Anamorelin Hydrochloride, Physical Activity, and Nutritional Counseling in Decreasing Cancer-Related Fatigue in Patients With Incurable Metastatic or Recurrent Solid Tumors
Condition: Advanced Malignant Solid Neoplasm; C-Reactive Protein Measurement; Cancer Fatigue; Metastatic Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm; Weight Loss
MeSH terms: Neoplasms; Fatigue; Weight Loss
Intervention: Anamorelin Hydrochloride; Exercise Intervention; Laboratory Biomarker Analysis; Nutritional Assessment; Quality-of-Life Assessment; Questionnaire Administration
Intervention description: Given PO; Undergo physical activity; Correlative studies; Undergo nutritional counseling; Ancillary studies; Ancillary studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well anamorelin hydrochloride, physical activity, and
      nutritional counseling work in decreasing cancer-related fatigue in patients with incurable
      solid tumors that have spread to other parts of the body or have come back. Anamorelin
      hydrochloride, physical activity, and nutritional counseling may help to decrease
      cancer-related fatigue in patients with solid tumors.
    

Eligibility criteria:

        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