawn

• Conditions: Pancreatic Cancer; Cholangiocarcinoma
• Interventions: Drug: Sildenafil

• Registration Number: NCT02106871
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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 Timeline

• Study First Submitted: 2014-01-30
• Study Start: 2014-04
• Study First Submitted QC: 2014-04-03
• Study First Posted: 2014-04-08
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Sildenafil	Placebo daily for 4 weeks
Sildenafil	Sildenafil	50mg sildenafil daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Lean Body Mass	4 weeks	Lean body mass will be measured by DEXA scan
Skeletal Muscle Fatigue	4 weeks	Skeletal muscle fatigue will be measured by leg dynamometer.

Trial Locations

Locations (1)

The University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States