Breast CancerNCT01113905
Role of Beta-Endorphin in Cancer Therapy Fatigue
An observational study of Breast Cancer and Fatigue, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators aim to test whether beta-endorphin, a substance our bodies make in response to painful and stressful stimuli, plays a causative role in radiation-induced fatigue that cancer patients receiving radiation therapy commonly experience. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Fatigue
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Aug 2014
- 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: Breast cancer patients who plan to have radiation therapy only or radiation therapy and chemotherapy after their mastectomy or lumpectomy.
Who may be able to join
- Age > 18 years
- Pathologic diagnosis of stage 0-III breast cancer (any histologic subtype) in either breast or both breasts
- Previous resection of tumor, either by mastectomy or partial mastectomy, ±sentinel lymph node biopsy, ±axillary lymph node dissection
- A likelihood of having radiation therapy or chemotherapy following surgery as determined by the on-site principal investigator (PI) or co-investigator
- Signed informed consent which has been reviewed and approved by the Institutional Review Board and no condition that impairs the ability to provide informed consent (e.g. uncontrolled psychiatric illness)
- Eligibility for the radiation therapy (RT) alone group will include:
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- Planned 3-D conformal radiation therapy to the whole breast (2 tangential fields, unilateral or bilateral) via standard or Canadian Fractionation, +/- regional nodal irradiation.
- No planned chemotherapy for this tumor
- Eligibility for the RT + chemotherapy (CT) group will include:
- Planned 3-D conformal radiation therapy to the whole breast (2 tangential fields, unilateral or bilateral) via standard or Canadian fractionation (photons followed by a photon, electron, or mixed photon/electron boost), +/- regional nodal irradiation.
- Planned adjuvant chemotherapy (any regimen except for biologic therapy alone)
Who cannot join
- Continuous/chronic treatment with opiate/opioid analgesics for 3-6 months prior to enrollment. In addition, patients receiving radiation therapy alone who have taken opiate analgesics from their surgery within 72 hours of the post-surgery/pre-radiation therapy blood draw (at 1-6 weeks prior to the start of radiation therapy) will be removed from the study. Patients receiving chemotherapy and radiation therapy who have taken opiate analgesics from their surgery within 72 hours of the blood draw prior to cycle 1 of chemotherapy will be removed from the study.
- Prior radiation therapy to the chest or brain
- Patients diagnosed with Stage IV breast cancer
- History of illegal drug use within 6 months prior to enrollment
- At point of enrollment, diagnosis of major depression, bipolar disorder, seasonal affective disorder, or anxiety disorder for which the patient is currently taking any of the following medications: selective serotonin reuptake inhibitors (SSRIs), Tricyclic antidepressants, monoamine oxidase inhibitors, lithium, benzodiazepines, barbiturates, drugs acting on the 5-HT receptors. Patients meeting these criteria may still enroll in the study if they are on a chronic, stable, low-dose regimen for at least 3 months prior to enrollment, as determined by the on-site PIs and co-investigating physicians. Patients having to begin on a regimen of any of these medications while on the study may continue on the study.
- Anemia of any etiology at initial visit (Hct <33%) and the following baseline fatigue scores on the Fatigue Symptom Inventory (FSI): Average score for question #s 1-4 > 5; and/or Average score for question #s 5-11 > 5. Patients with Hct<33% but who have no baseline fatigue (as indicated by baseline scores on the FSI as follows: average score for question #s 1-4 < 5 and average scores for question #s 5-11 < 5) are eligible to participate.
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- Endocrine disorders that can cause fatigue: Addison's disease, uncorrected hypothyroidism (patients taking thyroid replacement therapy for at least 3 months prior to enrollment patients are eligible), central endocrine deficiency, polyglandular autoimmune failure.
- Patients with thyroid disease (hypothyroidism or hyperthyroidism) that was diagnosed within 3 months of cancer diagnosis or patients with previously stable thyroid disease who have experienced symptoms or have had to change their medication doses within 3 months of cancer diagnosis. Patients with stable disease who have no had to change medication doses within 3 months of cancer diagnosis. Patients with stable disease who have not had to change medication doses within 3 months of cancer diagnosis may enroll as long as baseline fatigue scores do not meet criteria for exclusion. Patients enrolled in the study who have to alter doses of thyroid medications or who are newly diagnosed with thyroid disease while on the study will be removed from the study, and will not count towards our total patient accrual.
- Uncontrolled autoimmune diseases that can cause fatigue, including fibromyalgia and fatigue syndromes. If these are controlled, enrollment or maintenance of the patient on the protocol may continue at the discretion of the enrolling principal investigator.
- Sleep disorder diagnosed within 3 months of enrollment and the following baseline fatigue scores on the FSI: Average score for question #s 1-4 > 5; and/or average score for question #s 5-11 > 5. Patients diagnosed with a sleep disorder within 3 months of enrollment and with FSI scores < 5 on question #s 1-4 and #s 5-11 are eligible.
- Activity-limiting heart or lung disease
- Renal failure (BUN and creatinine should be within the normal range for the prior 6 months)
- Baseline fatigue as indicated by the following baseline scores on the FSI: Average score for question #s 1-4 > 5; and/or Average score for question #s 5-11 > 5.
- Patients receiving chemotherapy or radiation therapy at any site other than Massachusetts General Hospital
- Hepatitis or chronic liver disease (albumin <3 g/dL or >6 g/dL; ALT >60 U/L or < 5 U/L, AST > 40 U/L or <5 U/L)
- Untreated chronic infection (e.g. tuberculosis, osteomyelitis, abscess). Patients being treated for these may be enrolled in, or continue on the protocol at the discretion of the principal investigators.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Beta-Endorphin as a Mediator of Cancer Therapy-Induced Fatigue
The investigators aim to test whether beta-endorphin, a substance our bodies make in response to painful and stressful stimuli, plays a causative role in radiation-induced fatigue that cancer patients receiving radiation therapy commonly experience. If this is so, the investigators' hope is to direct efforts at treating radiation-induced fatigue using agents that block the action of beta-endorphin with the aim of improving quality of life for patients undergoing radiation therapy
Read the detailed description
Participants will be breast cancer patients receiving radiation therapy at Massachusetts General Hospital. There will be two groups of patients: those receiving adjuvant radiation therapy alone following surgical tumor resection, and those receiving adjuvant chemotherapy and radiation therapy following surgical tumor resection. Patients receiving any radiation regimen detailed below in section 2b are eligible for the study. In this study the investigators will be drawing blood for beta-endorphin measurement prior to, at various times during, and following patients' treatment regimens. In addition, at each blood draw, patients will complete questionnaires that assess fatigue, mood, and pain. These questionnaires have all been validated for use in cancer patients (see "Procedures Involving Human Participants section below), and for our study, the investigators have formatted them onto computer tablets for ease of patient completion and data analysis. This study will progress as follows:
Patients: Patients expected to receive adjuvant radiation therapy at Massachusetts General Hospital will be approached for enrollment onto this study. Two groups of patients, a chemotherapy group and a non-chemotherapy group, will be enrolled as follows:
- Adjuvant chemotherapy followed by radiation therapy
- Adjuvant radiation therapy without chemotherapy
The enrollment goal for each group is 50 patients (total of 100 patients for the study). This calculation is based on the approximate number of 30 patients the investigators will need to achieve a sensitivity of β-endorphin changes of 5 pM being statistically significant to a p-value of<0.05 with 95% power. Based in our finding in mice, the investigators expect β-endorphin levels to vary between individuals, and the investigators have increased sample size by 70% from our calculations to account for deviations from our β-endorphin levels estimations. Additionally, the investigators have added patients to account for a number of patient dropping out of the study, since this is a long trial for patients requiring multiple blood draws.
- Conditions
- Breast Cancer, Fatigue
- Keywords
- Fatigue, Breast Cancer
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Radiation Only | Not described | |
| Radiation and Chemotherapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of endorphin level to fatigue questionnaire results
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startDec 2009
- Primary completionJul 2013
- Study completionAug 2014
Why it stopped: Insufficient recruitment was obtained
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 Massachusetts General HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David E. Fisher, M.D., Ph.D, Massachusetts General Hospital
- Investigators
- David E Fisher, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113905
- Sponsor's protocol ID
- 09-222
- Status last verified
- Aug 2014
- First submitted
- 28 Apr 2010
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-Endorphin as a Mediator of Cancer Therapy-Induced Fatigue
- ClinicalTrials.gov ID
- NCT01113905
- Acronym / sponsor ID
- 09-222
- Conditions
- Breast Cancer, Fatigue
- Keywords
- Fatigue, Breast Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment was obtained
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 30 Apr 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.
The investigators aim to test whether beta-endorphin, a substance our bodies make in response to painful and stressful stimuli, plays a causative role in radiation-induced fatigue that cancer patients receiving radiation therapy commonly experience. If this is so, the investigators' hope is to direct efforts at treating radiation-induced fatigue using agents that block the action of beta-endorphin with the aim of improving quality of life for patients undergoing radiation therapy
Detailed description
Participants will be breast cancer patients receiving radiation therapy at Massachusetts General Hospital. There will be two groups of patients: those receiving adjuvant radiation therapy alone following surgical tumor resection, and those receiving adjuvant chemotherapy and radiation therapy following surgical tumor resection. Patients receiving any radiation regimen detailed below in section 2b are eligible for the study. In this study the investigators will be drawing blood for beta-endorphin measurement prior to, at various times during, and following patients' treatment regimens. In addition, at each blood draw, patients will complete questionnaires that assess fatigue, mood, and pain. These questionnaires have all been validated for use in cancer patients (see "Procedures Involving Human Participants section below), and for our study, the investigators have formatted them onto computer tablets for ease of patient completion and data analysis. This study will progress as follows:
Patients: Patients expected to receive adjuvant radiation therapy at Massachusetts General Hospital will be approached for enrollment onto this study. Two groups of patients, a chemotherapy group and a non-chemotherapy group, will be enrolled as follows:
- Adjuvant chemotherapy followed by radiation therapy
- Adjuvant radiation therapy without chemotherapy
The enrollment goal for each group is 50 patients (total of 100 patients for the study). This calculation is based on the approximate number of 30 patients the investigators will need to achieve a sensitivity of β-endorphin changes of 5 pM being statistically significant to a p-value of<0.05 with 95% power. Based in our finding in mice, the investigators expect β-endorphin levels to vary between individuals, and the investigators have increased sample size by 70% from our calculations to account for deviations from our β-endorphin levels estimations. Additionally, the investigators have added patients to account for a number of patient dropping out of the study, since this is a long trial for patients requiring multiple blood draws.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiation Only | – | – |
| Radiation and Chemotherapy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients who plan to have radiation therapy only or radiation therapy and chemotherapy after their mastectomy or lumpectomy.
Key inclusion criteria (11 listed)
- Age > 18 years
- Pathologic diagnosis of stage 0-III breast cancer (any histologic subtype) in either breast or both breasts
- Previous resection of tumor, either by mastectomy or partial mastectomy, ±sentinel lymph node biopsy, ±axillary lymph node dissection
- A likelihood of having radiation therapy or chemotherapy following surgery as determined by the on-site principal investigator (PI) or co-investigator
- Signed informed consent which has been reviewed and approved by the Institutional Review Board and no condition that impairs the ability to provide informed consent (e.g. uncontrolled psychiatric illness)
Key exclusion criteria (16 listed)
- Continuous/chronic treatment with opiate/opioid analgesics for 3-6 months prior to enrollment. In addition, patients receiving radiation therapy alone who have taken opiate analgesics from their surgery within 72 hours of the post-surgery/pre-radiation therapy blood draw (at 1-6 weeks prior to the start of radiation therapy) will be removed from the study. Patients receiving chemotherapy and radiation therapy who have taken opiate analgesics from their surgery within 72 hours of the blood draw prior to cycle 1 of chemotherapy will be removed from the study.
- Prior radiation therapy to the chest or brain
- Patients diagnosed with Stage IV breast cancer
- History of illegal drug use within 6 months prior to enrollment
- At point of enrollment, diagnosis of major depression, bipolar disorder, seasonal affective disorder, or anxiety disorder for which the patient is currently taking any of the following medications: selective serotonin reuptake inhibitors (SSRIs), Tricyclic antidepressants, monoamine oxidase inhibitors, lithium, benzodiazepines, barbiturates, drugs acting on the 5-HT receptors. Patients meeting these criteria may still enroll in the study if they are on a chronic, stable, low-dose regimen for at least 3 months prior to enrollment, as determined by the on-site PIs and co-investigating physicians. Patients having to begin on a regimen of any of these medications while on the study may continue on the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
correlation of endorphin level to fatigue questionnaire results
Time frame: one year
Results and safety
The study was stopped early (reason given: Insufficient recruitment was obtained). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
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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.
David E Fisher, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Fatigue, run by Massachusetts General Hospital 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 11 inclusion and 16 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 7 Aug 2014. 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.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment was obtained). 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?
correlation of endorphin level to fatigue questionnaire results (time frame: one year). 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 7 Aug 2014.