New combo targets debilitating fatigue in advanced cancer patients
NCT ID NCT03035409
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a drug called anamorelin, combined with physical activity and nutritional counseling, can reduce severe fatigue in people with advanced solid tumors that have spread or returned. About 129 participants with incurable cancers and high fatigue levels will receive the treatment for several weeks. The goal is to improve daily energy and quality of life, not to cure the cancer.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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129 people
The number who actually took part.
- Started
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Feb 2017
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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