NCT03583255

Brief Summary

This phase II/III trial studies how well physical activity with or without dexamethasone works in reducing cancer-related fatigue in patients with cancer that has spread to other places in the body or has come back. Dexamethasone may decrease the body's immune response. Combining physical activity with dexamethasone may help to treat fatigue in patients with cancer.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for phase_2

Timeline
20mo left

Started Jun 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jun 2018Dec 2027

First Submitted

Initial submission to the registry

June 28, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

June 29, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

9.5 years

First QC Date

June 28, 2018

Last Update Submit

December 23, 2025

Conditions

Advanced Malignant Solid NeoplasmHematopoietic and Lymphoid System NeoplasmLocally Advanced Malignant Solid NeoplasmMetastatic Malignant Solid NeoplasmRecurrent Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (3)

  • Feasibility For Participants with Cancer-Related Fatigue (CRF)

    Will be assessed by the proportion of participants completing the intervention. Will estimate 95% confidence intervals for the proportion of patients completing the intervention.

    Up to 1 month

  • Adherence

    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.

    Up to 1 month

  • Satisfaction

    Will estimate 95% confidence intervals for the proportion of patients with a satisfaction rating of "somewhat satisfied" or "completely satisfied."

    Up to 1 month

Study Arms (2)

Arm I (dexamethasone, exercise)

EXPERIMENTAL

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

Drug: DexamethasoneBehavioral: Exercise Intervention

Arm II (placebo, exercise)

ACTIVE COMPARATOR

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

Behavioral: Exercise InterventionOther: Placebo Administration

Interventions

Exercise InterventionBEHAVIORAL

Complete resistance training and moderate intensity walking

Arm I (dexamethasone, exercise)Arm II (placebo, exercise)
Placebo AdministrationOTHER

Given PO

Arm II (placebo, exercise)
DexamethasoneDRUG

Given PO

Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, 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, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Dxevo, Fluorodelta, Fortecortin, Gammacorten, Hemady, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex
Arm I (dexamethasone, exercise)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of locally advanced cancer (defined as metastatic or recurrent cancer or completed 2 lines of therapy) 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 completed in person or via video conference
  • Hemoglobin \> 8 g/L within 2 weeks of enrollment in the study
  • Zubrod performance status =\< 2
  • Life expectancy of \>= 4 months
  • Able to read, write, and speak English

You may not qualify if:

  • 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
  • Uncontrolled diabetes mellitus as defined by a random blood sugar of \> 200 mg/dl not being monitored by their primary care physician
  • 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
  • Symptomatic 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Yennurajalingam S, Valero V, Smalgo BG, Overman MJ, Dasari A, Wolff RA, Raghav KPS, Barcenas CH, Busaidy NL, Fellman B, Basen-Engquist K, Hess KR, Tripathy D, Bruera E. Physical Activity and Dexamethasone for Cancer-Related Fatigue: A Preliminary Placebo-Controlled, Randomized, Double-Blind Trial. J Natl Compr Canc Netw. 2025 Jan 7;23(1):e247071. doi: 10.6004/jnccn.2024.7071.

    PMID: 39773433DERIVED

Related Links

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

DexamethasoneCalcium Dobesilateauricularumdexamethasone acetatedexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Sriram Yennu

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2018

First Posted

July 11, 2018

Study Start

June 29, 2018

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations

US(1)