Pancreatic CancerPhase 1PCCNCT02106871
Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer
A Phase 1 study testing Sildenafil in people with Pancreatic Cancer and Cholangiocarcinoma, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Investigation of the effects of daily sildenafil on patients with pancreatic or cholangiocarcinoma cancer undergoing treatment. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Pancreatic Cancer, Cholangiocarcinoma
- What is being tested?
- Sildenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatic Cancer, Cholangiocarcinoma
- Being tested
- Sildenafil
- Keywords
- cancer, pancreas, cholangiocarcinoma, fatigue, sildenafil, lean mass, muscle
- Medical subject headings
- Pancreatic Neoplasms, Cholangiocarcinoma, Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Also called Viagra
50mg of Sildenafil daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo daily for 4 weeks Receives: Drug: Sildenafil |
| Sildenafil | Active comparator | 50mg sildenafil daily for 4 weeks Receives: Drug: Sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean Body Mass
Lean body mass will be measured by DEXA scan
Measured: 4 weeks
Skeletal Muscle Fatigue
Skeletal muscle fatigue will be measured by leg dynamometer.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Why it stopped: Study did not get funded. Study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melinda Sheffield-Moore, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106871
- Sponsor's protocol ID
- 13-0409
- Acronym
- PCC
- Status last verified
- Oct 2017
- First submitted
- 30 Jan 2014
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Assessment of NO Mediated Signaling in Cancer Cachexia
- ClinicalTrials.gov ID
- NCT02106871
- Acronym / sponsor ID
- PCC / 13-0409
- Conditions
- Pancreatic Cancer, Cholangiocarcinoma
- Keywords
- cancer, pancreas, cholangiocarcinoma, fatigue, sildenafil, lean mass, muscle
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not get funded. Study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: SildenafilPlacebo daily for 4 weeks |
| Sildenafil | Active comparator | Drug: Sildenafil50mg sildenafil daily for 4 weeks |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women, aged 40-75 years.
- Diagnosed with Stage III or IV pancreatic or cholangiocarcinoma receiving the following therapy:
- Able to comprehend risks and sign a consent form.
- Performance Status of 0-2.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SildenafilAlso: Viagra50mg of Sildenafil daily for 4 weeks | Drug | Placebo, Sildenafil |
Primary outcome
Lean Body Mass
Time frame: 4 weeks
Lean body mass will be measured by DEXA scan
Skeletal Muscle Fatigue
Time frame: 4 weeks
Skeletal muscle fatigue will be measured by leg dynamometer.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melinda Sheffield-Moore, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sildenafil in people with Pancreatic Cancer and Cholangiocarcinoma, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lean Body Mass (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.