Physical Activity With or Without Dexamethasone in Reducing Cancer-Related Fatigue in Participants With Advanced, Metastatic, or Recurrent Cancer

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03583255

Collaborator

National Cancer Institute (NCI) (NIH), National Institute of Nursing Research (NINR) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical research study is to learn about the effects of combining physical activity with dexamethasone to treat fatigue in patients with advanced cancer.

In this study, dexamethasone will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

This is an investigational study. Dexamethasone is FDA approved and commercially available for the treatment of loss of appetite, tiredness, pain, and nausea. It is investigational to combine dexamethasone and exercise to treat fatigue in advanced cancer patients. The study doctor can explain how the study drug is designed to work.

Up to 70 participants will be enrolled in this study. All will take part at MD Anderson.

Condition or Disease	Intervention/Treatment	Phase
Advanced Malignant Neoplasm Cancer Fatigue Metastatic Malignant Neoplasm Recurrent Malignant Neoplasm	Drug: Dexamethasone Behavioral: Exercise Intervention Other: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Supportive Care

Official Title:

A Combination Therapy for Cancer-Related Fatigue in Advanced Cancer Patients

Actual Study Start Date :

Jun 29, 2018

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I (dexamethasone, exercise) Participants receive dexamethasone PO BID for 7 days. Participants also complete resistance training and moderate intensity walking at home for minimum 5 days per week over 4 weeks.	Drug: Dexamethasone Given PO Other Names: Aacidexam Adexone Aknichthol Dexa Alba-Dex Alin Alin Depot Alin Oftalmico Amplidermis Anemul mono Auricularum Auxiloson Baycuten Baycuten N Cortidexason Cortisumman Decacort Decadrol Decadron Decalix Decameth Decasone R.p. Dectancyl Dekacort Deltafluorene Deronil Desamethasone Desameton Dexa-Mamallet Dexa-Rhinosan Dexa-Scheroson Dexa-sine Dexacortal Dexacortin Dexafarma Dexafluorene Dexalocal Dexamecortin Dexameth Dexamethasonum Dexamonozon Dexapos Dexinoral Dexone Dinormon Fluorodelta Fortecortin Gammacorten Hexadecadrol Hexadrol Lokalison-F Loverine Methylfluorprednisolone Millicorten Mymethasone Orgadrone Spersadex Visumetazone Behavioral: Exercise Intervention Complete resistance training and moderate intensity walking
Active Comparator: Arm II (placebo, exercise) Participants receive placebo PO BID for 7 days. Participants also complete resistance training and moderate intensity walking as in Arm I.	Behavioral: Exercise Intervention Complete resistance training and moderate intensity walking Other: Placebo Given PO Other Names: placebo therapy PLCB sham therapy

Arm

Intervention/Treatment

Experimental: Arm I (dexamethasone, exercise)

Participants receive dexamethasone PO BID for 7 days. Participants also complete resistance training and moderate intensity walking at home for minimum 5 days per week over 4 weeks.

Drug: Dexamethasone

Given PO

Other Names:

Aacidexam

Adexone

Aknichthol Dexa

Alba-Dex

Alin

Alin Depot

Alin Oftalmico

Amplidermis

Anemul mono

Auricularum

Auxiloson

Baycuten

Baycuten N

Cortidexason

Cortisumman

Decacort

Decadrol

Decadron

Decalix

Decameth

Decasone R.p.

Dectancyl

Dekacort

Deltafluorene

Deronil

Desamethasone

Desameton

Dexa-Mamallet

Dexa-Rhinosan

Dexa-Scheroson

Dexa-sine

Dexacortal

Dexacortin

Dexafarma

Dexafluorene

Dexalocal

Dexamecortin

Dexameth

Dexamethasonum

Dexamonozon

Dexapos

Dexinoral

Dexone

Dinormon

Fluorodelta

Fortecortin

Gammacorten

Hexadecadrol

Hexadrol

Lokalison-F

Loverine

Methylfluorprednisolone

Millicorten

Mymethasone

Orgadrone

Spersadex

Visumetazone

Behavioral: Exercise Intervention

Complete resistance training and moderate intensity walking

Active Comparator: Arm II (placebo, exercise)

Participants receive placebo PO BID for 7 days. Participants also complete resistance training and moderate intensity walking as in Arm I.

Behavioral: Exercise Intervention

Complete resistance training and moderate intensity walking

Other: Placebo

Given PO

Other Names:

placebo therapy

PLCB

sham therapy

Outcome Measures

Primary Outcome Measures

Feasibility assessed by the proportion of participants completing the intervention [Up to 1 month]
Will estimate 95% confidence intervals for the proportion of patients completing the intervention.
Adherence [Up to 1 month]
Will be calculated as the mean of the % of total prescribed strength training sessions and the % of total prescribed walking regimen minutes completed (exercise), and mean (across all patients) percentage of total prescribed pills taken (study medication) as detailed above. Will estimate 95% confidence intervals for the proportion of patients completing the intervention and the adherence rate.
Patient Satisfaction with PA+DEX [Up to 1 month]
Patients are satisfied with PA+ DEX, based on more than 75% of patients indicating their satisfaction with PA+ DEX with a rating of "somewhat satisfied" or "completely satisfied" as completed on the Satisfaction Assessment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of advanced cancer (defined as metastatic or recurrent incurable cancer) with fatigue >/= 4/10 (0-10 scale) on the Edmonton Symptom Assessment Scale (ESAS)
Presence of fatigue for at least 2 weeks
Normal cognition defined as Memorial Delirium Assessment Scale (MDAS) of </= 13/30
Hemoglobin >10 g/L within 1 week of enrollment in the study
Zubrod performance status </= 2
Life expectancy of >/= 4 months
Able to read, write, and speak English.

Exclusion Criteria:

Patients with a history of hypersensitivity to dexamethasone or having any contraindication to physical activity as determined by the treating physician
Reports of a fall in the past 30 days
Diabetes mellitus, sepsis and/or acute, chronic, or ongoing infections that are currently being treated with systemic antimicrobials
Current, active peptic ulcer disease
Neutropenia as defined by an absolute neutrophil count (ANC) of < 1000 cells/mm
Regular participation in moderate- or vigorous-intensity physical activity for >/= 30 minutes at least 5 times a week and strength training for >/= 2 days
Severe cardiac disease (New York Heart Association functional class III or IV) or coronary artery disease
Patients currently on immunotherapy
Inability to comply with study protocol procedures