Pain, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific, pain
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTglutamine
Given orally
OTHERplacebo
Given orally
Sponsors
OHSU Knight Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
. * 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. * 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.
Exclusion criteria
. * 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 | Duration of participation on study (up to one year) |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from oncology clinics at OHSU.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Includes those randomized to Arms 1 and 2 in both course 1 and 2. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 54 years STANDARD_DEVIATION 1 |
| Cancer Diagnosis Breast | 11 Participants |
| Cancer Diagnosis Esophageal | 1 Participants |
| Cancer Diagnosis Ovarian | 5 Participants |
| Cancer Diagnosis Uterine sarcoma | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
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
Time frame: 2 courses of chemotherapy (6 weeks)
Population: Fourteen of the 18 patients enrolled received both cycles of therapy and were thus evaluable for the primary endpoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oral Glutamine x 4 Days | Number of Participants With Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy | Complete Response | 0 participants |
| Oral Glutamine x 4 Days | Number of Participants With Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy | Partial Response | 3 participants |
| Oral Glutamine x 4 Days | Number of Participants With Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy | Stable Disease (SD)/Progressive Disease (PD) | 11 participants |
| Oral Placebo x 4 Days | Number of Participants With Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy | Complete Response | 0 participants |
| Oral Placebo x 4 Days | Number of Participants With Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy | Partial Response | 4 participants |
| Oral Placebo x 4 Days | Number of Participants With Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy | Stable Disease (SD)/Progressive Disease (PD) | 10 participants |
Secondary
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)