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

What Was Tested

In this phase 2 trial, researchers set out to test Anamorelin (non-peptide).

It had 1 arm (groups): Supportive Care (anamorelin, physical activity, counseling) (experimental).

Patients receive anamorelin hydrochloride PO QD and undergo physical activity consisting of resistance exercises and a home walking program. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo nutritional counseling on day 21.

The registry classes the interventions as behavioral, drug and other.

More on the Plan

To examine the side effects and tolerability of anamorelin in these patients.

To explore the effects of anamorelin on sleep as measured by the Pittsburgh Sleep Quality Index (PSQI).

OUTLINE: Patients receive anamorelin hydrochloride orally (PO) once daily (QD) and undergo physical activity consisting of resistance exercises and a home walking program.

Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

Who Took Part

Enrollment: 129 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. No evidence of moderate to severe depression as determined by a HADS depression score of =\< 13. 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.

The full record lists 12 inclusion and 11 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Anamorelin (non-peptide) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2017-02-08 with completion listed for 2019-12-27.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) (time frame: Baseline up to day 43).

It also tracked 3 secondary outcomes, for example The Edmonton Symptom Assessment Scale (ESAS)-Fatigue, Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], General Fatigue and Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], Physical Fatigue.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Anamorelin (non-peptide) in 129 people.

Its status is active not recruiting; results are posted on the registry, and this page does not restate them.

More context: the Anamorelin (non-peptide) compound page, all human trials.