Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer

Phase I Assessment of NO Mediated Signaling in Cancer Cachexia

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02106871

Acronym

PCC

Enrollment

Registered

2014-04-08

Start date

2014-04-30

Completion date

2017-06-30

Last updated

2017-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma, Pancreatic Cancer

Keywords

cancer, pancreas, cholangiocarcinoma, fatigue, sildenafil, lean mass, muscle

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.

Interventions

DRUGSildenafil

50mg of Sildenafil daily for 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026