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

October 25, 2017 updated by: The University of Texas Medical Branch, Galveston

Phase I Assessment of NO Mediated Signaling in Cancer Cachexia

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

Study Overview

Status

Withdrawn

Conditions

Intervention / 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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77555
        • The University of Texas Medical Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo daily for 4 weeks
Drug: Sildenafil
50mg of Sildenafil daily for 4 weeks
Other Names:
  • Viagra
Active Comparator: Sildenafil
50mg sildenafil daily for 4 weeks
Drug: Sildenafil
50mg of Sildenafil daily for 4 weeks
Other Names:
  • Viagra

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Investigators

  • Principal Investigator: Melinda Sheffield-Moore, PhD, University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

January 30, 2014

First Submitted That Met QC Criteria

April 3, 2014

First Posted (Estimate)

April 8, 2014

Study Record Updates

Last Update Posted (Actual)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-0409

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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