Pegfilgrastim-induced Back and Leg PainPhase 2NCT01311336
Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain
A Phase 2 study testing Loratadine in people with Pegfilgrastim-induced Back and Leg Pain, run by University of Vermont at 7 sites in United States.
Trial summary
The purpose of this study is to determine the incidence of pegfilgrastim-induced back and leg pain and to determine whether the antihistamine loratadine can prevent pegfilgrastim-induced back and leg pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pegfilgrastim-induced Back and Leg Pain
- What is being tested?
- Loratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2011to Jun 2013
- Phase
- Phase 2
- 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
Who may be able to join
- histologic or cytologic evidence of malignancy
- scheduled to receive pegfilgrastim with two consecutive cycles of similar chemotherapy with at least a 14 day interval between cycles
- adequate renal function: estimated creatinine clearance > 30 ml/min
- adequate hepatic function: AST, ALT, total bilirubin <= 2.5 x ULN
- age >= 18 years
- performance status 0-3
- able to read and understand English
- signed Informed Consent
Who cannot join
- history of hypersensitivity or intolerance to antihistamines
- concurrent use of antihistamines other than study medications during or for 2 days prior to the study period except for a single dose of antihistamine as required for administration of chemotherapy or blood transfusion
- concomitant use of amiodarone
- previous use of pegfilgrastim or filgrastim
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Mountainview Medical Center
Berlin Corners, Vermont, 05602
John Valentine, MD, 802-225-5400, john.valentine@cvmc.org
John Valentine, MD
- Recruiting
Cancer Care of Maine
Brewer, Maine, 04412
Thomas H Openshaw, MD, 207-973-7478, topenshaw@emh.org
Thomas H Openshaw, MD
- Recruiting
Vermont Cancer Center
Burlington, Vermont, 05405
Steven M Grunberg, MD, 802-656-5457, steven.grunberg@uvm.edu
Karen M Wilson, MEd, 802-656-4101, karen.m.wilson@uvm.edu
- Recruiting
Vermont Center for Cancer Medicine
Colchester, Vermont, 05446
Dennis Sanders, MD, 802-655-3400, Dennis.Sanders@vtmednet.org
Paul Unger, MD
- Recruiting
CR Wood Cancer Center
Glens Falls, New York, 12801
Aqeel Gillani, MD, 518-926-6700, aqeelgillani@hotmail.com
Aqeel Gillani, MD
- Recruiting
Maine Center for Cancer Medicine
Scarborough, Maine, 04074
Matthew Dugan, DO, 207-885-7600, duganm@mccm.org
Matthew Dugan, DO
- Recruiting
York Hospital
York Village, Maine, 03909
Jonathan Eneman, MD, 207-351-3777, jeneman@yorkhospital.com
Jonathan Eneman, MD
About this study
Official title: Randomized Phase II Pilot Study of Loratadine for the Prevention of Pain Caused by the Granulocyte Colony Stimulating Factor Pegfilgrastim
The purpose of this study is to determine the incidence of pegfilgrastim-induced back and leg pain and to determine whether the antihistamine loratadine can prevent pegfilgrastim-induced back and leg pain.
Read the detailed description
Pegfilgrastim is a myeloid growth factor that stimulates neutrophil precursors and can be used to decrease infection risk associated with neutropenia. However pegfilgrastim may induce back and leg pain in 20-50% of patients. No intervention has been consistently successful in treating or preventing this pain.
The exact mechanism of pegfilgrastim-induced pain is unknown but may be related to histamine-mediated inflammation. Several case reports and anecdotal reports have suggested efficacy of antihistamines for this indication.
This study will have two parts. In the first part (Observational Phase), patients receiving pegfilgrastim will be surveyed to document the incidence of significant pegfilgrastim-induced back and leg pain. In the second part (Treatment Phase), patients who previously experienced such pain will be randomized to receive a 7-day course of either the antihistamine loratadine or placebo to determine whether pegfilgrastim-induced back and leg pain can be prevented with this intervention.
- Conditions
- Pegfilgrastim-induced Back and Leg Pain
- Being tested
- Loratadine, placebo
- Keywords
- Pegfilgrastim, Loratadine, Myalgia/arthralgia
- Medical subject headings
- Myalgia, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoratadineDrug
Also called Claritin
loratadine 10 mg capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim
placeboDrug
placebo capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim
| Study group | Role | What they receive |
|---|---|---|
| Loratadine | Active comparator | Loratadine 10 mg once a day for 7 days beginning the day of pegfilgrastim treatment in patients with pegfilgrastim-induced back and leg pain during the previous treatment cycle Receives: Drug: Loratadine |
| Placebo | Placebo comparator | Placebo once a day for 7 days beginning the day of pegfilgrastim treatment in patients with pegfilgrastim-induced back and leg pain during the previous treatment cycle Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of pegfilgrastim-induced back and leg pain by administration of the antihistamine loratadine
Patients who experience significant pegfilgrastim-induced back and leg pain during the first cycle of pegfilgrastim therapy are randomized to receive loratadine or placebo during the second cycle of pegfilgrastim therapy
Measured: one week after pegfilgrastim
Secondary outcomes (2)
Identification of adverse events when loratadine is given to prevent pegfilgrastim-induced back and leg pain
Adverse events will be recorded for patients receiving loratadine or placebo to prevent pegfilgrastim-induced back and leg pain
Measured: one week after pegfilgrastim
Incidence of pegfilgrastim-induced back and leg pain
Patients receiving pegfilgrastim for the first time will be surveyed to document the incidence of significant pegfilgrastim-induced back and leg pain
Measured: One week after pegfilgrastim
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pegfilgrastim-induced Back and Leg PainStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer and Leukemia Group B
- Responsible party
- Principal investigator, Steven Grunberg, University of Vermont
- Investigators
- Steven M Grunberg, MD, Study chair, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311336
- Sponsor's protocol ID
- VCC 1012
- Status last verified
- Jan 2013
- First submitted
- 8 Mar 2011
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moukharskaya J, Abrams DM, Ashikaga T, Khan F, Schwartz J, Wilson K, Verschraegen C, Openshaw T, Valentine J, Eneman J, Unger P, Ades S. Randomized phase II study of loratadine for the prevention of bone pain caused by pegfilgrastim. Support Care Cancer. 2016 Jul;24(7):3085-93. doi: 10.1007/s00520-016-3119-0. Epub 2016 Feb 19.
PubMed 26894485
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Pilot Study of Loratadine for the Prevention of Pain Caused by the Granulocyte Colony Stimulating Factor Pegfilgrastim
- ClinicalTrials.gov ID
- NCT01311336
- Acronym / sponsor ID
- VCC 1012
- Conditions
- Pegfilgrastim-induced Back and Leg Pain
- Keywords
- Pegfilgrastim, Loratadine, Myalgia/arthralgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Cancer and Leukemia Group B
- Study start
- May 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 9 Mar 2011 (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.
The purpose of this study is to determine the incidence of pegfilgrastim-induced back and leg pain and to determine whether the antihistamine loratadine can prevent pegfilgrastim-induced back and leg pain.
Detailed description
Pegfilgrastim is a myeloid growth factor that stimulates neutrophil precursors and can be used to decrease infection risk associated with neutropenia. However pegfilgrastim may induce back and leg pain in 20-50% of patients. No intervention has been consistently successful in treating or preventing this pain.
The exact mechanism of pegfilgrastim-induced pain is unknown but may be related to histamine-mediated inflammation. Several case reports and anecdotal reports have suggested efficacy of antihistamines for this indication.
This study will have two parts. In the first part (Observational Phase), patients receiving pegfilgrastim will be surveyed to document the incidence of significant pegfilgrastim-induced back and leg pain. In the second part (Treatment Phase), patients who previously experienced such pain will be randomized to receive a 7-day course of either the antihistamine loratadine or placebo to determine whether pegfilgrastim-induced back and leg pain can be prevented with this intervention.
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 |
|---|---|---|
| Loratadine | Active comparator | Drug: LoratadineLoratadine 10 mg once a day for 7 days beginning the day of pegfilgrastim treatment in patients with pegfilgrastim-induced back and leg pain during the previous treatment cycle |
| Placebo | Placebo comparator | Drug: placeboPlacebo once a day for 7 days beginning the day of pegfilgrastim treatment in patients with pegfilgrastim-induced back and leg pain during the previous treatment cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- histologic or cytologic evidence of malignancy
- scheduled to receive pegfilgrastim with two consecutive cycles of similar chemotherapy with at least a 14 day interval between cycles
- adequate renal function: estimated creatinine clearance > 30 ml/min
- adequate hepatic function: AST, ALT, total bilirubin <= 2.5 x ULN
- age >= 18 years
Key exclusion criteria (4 listed)
- history of hypersensitivity or intolerance to antihistamines
- concurrent use of antihistamines other than study medications during or for 2 days prior to the study period except for a single dose of antihistamine as required for administration of chemotherapy or blood transfusion
- concomitant use of amiodarone
- previous use of pegfilgrastim or filgrastim
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 |
|---|---|---|
| LoratadineAlso: Claritinloratadine 10 mg capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim | Drug | Loratadine |
| placeboplacebo capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim | Drug | Placebo |
Primary outcome
Prevention of pegfilgrastim-induced back and leg pain by administration of the antihistamine loratadine
Time frame: one week after pegfilgrastim
Patients who experience significant pegfilgrastim-induced back and leg pain during the first cycle of pegfilgrastim therapy are randomized to receive loratadine or placebo during the second cycle of pegfilgrastim therapy
2 secondary outcomes
Identification of adverse events when loratadine is given to prevent pegfilgrastim-induced back and leg pain
Time frame: one week after pegfilgrastim
Incidence of pegfilgrastim-induced back and leg pain
Time frame: One week after pegfilgrastim
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
- Derived from this study: PubMed 26894485Moukharskaya J, Abrams DM, Ashikaga T, Khan F, Schwartz J, Wilson K, Verschraegen C, Openshaw T, Valentine J, Eneman J, Unger P, Ades S. Randomized phase II study of loratadine for the prevention of bone pain caused by pegfilgrastim. Support Care Cancer. 2016 Jul;24(7):3085-93. doi: 10.1007/s00520-016-3119-0. Epub 2016 Feb 19.
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.
Steven M Grunberg, MD study chair
University of Vermont
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Loratadine in people with Pegfilgrastim-induced Back and Leg Pain, run by University of Vermont at 7 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?
The sponsor lists 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven M Grunberg, MD (802-656-5457, steven.grunberg@uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of pegfilgrastim-induced back and leg pain by administration of the antihistamine loratadine (time frame: one week after pegfilgrastim). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01311336, which also lists 1 linked publication.
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 24 Jan 2013.