Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer

NCT02106871 | Withdrawn Phase 1

• 1 other identifier: 13-0409
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer; Cholangiocarcinoma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Lean Body Mass

  Lean body mass will be measured by DEXA scan

  4 weeks

• Skeletal Muscle Fatigue

  Skeletal muscle fatigue will be measured by leg dynamometer.

  4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo daily for 4 weeks

Drug: Sildenafil

Sildenafil

ACTIVE COMPARATOR

50mg sildenafil daily for 4 weeks

Drug: Sildenafil

Interventions

Sildenafil DRUG

50mg of Sildenafil daily for 4 weeks

Also known as: Viagra

Placebo; Sildenafil

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, aged 40-75 years.
• Diagnosed with Stage III or IV pancreatic or cholangiocarcinoma receiving the following therapy:
• Neoadjuvant chemotherapy
• Surgical resection followed by chemotherapy.
• Able to comprehend risks and sign a consent form.
• Performance Status of 0-2.

You may not qualify if:

• Significant renal or heart disease or any acute metabolic disease.
• Evidence of hepatitis as indicated by a 3-fold increase in of 2 out of 3 liver enzymes.
• Diabetes mellitus or other untreated endocrine disease.
• Recent (within 3 months) treatment with anabolic steroids.
• Ongoing anticoagulant therapy.
• Androgen secreting tumors of the ovary and adrenal or any ovarian tumor (e.g., Sertoli-Leydig).
• Polycystic ovary syndrome (PCOS) and/or hyperthecosis.
• Non-classical adrenal hyperplasia.
• Cushing's syndrome.
• Glucocorticoid resistance.
• Pregnancy.
• Hyperprolactinoma, hypothyroidism.
• Use of nitrates.
• Use of alpha blockers.
• Use of protease inhibitors.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

The University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Cholangiocarcinoma; Neoplasms; Fatigue

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Melinda Sheffield-Moore, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: April 8, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

US (1)