Breast CancerPhase 2NCT00112749
Infliximab in Treating Cancer-Related Fatigue in Postmenopausal Women Who Have Undergone Treatment for Breast Cancer
A Phase 2 study testing infliximab, Clinical Assessment and Self-report questionnaires in people with Breast Cancer and Fatigue, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Infliximab may help improve energy levels in patients who have undergone treatment for breast cancer. PURPOSE: This phase II trial is studying how well infliximab works in treating cancer-related fatigue in postmenopausal women who have undergone treatment for stage 0, stage I, or stage II breast cancer. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Fatigue
- What is being tested?
- infliximab, Clinical Assessment and Self-report questionnaires
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Nov 2012
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who report elevated fatigue following cancer diagnosis and treatment
Who cannot join
- Women who have medical conditions that may affect the immune system or are associated with baseline fatigue syndrome, and/or who use medications that affect the immune system or fatigue.
- Women with major affective disorders and those with sleep or pain disorders.
- Presence of medical conditions that may but subject at undue risk for experimental procedures.
- Chronic or recurring infections, symptoms of chronic heart failure, demyelinating disorders, and those taking immunosuppressive medications.
- Neoplastic disease other than primary breast cancer
- Compromised cardiovascular function
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- Insulin-dependent diabetes
- Neurological disorder
- Peripheral neuropathy
- Pregnancy
- Use of psychotropic medications within 2 weeks of screening
- Abnormal screening laboratory findings (i.e., creatinine > 1.4mg%; anemia; abnormal thyroid hormone; hematuria; elevated liver function tests, low protein or albumin; fasting glucose >120mg%; elevated FTI or TSH; positive TB screening, HIV screening or hepatitis C).
- Smokers
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
About this study
Official title: Does Blocking Proinflammatory Cytokines Diminish Cancer-Related Fatigue?
RATIONALE: Infliximab may help improve energy levels in patients who have undergone treatment for breast cancer.
PURPOSE: This phase II trial is studying how well infliximab works in treating cancer-related fatigue in postmenopausal women who have undergone treatment for stage 0, stage I, or stage II breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the association between the body's immune system and energy, sleep, mood, and other symptoms in postmenopausal women who have undergone treatment for stage 0-II breast cancer.
- Determine whether treatment with infliximab affects energy and immune function in these patients.
OUTLINE: Patients receive infliximab IV over 2 hours.
Patients complete a diary twice daily for 14 days before and for 14 days after infliximab administration to assess fatigue and other symptoms, including mood, pain, and sleep.
After completion of study treatment, patients are followed at 2 weeks and then monthly for 3 months.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
- Conditions
- Breast Cancer, Fatigue
- Being tested
- infliximab, Clinical Assessment, Self-report questionnaires, Immune Assessment
- Keywords
- stage I breast cancer, stage II breast cancer, breast cancer in situ, fatigue
- Medical subject headings
- Breast Neoplasms, Fatigue, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infliximabBiological
A single infusion of 1mg/kg will be administered.
Clinical AssessmentOther
Medical, psychiatric, and immune evaluation.
Self-report questionnairesOther
Fatigue Symptom Inventory, Multidimensional Fatigue Symptom Inventory, Hamilton Depression Rating Scale, Beck Depression Inventory II, Hamilton anxiety Rating Scale, Pittsburgh Sleep Quality Index, Brief Pain Inventory, MOS SF-36.
Immune AssessmentOther
Proinflammatory cytokines and markers of cytokine activity and lymphocyte subsets and CBC.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | Please see intervention description Receives: Biological: infliximab; Other: Clinical Assessment; Other: Self-report questionnaires; Other: Immune Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatigue as measured by the fatigue symptom inventory (FSI)
Measured: At baseline and after completion of study treatment, 4 years
Change in fatigue as measured by multidimensional fatigue symptom inventory (MFSI)
Measured: At baseline and after completion of study treatment, 4 years
Secondary outcomes (3)
Change in proinflammatory cytokines as measured by interleukin-1 receptor antagonist value
Measured: At baseline and after completion of study treatment, 4 years
Change in proinflammatory cytokines as measured by interleukin 6 value
Measured: At baseline and after completion of study treatment, 4 years
Change in proinflammatory cytokines as measured by tumor necrosis factor
Measured: At baseline and after completion of study treatment, 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2005 (estimated)
- Study startFeb 2005
- Primary completionJan 2007
- Study completionNov 2012
Why it stopped: Recruitment stopped due to slow accrual and lack of evidence of need for further continuation of protocol in inpatient setting.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Patricia A. Ganz, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112749
- Sponsor's protocol ID
- CDR0000428460
- Other IDs
- UCLA-0410033-01
- Status last verified
- Feb 2016
- First submitted
- 2 Jun 2005
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Blocking Proinflammatory Cytokines Diminish Cancer-Related Fatigue?
- ClinicalTrials.gov ID
- NCT00112749
- Acronym / sponsor ID
- CDR0000428460
- Conditions
- Breast Cancer, Fatigue
- Keywords
- stage I breast cancer, stage II breast cancer, breast cancer in situ, fatigue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment stopped due to slow accrual and lack of evidence of need for further continuation of protocol in inpatient setting.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Feb 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 3 Jun 2005 (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: Infliximab may help improve energy levels in patients who have undergone treatment for breast cancer.
PURPOSE: This phase II trial is studying how well infliximab works in treating cancer-related fatigue in postmenopausal women who have undergone treatment for stage 0, stage I, or stage II breast cancer.
Detailed description
OBJECTIVES:
- Determine the association between the body's immune system and energy, sleep, mood, and other symptoms in postmenopausal women who have undergone treatment for stage 0-II breast cancer.
- Determine whether treatment with infliximab affects energy and immune function in these patients.
OUTLINE: Patients receive infliximab IV over 2 hours.
Patients complete a diary twice daily for 14 days before and for 14 days after infliximab administration to assess fatigue and other symptoms, including mood, pain, and sleep.
After completion of study treatment, patients are followed at 2 weeks and then monthly for 3 months.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Biological: infliximab, Other: Clinical Assessment, Other: Self-report questionnaires, Other: Immune AssessmentPlease see intervention description |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women who report elevated fatigue following cancer diagnosis and treatment
Key exclusion criteria (13 listed)
- Women who have medical conditions that may affect the immune system or are associated with baseline fatigue syndrome, and/or who use medications that affect the immune system or fatigue.
- Women with major affective disorders and those with sleep or pain disorders.
- Presence of medical conditions that may but subject at undue risk for experimental procedures.
- Chronic or recurring infections, symptoms of chronic heart failure, demyelinating disorders, and those taking immunosuppressive medications.
- Neoplastic disease other than primary breast cancer
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 |
|---|---|---|
| infliximabA single infusion of 1mg/kg will be administered. | Biological | Study Arm |
| Clinical AssessmentMedical, psychiatric, and immune evaluation. | Other | Study Arm |
| Self-report questionnairesFatigue Symptom Inventory, Multidimensional Fatigue Symptom Inventory, Hamilton Depression Rating Scale, Beck Depression Inventory II, Hamilton anxiety Rating Scale, Pittsburgh Sleep Quality Index, Brief Pain Inventory, MOS SF-36. | Other | Study Arm |
| Immune AssessmentProinflammatory cytokines and markers of cytokine activity and lymphocyte subsets and CBC. | Other | Study Arm |
Primary outcome
Change in fatigue as measured by the fatigue symptom inventory (FSI)
Time frame: At baseline and after completion of study treatment, 4 years
Change in fatigue as measured by multidimensional fatigue symptom inventory (MFSI)
Time frame: At baseline and after completion of study treatment, 4 years
3 secondary outcomes
Change in proinflammatory cytokines as measured by interleukin-1 receptor antagonist value
Time frame: At baseline and after completion of study treatment, 4 years
Change in proinflammatory cytokines as measured by interleukin 6 value
Time frame: At baseline and after completion of study treatment, 4 years
Change in proinflammatory cytokines as measured by tumor necrosis factor
Time frame: At baseline and after completion of study treatment, 4 years
Results and safety
The study was stopped early (reason given: Recruitment stopped due to slow accrual and lack of evidence of need for further continuation of protocol in inpatient setting.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
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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.
Patricia A. Ganz, MD principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing infliximab, Clinical Assessment and Self-report questionnaires in people with Breast Cancer and Fatigue, run by Jonsson Comprehensive Cancer Center 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 13 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 31 Jul 2020. 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. 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?
The study was stopped early (reason given: Recruitment stopped due to slow accrual and lack of evidence of need for further continuation of protocol in inpatient setting.). 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 fatigue as measured by the fatigue symptom inventory (FSI) (time frame: At baseline and after completion of study treatment, 4 years). The study lists 2 primary outcomes in all. 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 31 Jul 2020.