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Beta-Endorphin as a Mediator of Cancer Therapy-Induced Fatigue


N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Fatigue

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Trial Information

Beta-Endorphin as a Mediator of Cancer Therapy-Induced Fatigue


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:

1. Adjuvant chemotherapy followed by radiation therapy

2. 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.


Inclusion Criteria:



1. Age > 18 years

2. Pathologic diagnosis of stage 0-III breast cancer (any histologic subtype) in either
breast or both breasts

3. Previous resection of tumor, either by mastectomy or partial mastectomy, ±sentinel
lymph node biopsy, ±axillary lymph node dissection

4. A likelihood of having radiation therapy or chemotherapy following surgery as
determined by the on-site principal investigator (PI) or co-investigator

5. 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:

1. Planned 3-D conformal radiation therapy to the whole breast (2 tangential fields,
unilateral or bilateral) via standard or Canadian Fractionation, +/- regional nodal
irradiation.

2. No planned chemotherapy for this tumor

Eligibility for the RT + chemotherapy (CT) group will include:

1. 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.

2. Planned adjuvant chemotherapy (any regimen except for biologic therapy alone)

Exclusion Criteria:

1. 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.

2. Prior radiation therapy to the chest or brain

3. Patients diagnosed with Stage IV breast cancer

4. History of illegal drug use within 6 months prior to enrollment

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. Activity-limiting heart or lung disease

12. Renal failure (BUN and creatinine should be within the normal range for the prior 6
months)

13. 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.

14. Patients receiving chemotherapy or radiation therapy at any site other than
Massachusetts General Hospital

15. 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)

16. 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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Principal Investigator

David E Fisher, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

09-222

NCT ID:

NCT01113905

Start Date:

December 2009

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Fatigue
  • Fatigue
  • Breast Cancer
  • Breast Neoplasms
  • Fatigue

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617