Role of Beta-Endorphin in Cancer Therapy Fatigue

NCT01113905 | Terminated DMC

• 1 other identifier: 09-222
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Breast Cancer; Fatigue

Keywords

Fatigue; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• correlation of endorphin level to fatigue questionnaire results

  one year

Study Arms (2)

Radiation Only

Radiation and Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients who plan to have radiation therapy only or radiation therapy and chemotherapy after their mastectomy or lumpectomy.

You may qualify if:

• 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:
• 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)

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples to be measured for levels of beta-endorphin

MeSH Terms

Conditions

Breast Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David E Fisher, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Dept of Dermatology

Study Record Dates

• First Submitted: April 28, 2010
• First Posted: April 30, 2010
• Study Start: December 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2014
• Last Updated: August 7, 2014

Record last verified: 2014-08

Locations

US (1)