Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer (PCC)
Primary Purpose
Pancreatic Cancer, Cholangiocarcinoma
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sildenafil
Sponsored by
About this trial
This is an interventional supportive care trial for Pancreatic Cancer focused on measuring cancer, pancreas, cholangiocarcinoma, fatigue, sildenafil, lean mass, muscle
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Use of cytochrome p450 inhibitors.
- 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).
- Peripheral vascular disease.
- Use of a phosphodiesterase 5 inhibitor.
- Any other circumstance deemed exclusionary by the PI or study physician.
Sites / Locations
- The University of Texas Medical Branch
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Sildenafil
Arm Description
Placebo daily for 4 weeks
50mg sildenafil daily for 4 weeks
Outcomes
Primary Outcome Measures
Lean Body Mass
Lean body mass will be measured by DEXA scan
Skeletal Muscle Fatigue
Skeletal muscle fatigue will be measured by leg dynamometer.
Secondary Outcome Measures
Full Information
NCT ID
NCT02106871
First Posted
January 30, 2014
Last Updated
October 25, 2017
Sponsor
The University of Texas Medical Branch, Galveston
1. Study Identification
Unique Protocol Identification Number
NCT02106871
Brief Title
Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer
Acronym
PCC
Official Title
Phase I Assessment of NO Mediated Signaling in Cancer Cachexia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study did not get funded. Study never started
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Cholangiocarcinoma
Keywords
cancer, pancreas, cholangiocarcinoma, fatigue, sildenafil, lean mass, muscle
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo daily for 4 weeks
Arm Title
Sildenafil
Arm Type
Active Comparator
Arm Description
50mg sildenafil daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Other Intervention Name(s)
Viagra
Intervention Description
50mg of Sildenafil daily for 4 weeks
Primary Outcome Measure Information:
Title
Lean Body Mass
Description
Lean body mass will be measured by DEXA scan
Time Frame
4 weeks
Title
Skeletal Muscle Fatigue
Description
Skeletal muscle fatigue will be measured by leg dynamometer.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Use of cytochrome p450 inhibitors.
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).
Peripheral vascular disease.
Use of a phosphodiesterase 5 inhibitor.
Any other circumstance deemed exclusionary by the PI or study physician.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melinda Sheffield-Moore, PhD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer
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