PainNCT00217724
Glutamine in Preventing Myalgia and/or Arthralgia in Patients Who Are Receiving Paclitaxel For Cancer
A study testing glutamine in people with Pain and Unspecified Adult Solid Tumor, Protocol Specific, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Nutritional supplements, such as glutamine, may prevent side effects caused by chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Pain, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- glutamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1999to Mar 2009
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed patient consent
- Adult patients (Age > 18 years old) with a neoplastic disorder requiring paclitaxel as part of therapy, whether curative or palliative intent.
- Patients must have > 2 additional planned courses of paclitaxel.
- Patients may be out-patient or in-patient at the time of enrollment.
- Patient must have had myalgias and/or arthralgias with the most recent course(s) of paclitaxel. Paclitaxel must be being administered over 3 hours or less for each infusion.
- Patients may have chronic pain but they must be able to differentiate it from either myalgias or arthralgias and be on a stable medication regimen for pain management.
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- Eastern Cooperative Group (ECOG) Performance status score < 3
- If consenting for the laboratory portion of the study the participant must have normal creatinine phosphokinase within 14 days of study entry.
- The patient, if sexually active, must be willing to agree to use an approved form of birth control.
Who cannot join
- The patient has received another investigational drug within the past 30 days.
- No myalgias or arthralgias in prior paclitaxel courses.
- The patient has uncontrolled (over the last 30 days), clinically significant confounding medical conditions such as rheumatoid disease, fibromyalgia, or chronic fatigue syndrome. Also if the patient has a viral infection, cold symptoms, fever (> 38 C -degrees celsius) or influenza.
- Patients with existing neuropathies or neurologic disorders which would prevent them from accurately assessing the onset or extent of myalgias and arthralgias.
- The patient has had significant medical intervention in the last 30 days
- The patient is pregnant or lactating.
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- Patients who are unable to take oral medications or with medical conditions that might inhibit their ability to absorb protein from the gastrointestinal tract.
- Patients who are unwilling to abstain from additional protein supplements of any kind other than that obtained through "normal" dietary intake.
- Patients required to take nonsteroidal anti-inflammatory agents (NSAIDS), antioxidant vitamins, and unable or unwilling to abstain from them for 1 week prior to and during glutamine/placebo therapy.
- Patients with metabolic errors or abnormalities of protein metabolism.
- Patients with a history of blood urea nitrogen level > 2 times normal with a normal serum creatinine.
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239-3098
About this study
Official title: A Double-blinded Pilot Study of Glutamine for the Prevention of Paclitaxel-Induced Myalgias and Arthralgias
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Nutritional supplements, such as glutamine, may prevent side effects caused by chemotherapy.
PURPOSE: This randomized clinical trial is studying glutamine to see how well it works compared to placebo in preventing myalgia and/or arthralgia in patients who are receiving paclitaxel for cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the efficacy of glutamine supplementation vs placebo, in terms of prevention of paclitaxel-induced myalgia and/or arthralgia, in patients with cancer.
Secondary
- Compare the attenuation of myalgia and/or arthralgia in patients who experience myalgia and/or arthralgia treated with these regimens.
OUTLINE: This is a randomized, double-blind, crossover, pilot study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning on day 2 of course 1 of paclitaxel administration, patients receive oral glutamine three times daily for 4 days.
- Arm II: Beginning on day 2 of course 1 of paclitaxel administration, patients receive oral placebo three times daily for 4 days.
Both arms crossover during course 2. In both arms, treatment continues in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed for 7-10 days.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
- Being tested
- glutamine, placebo
- Keywords
- unspecified adult solid tumor, protocol specific, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glutamineDietary supplement
Given orally
placeboOther
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Glutamine Arm | Experimental | Beginning on day 2 of course 1 of paclitaxel administration, patients receive oral glutamine three times daily for 4 days. Receives: Dietary Supplement: glutamine |
| Placebo arm | Placebo comparator | Beginning on day 2 of course 1 of paclitaxel administration, patients receive oral placebo three times daily for 4 days. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy
Complete Response (CR): Complete absence of myalgias or arthralgias Partial Response (PR): Myalgias and/or arthralgias occur but are attenuated in the cycle in which they receive active therapy by > 50% Stable Disease (SD): Less than 25% change in incidence, duration, or severity of myalgias/arthralgias Progressive Disease (PD): Symptoms worsen by >25% from baseline scores
Measured: 2 courses of chemotherapy (6 weeks)
Secondary outcomes (1)
Number of Participants With Attenuation of Myalgias or Arthralgias Not Receiving Glutamine as Measured by Pain Scale Diaries on Days 1 and 3 of Courses 1 and 2
Measured: Duration of participation on study (up to one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 1999
- Primary completionJan 2009
- Study completionMar 2009
Why it stopped: Only able to accrue just 18 of the 40 target \& funds were limited.
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 PainStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Bubalo, OHSU Knight Cancer Institute
- Investigators
- Joseph Bubalo, PharmD, BCPS, BCOP, Study chair, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217724
- Sponsor's protocol ID
- CDR0000446073
- Other IDs
- OHSU-ONC-99037-L, 1252
- Status last verified
- May 2017
- First submitted
- 20 Sep 2005
- Last updated
- 9 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded Pilot Study of Glutamine for the Prevention of Paclitaxel-Induced Myalgias and Arthralgias
- ClinicalTrials.gov ID
- NCT00217724
- Acronym / sponsor ID
- CDR0000446073
- Keywords
- unspecified adult solid tumor, protocol specific, pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Only able to accrue just 18 of the 40 target \& funds were limited.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Study start
- Jul 1999
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 24 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Nutritional supplements, such as glutamine, may prevent side effects caused by chemotherapy.
PURPOSE: This randomized clinical trial is studying glutamine to see how well it works compared to placebo in preventing myalgia and/or arthralgia in patients who are receiving paclitaxel for cancer.
Detailed description
OBJECTIVES:
Primary
- Compare the efficacy of glutamine supplementation vs placebo, in terms of prevention of paclitaxel-induced myalgia and/or arthralgia, in patients with cancer.
Secondary
- Compare the attenuation of myalgia and/or arthralgia in patients who experience myalgia and/or arthralgia treated with these regimens.
OUTLINE: This is a randomized, double-blind, crossover, pilot study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning on day 2 of course 1 of paclitaxel administration, patients receive oral glutamine three times daily for 4 days.
- Arm II: Beginning on day 2 of course 1 of paclitaxel administration, patients receive oral placebo three times daily for 4 days.
Both arms crossover during course 2. In both arms, treatment continues in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed for 7-10 days.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glutamine Arm | Experimental | Dietary Supplement: glutamineBeginning on day 2 of course 1 of paclitaxel administration, patients receive oral glutamine three times daily for 4 days. |
| Placebo arm | Placebo comparator | Other: placeboBeginning on day 2 of course 1 of paclitaxel administration, patients receive oral placebo three times daily for 4 days. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed patient consent
- Adult patients (Age > 18 years old) with a neoplastic disorder requiring paclitaxel as part of therapy, whether curative or palliative intent.
- Patients must have > 2 additional planned courses of paclitaxel.
- Patients may be out-patient or in-patient at the time of enrollment.
- Patient must have had myalgias and/or arthralgias with the most recent course(s) of paclitaxel. Paclitaxel must be being administered over 3 hours or less for each infusion.
Key exclusion criteria (11 listed)
- The patient has received another investigational drug within the past 30 days.
- No myalgias or arthralgias in prior paclitaxel courses.
- The patient has uncontrolled (over the last 30 days), clinically significant confounding medical conditions such as rheumatoid disease, fibromyalgia, or chronic fatigue syndrome. Also if the patient has a viral infection, cold symptoms, fever (> 38 C -degrees celsius) or influenza.
- Patients with existing neuropathies or neurologic disorders which would prevent them from accurately assessing the onset or extent of myalgias and arthralgias.
- The patient has had significant medical intervention in the last 30 days
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 |
|---|---|---|
| glutamineGiven orally | Dietary supplement | Glutamine Arm |
| placeboGiven orally | Other | Placebo arm |
Primary outcome
Number of Participants With Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy
Time frame: 2 courses of chemotherapy (6 weeks)
Complete Response (CR): Complete absence of myalgias or arthralgias Partial Response (PR): Myalgias and/or arthralgias occur but are attenuated in the cycle in which they receive active therapy by > 50% Stable Disease (SD): Less than 25% change in incidence, duration, or severity of myalgias/arthralgias Progressive Disease (PD): Symptoms worsen by >25% from baseline scores
1 secondary outcome
Number of Participants With Attenuation of Myalgias or Arthralgias Not Receiving Glutamine as Measured by Pain Scale Diaries on Days 1 and 3 of Courses 1 and 2
Time frame: Duration of participation on study (up to one year)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joseph Bubalo, PharmD, BCPS, BCOP study chair
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glutamine in people with Pain and Unspecified Adult Solid Tumor, Protocol Specific, run by OHSU Knight Cancer Institute 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 9 inclusion and 11 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 9 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 24 Sep 2010). 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 Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy (time frame: 2 courses of chemotherapy (6 weeks)). 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 9 May 2017.