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

• Status: Active, not recruiting
• Trial end date: 2021-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: Helsinn Healthcare SA; National Cancer Institute (NCI)

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