LymphedemaPCTTPLNCT01893879
Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema
A study testing (RS)2-(3-benzoylphenyl)-propionic acid and laboratory biomarker analysis in people with Lymphedema and Unspecified Adult Solid Tumor, Protocol Specific, run by Stanford University at 1 site in United States.
Trial summary
This randomized clinical trial studies an investigational drug in preventing lymphedema in patients at high risk after undergoing axillary lymph node dissection. The study drug may prevent lymphedema in patients undergoing axillary lymph node dissection. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- (RS)2-(3-benzoylphenyl)-propionic acid and laboratory biomarker analysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Axillary lymph node dissection within the preceding 12 months
Who cannot join
- Patients with active cancer
- Patients with lymphedema
- Infection or bleeding tendency
- Patients with medical contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs), including history of allergies, know gastrointestinal intolerance
- Other serious systemic illness (e.g., renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would impair the patients' ability to participate
- Persons not competent to consent
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- Patients on aspirin therapy
- Minors (< 18 years of age)
- Pregnant and/or lactating women
- Males
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Hospitals and Clinics
Stanford, California, 94305
About this study
Official title: Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema in High Risk Patients
This randomized clinical trial studies an investigational drug in preventing lymphedema in patients at high risk after undergoing axillary lymph node dissection. The study drug may prevent lymphedema in patients undergoing axillary lymph node dissection.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy of study drug in improving chronic lymphedema while further elucidating the role of inflammatory and lymphangiogenic processes in the pathogenesis of this disease.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive study drug orally (PO) thrice daily (TID) for up to 1 year in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 5 years.
- Being tested
- placebo for study drug, (RS)2-(3-benzoylphenyl)-propionic acid, laboratory biomarker analysis
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo for study drugDrug
Also called PLCB
Given PO
(RS)2-(3-benzoylphenyl)-propionic acidDrug
Also called BPA
Given PO
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| (RS)2-(3-benzoylphenyl)-propionic acid | Experimental | Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis will be performed. Receives: Drug: (RS)2-(3-benzoylphenyl)-propionic acid; Other: laboratory biomarker analysis |
| placebo for study drug | Placebo comparator | Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.
Laboratory biomarker analysis will be performed. Receives: Drug: placebo for study drug; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Incidence of Lymphedema
Participants were evaluated every 3 months up to one year post lymph node dissection
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startApr 2014
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanley Rockson, Stanford University
- Investigators
- Stanley Rockson, Principal investigator, Stanford University Hospitals and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893879
- Sponsor's protocol ID
- IRB-20651
- Other IDs
- BRSNSTU0028, 4593
- Acronym
- PCTTPL
- Status last verified
- Apr 2017
- First submitted
- 2 Jul 2013
- Last updated
- 18 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema in High Risk Patients
- ClinicalTrials.gov ID
- NCT01893879
- Acronym / sponsor ID
- PCTTPL / IRB-20651
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient enrollment
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 9 Jul 2013 (estimated)
- Results
- Posted 18 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial studies an investigational drug in preventing lymphedema in patients at high risk after undergoing axillary lymph node dissection. The study drug may prevent lymphedema in patients undergoing axillary lymph node dissection.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy of study drug in improving chronic lymphedema while further elucidating the role of inflammatory and lymphangiogenic processes in the pathogenesis of this disease.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive study drug orally (PO) thrice daily (TID) for up to 1 year in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 5 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (RS)2-(3-benzoylphenyl)-propionic acid | Experimental | Drug: (RS)2-(3-benzoylphenyl)-propionic acid, Other: laboratory biomarker analysisPatients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity. Laboratory biomarker analysis will be performed. |
| placebo for study drug | Placebo comparator | Drug: placebo for study drug, Other: laboratory biomarker analysisPatients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity. Laboratory biomarker analysis will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Axillary lymph node dissection within the preceding 12 months
Key exclusion criteria (10 listed)
- Patients with active cancer
- Patients with lymphedema
- Infection or bleeding tendency
- Patients with medical contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs), including history of allergies, know gastrointestinal intolerance
- Other serious systemic illness (e.g., renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would impair the patients' ability to participate
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 |
|---|---|---|
| placebo for study drugAlso: PLCBGiven PO | Drug | placebo for study drug |
| (RS)2-(3-benzoylphenyl)-propionic acidAlso: BPAGiven PO | Drug | (RS)2-(3-benzoylphenyl)-propionic acid |
| laboratory biomarker analysisCorrelative studies | Other | (RS)2-(3-benzoylphenyl)-propionic acid, placebo for study drug |
Primary outcome
Number of Participants With Incidence of Lymphedema
Time frame: Up to 1 year
Participants were evaluated every 3 months up to one year post lymph node dissection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Stanley Rockson principal investigator
Stanford University Hospitals and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (RS)2-(3-benzoylphenyl)-propionic acid and laboratory biomarker analysis in people with Lymphedema and Unspecified Adult Solid Tumor, Protocol Specific, run by Stanford University 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 1 inclusion and 10 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: stopped early, as of the sponsor's last update on 18 May 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Incidence of Lymphedema (time frame: Up to 1 year). 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 18 May 2017.