Nutritional Assessment for Cancer-Related Fatigue

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cancer-Related Fatigue+5 MoreNutritional Assessment - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing anamorelin hydrochloride, physical activity, and nutritional counseling to see if it can help reduce cancer-related fatigue in patients with incurable solid tumors.

Eligible Conditions
  • Cancer-Related Fatigue
  • Weight Loss
  • Cancer
  • C-Reactive Protein Test
  • Metastatic Cancer
  • Recurrent Malignant Solid Tumor

Treatment Effectiveness

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Up to day 43

Day 43
Change in Functional Assessment of Cancer Illness Therapy-Fatigue subscale score
Change in body composition as measured by INBODY
Change in day time activity as measured by accelerometer
Change in muscle function as measured by the 30 second chair stand test and 6 minute walk test
Change in quality of life
Change in resting energy expenditure as measured by indirect calorimetry
Fatigue
Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], General Fatigue
Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], Physical Fatigue
The Edmonton Symptom Assessment Scale (ESAS)-Fatigue
Up to day 43
Frequency and type of side effects
Inflammatory response of cytokines, c-reactive protein, and IGF-1

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Supportive Care (anamorelin, physical activity, counseling)
1 of 1

Experimental Treatment

129 Total Participants · 1 Treatment Group

Primary Treatment: Nutritional Assessment · No Placebo Group · Phase 2

Supportive Care (anamorelin, physical activity, counseling)Experimental Group · 6 Interventions: Quality-of-Life Assessment, Anamorelin Hydrochloride, Questionnaire Administration, Nutritional Assessment, Exercise Intervention, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Other, Other, Behavioral, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Intervention
2017
Completed Phase 4
~1810

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to day 43

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,803 Previous Clinical Trials
1,790,229 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,073 Previous Clinical Trials
41,138,779 Total Patients Enrolled
Sriram YennuPrincipal InvestigatorM.D. Anderson Cancer Center
12 Previous Clinical Trials
1,583 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
65+50.0%
18 - 6550.0%
What site did they apply to?
M D Anderson Cancer Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "I have tired many other ways to lose this weight and it seems that nothing is working I even went to WW and it wasn't working for me. I have tired many over the counter pills to no success"
How many prior treatments have patients received?
3+100.0%