| Exclusion Criteria: | 1) Males (Prevalence of male breast cancer is low <1%] and there is a gender difference in aggresiveness of the cancer and the level of fatigue);
2) History of carnitine therapy or any use of carnitine supplements 3 months prior to Screening;
3) Use any medication to treat or manage fatigue (e.g., erythropoietin) and pain (morphine or morphine-derivative medications);
4) Requires use of erythropoietin to control anemia;
5) Clinical evidence of hypothyroidism or hyperthyroidism as determined by thyroid function test results (such as serum TSH, FT4E and/or FT3E);
6) History of severe psychiatric illness including major depression that required treatment and/or hospitalization (e.g., mood disorders);
7) Clinical evidence of severe depression (Clinical Evaluation Scale of Depression [CES-D] score of 27 or greater). Mild or moderate depression treatment is allowed with documentation of treatment dosage (e.g., tricyclic antidepressants, serotonin antagonist receptor modulators);
8) Have insomnia of Common Terminology Criteria for Adverse Events (CTCAE) grade II or higher;
9) Have anorexia of CTCAE grade II or higher;
10) Have nausea or vomiting of CTCAE grade II or higher;
11) History of active alcoholism or drug abuse;
12) Have creatinine levels > 2 x Upper Limit of Normal (ULN);
13) Have serum calcium levels > 2 x ULN;
14) Have clinically significant weight loss within the month prior to the study;
15) Have clinical evidence of metastatic breast cancer;
16) Pregnant or lactating females. Women of childbearing potential must use accepted and effective methods of contraception;
17) Current morphine or morphine derivative use is prohibited; however, post-operative analgesics and acetaminophen are acceptable;
18) Use of the following concomitant medications is also prohibited: a. Concurrent use of any cytotoxic therapy for cancer; b. Other investigational drugs; c. Psychostimulants (methylphenidate, modafinil, pemoline, etc); d. Progestational agents (medroxyprogesterone acetate, etc); e. Corticosteroids (methylprednisolone, prednisone); f. Megestrol acetate; g. Erythropoietin; h. Carnitine containing compounds (L-C, ALC tablets, liquid, or capsules). **Subjects taking a prohibited medication other than those mentioned in #18 may enter the Screening period after a 28-day wash-out period.
19) The following wash-out periods are required prior to collection of Baseline ratings and randomization: a. Carnitine - a minimum of 3 months wash-out before being re-screened; b. Stimulants - a minimum of 2 weeks withdrawal period; c. Antipsychotics and neuroleptics - a minimum of 6 months withdrawal period; d. Other psychotropic medication - a minimum of 4 weeks withdrawal period
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