Breast Cancer Clinical Trial
Official title:
A Pilot Study Evaluating the Effect of 'R' (Electro-Kinetically Altered Beverage) on Insomnia, Fatigue and Depression in Breast Cancer Patients Receiving Adjuvant Chemotherapy
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.
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