The purpose of this study is to evaluate the effects of consuming "R" on quality of life in the areas of insomnia, fatigue, and depression in female breast cancer patients receiving multi-cycle adjuvant chemotherapy.
Female breast cancer patients eligible for adjuvant therapy with four cycles of Taxotere and Cytoxan chemotherapy after surgery will be enrolled for the study. Eligible subjects will begin to consume either "R" or purified water (placebo) just prior to the 1st cycle of chemotherapy. Subjects will continue to consume either "R" or placebo through Cycle 1, Cycle 2, Cycle 3, Cycle 4, and for an additional 12 weeks after completing chemotherapy. Study procedures will include clinical lab assessments, analysis of inflammatory markers, RNA biomarkers, adverse events, subject diary, and quality of life measurements for insomnia, fatigue and depression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
16
NWMS Bonney Lake - Medical Oncology
Bonney Lake, Washington, United States
NWMS Federal Way - Medical Oncology
Federal Way, Washington, United States
NWMS Gig Harbor - Medical Oncology
Gig Harbor, Washington, United States
NWMS Lakewood - Medical Oncology
Lakewood, Washington, United States
The effects of consuming "R" on quality of life in the areas of insomnia in breast cancer patients receiving multi-cycle adjuvant chemotherapy
SleepMed Insomnia Questionnaire: This is a test to assess, in general, how a subject is feeling about their sleep using a "0-4" point scale - with the "0" representing no problem with sleep and "4" representing a big problem with how a subject feels about the quality of their sleep.
Time frame: Patients will be followed for up to 25 weeks
The effects of consuming "R" on quality of life in the areas of fatigue in breast cancer patients receiving multi-cycle adjuvant chemotherapy
FACIT Fatigue Scale: A list of questions that asks a patient how fatigued they have felt in the last 7 days.
Time frame: Patients will be followed for up to 25 weeks
The effects of consuming "R" on quality of life in the areas of depression in breast cancer patients receiving multi-cycle adjuvant chemotherapy
Beck Depression Inventory-II: A list of statements that ask a subject about the way they have been feeling for the last two weeks.
Time frame: Patients will be followed for up to 25 weeks
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Rainier Hematology-Oncology, WA
Puyallup, Washington, United States
NWMS Tacoma - Medical Oncology & Infectious Diseases
Tacoma, Washington, United States