Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer (PCC)

The University of Texas System (UT)

Status and phase: Withdrawn; Phase 1

Conditions: Cholangiocarcinoma; Pancreatic Cancer

Treatments: Drug: Sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT02106871

13-0409

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo daily for 4 weeks

Treatment:

Drug: Sildenafil

Sildenafil

Active Comparator group

Description:

50mg sildenafil daily for 4 weeks

Treatment:

Drug: Sildenafil