Anamorelin Hydrochloride, Physical Activity, and Nutritional Counseling in Decreasing Cancer-Related Fatigue in Patients with Incurable Metastatic or Recurrent Solid Tumors

Inclusion Criteria

• Patient with a diagnosis of advanced cancer (metastatic or recurrent incurable solid tumors excluding prostate cancer)
• Presence of fatigue on FACIT-F subscale of =< 34 on a 0 to 52 scale (in which 52 = no fatigue and 0 = worst possible fatigue)
• Patient should describe fatigue as being present for a minimum of 2 weeks prior to screening
• CRP must be >= 3 mg/l in the absence of any other more likely cause of increased CRP like an infection or an autoimmune disorder
• No evidence of moderate to severe depression as determined by a HADS depression score of =< 13
• Presence of unintentional weight loss ranging from >= 2 - =< 15% in last 12 months
• Uncontrolled pain; if patient is on opioids for the treatment of cancer pain, he/she must have had no major dose change (> 25%) for at least 48 hours prior to study entry; the dose of morphine equivalent daily should not exceed 120 mg/day unless approved by the principal investigator (PI); change in opioid dose after study entry is allowed
• Patient must be willing to engage in telephone follow up with research staff
• Patient must have telephone access to be contacted by the research staff
• Hemoglobin level of >= 9 g/dL
• Estimated life expectancy of > 4 months at the time of screening
• Aspartate transaminase (AST) and alanine transaminase (ALT) levels =< 5 x upper limit of normal (ULN)

Exclusion Criteria

• Major contraindications to anamorelin e.g. hypersensitivity
• Regularly engaged in moderate or vigorous-intensity exercise for at least 5 times a week
• Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study
• Pregnant or lactating women, childbearing age women who are not on birth control; negative pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last 12 months; pregnancy test to be performed no greater than 14 days prior to consent in study; in cases of women with elevated b-HCG, these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy; women of childbearing potential need to be on or use contraception, or be abstinent during the study period; their male partners must also use contraception (condom) or maintain abstinence; birth controls specifications: women who are able to become pregnant must use birth control during the study and for 30 days after the last anamorelin dose; acceptable forms of birth control include barrier methods (such as condom or diaphragm) with spermicide
• Uncontrolled diabetes mellitus (fasting blood sugar > 200 mg/dl) at screening
• Male patients with a history of untreated hypogonadism
• Patients on drugs with strong CYP 3A4 inhibitors within the previous two weeks (ketoconazole, clarithromycin, itraconazole, nefazodone, telithromycin)
• Patients on drugs that may prolong the PR or QRS interval durations, such as any of the class I/sodium (Na+) channel blocking antiarrhythmic medications should be avoided (e.g. flecainide, procainamide, propafenone, quinidine)
• Patients with untreated clinically relevant hypothyroidism
• Patients currently on investigational therapies will be evaluated by the PI on a case by case basis and study participation approval will be obtained from the treating oncologist
• Patients with prostate cancer