ArthralgiaNCT01096407
Role of Biomarkers in Muscle Pain and Joint Pain in Patients With Solid Tumors Receiving Paclitaxel
An observational study of Arthralgia and Pain, run by Vanderbilt-Ingram Cancer Center at 2 sites in United States.
Trial summary
RATIONALE: Learning about pain in patients with cancer receiving paclitaxel may help plan treatment and may help patients live more comfortably. Studying samples of urine from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to muscle and joint pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthralgia, Pain, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- laboratory biomarker analysis, questionnaire administration and assessment of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2009to Nov 2010
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients that will be treated with paclitaxel.
DISEASE CHARACTERISTICS:
- Solid malignancy of any type
- Patients must be scheduled to receive their first dose of paclitaxel at Vanderbilt-Ingram Cancer Center
- Any paclitaxel-containing regimen or dosing schedule is allowed
PATIENT CHARACTERISTICS:
- Not pregnant
- Accessible for follow-up
- Able to submit urine samples
- Able to complete questionnaires
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: The Role of COX-2 Mediated Prostaglandin Production on Paclitaxel-Induced Myalgias and Arthralgias.
RATIONALE: Learning about pain in patients with cancer receiving paclitaxel may help plan treatment and may help patients live more comfortably. Studying samples of urine from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to muscle and joint pain.
PURPOSE: This phase I trial is studying the role of biomarkers in muscle pain and joint pain in patients with solid tumors receiving paclitaxel.
Read the detailed description
OBJECTIVES:
Primary
- To determine the change in urinary prostaglandin E metabolite (PGE-M) level after paclitaxel treatment in patients with a variety of solid tumor malignancies.
- To determine whether a change in PGE-M level correlates with paclitaxel dose.
- To determine whether the change in urinary PGE-M level correlates with patient reporting of pain, as measured by a visual analog scale and the Brief Pain Inventory short form (BPI-SF).
Secondary
- To determine whether leukotriene levels are affected by paclitaxel treatment.
OUTLINE: At baseline (prior to the first dose of paclitaxel), patients complete a questionnaire about their baseline pain symptoms (including the Brief Pain Inventory short form and the visual analog scale); cigarette smoking status and second-hand smoke exposure; and routine use of any pain medications (including NSAIDs, selective COX-2 inhibitors, and opioid analgesics), corticosteroids, or leukotriene antagonists (montelukast or zafirlukast). Patients also complete questionnaires about their pain daily on days 2-7 after paclitaxel administration.
Urine samples are collected at baseline for urinary prostaglandin E metabolite (PGE-M), urinary leukotriene E_4 (LTE_4), and urinary cotinine levels and on day 4 for urinary PGE-M and LTE_4 levels.
- Being tested
- laboratory biomarker analysis, questionnaire administration, assessment of therapy complications
- Keywords
- pain, arthralgia, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Arthralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Collection of urine samples
questionnaire administrationOther
Completion of questionnaires
assessment of therapy complicationsProcedure or surgery
An assessment will be completed.
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel-Induced Myalgias/Arthralgias | Not described Receives: Other: laboratory biomarker analysis; Other: questionnaire administration; Procedure: assessment of therapy complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urinary PGE-M level after paclitaxel treatment
Change in amount of PGE-M in the urine from before administration of paclitaxel to 4 days after treatment.
Measured: Day 1 before paclitaxel treatment and day 4, after treatment
Secondary outcomes (3)
Correlation of change in urinary PEG-M level and paclitaxel dose
Inter-relationship between the dose of paclitaxel and the change in level of urinary PEG-M from before treatment compared to day 4 of paclitxel treatment
Measured: Day 1 before paclitaxel treatment and day 4, after treatment
Correlation of urinary PEG-M level with pain
Inter-relationship between the level of urinary PEG-M level with level of pain, measured from before treatment compared to day 4 after paclitaxel treatment. Pain is measured on the Brief Pain Inventory (BPI). The BPI consists of 7 questions about interference of pain in daily life, answered on a scale of 0 (does not interfere) to 10 (completely interferes). The summary score is the average of the 7 scores, with higher scores indicating greater interference with pain.
Measured: day 1 before paclitaxel treatment and day 4, after treatment
Change in urinary luekotriene E_4 level after paclitaxel treatment
Inter-relationship be the level of urinary luekotriene E_4 from before treatment compared to day 4 after paclitaxel treatment
Measured: day 1 before paclitaxel treatment and day 4, after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startNov 2009
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthralgiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jill Gilbert, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Jill Gilbert, M.D., Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096407
- Sponsor's protocol ID
- VICC SUPP 0928
- Other IDs
- P30CA068485, VU-VICC-SUPP-0928
- Status last verified
- Mar 2013
- First submitted
- 30 Mar 2010
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of COX-2 Mediated Prostaglandin Production on Paclitaxel-Induced Myalgias and Arthralgias.
- ClinicalTrials.gov ID
- NCT01096407
- Acronym / sponsor ID
- VICC SUPP 0928
- Keywords
- pain, arthralgia, unspecified adult solid tumor, protocol specific
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 31 Mar 2010 (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.
RATIONALE: Learning about pain in patients with cancer receiving paclitaxel may help plan treatment and may help patients live more comfortably. Studying samples of urine from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to muscle and joint pain.
PURPOSE: This phase I trial is studying the role of biomarkers in muscle pain and joint pain in patients with solid tumors receiving paclitaxel.
Detailed description
OBJECTIVES:
Primary
- To determine the change in urinary prostaglandin E metabolite (PGE-M) level after paclitaxel treatment in patients with a variety of solid tumor malignancies.
- To determine whether a change in PGE-M level correlates with paclitaxel dose.
- To determine whether the change in urinary PGE-M level correlates with patient reporting of pain, as measured by a visual analog scale and the Brief Pain Inventory short form (BPI-SF).
Secondary
- To determine whether leukotriene levels are affected by paclitaxel treatment.
OUTLINE: At baseline (prior to the first dose of paclitaxel), patients complete a questionnaire about their baseline pain symptoms (including the Brief Pain Inventory short form and the visual analog scale); cigarette smoking status and second-hand smoke exposure; and routine use of any pain medications (including NSAIDs, selective COX-2 inhibitors, and opioid analgesics), corticosteroids, or leukotriene antagonists (montelukast or zafirlukast). Patients also complete questionnaires about their pain daily on days 2-7 after paclitaxel administration.
Urine samples are collected at baseline for urinary prostaglandin E metabolite (PGE-M), urinary leukotriene E_4 (LTE_4), and urinary cotinine levels and on day 4 for urinary PGE-M and LTE_4 levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel-Induced Myalgias/Arthralgias | – | Other: laboratory biomarker analysis, Other: questionnaire administration, Procedure: assessment of therapy complications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients that will be treated with paclitaxel.
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 |
|---|---|---|
| laboratory biomarker analysisCollection of urine samples | Other | Paclitaxel-Induced Myalgias/Arthralgias |
| questionnaire administrationCompletion of questionnaires | Other | Paclitaxel-Induced Myalgias/Arthralgias |
| assessment of therapy complicationsAn assessment will be completed. | Procedure or surgery | Paclitaxel-Induced Myalgias/Arthralgias |
Primary outcome
Change in urinary PGE-M level after paclitaxel treatment
Time frame: Day 1 before paclitaxel treatment and day 4, after treatment
Change in amount of PGE-M in the urine from before administration of paclitaxel to 4 days after treatment.
3 secondary outcomes
Correlation of change in urinary PEG-M level and paclitaxel dose
Time frame: Day 1 before paclitaxel treatment and day 4, after treatment
Correlation of urinary PEG-M level with pain
Time frame: day 1 before paclitaxel treatment and day 4, after treatment
Change in urinary luekotriene E_4 level after paclitaxel treatment
Time frame: day 1 before paclitaxel treatment and day 4, after treatment
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
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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.
Jill Gilbert, M.D. principal investigator
Vanderbilt-Ingram Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthralgia and Pain, run by Vanderbilt-Ingram Cancer Center at 2 sites 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?
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 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
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?
Change in urinary PGE-M level after paclitaxel treatment (time frame: Day 1 before paclitaxel treatment and day 4, after treatment). 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 4 Apr 2013.