Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— PCC  

Official title:

Phase I Assessment of NO Mediated Signaling in Cancer Cachexia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02106871
• Other study ID #: 13-0409
• Status: Withdrawn
• Phase: Phase 1
• First received: January 30, 2014
• Last updated: October 25, 2017
• Start date: April 2014
• Est. completion date: June 2017

Study information

• Verified date: October 2017
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Sildenafil
50mg of Sildenafil daily for 4 weeks

Locations

Country	Name	City	State
United States	The University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lean Body Mass	Lean body mass will be measured by DEXA scan	4 weeks
Primary	Skeletal Muscle Fatigue	Skeletal muscle fatigue will be measured by leg dynamometer.	4 weeks