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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-29

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To test the hypotheses that patients with cancer-related fatigue (CRF) will be satisfied with the physical activity + dexamethasone (PA+ DEX) intervention, have adequate rates of adherence, and that PA+ DEX will be feasible for patients with CRF.

Ia. To determine if the combination of PA+ DEX is a feasible intervention for advanced cancer patients, as evidenced by an adherence rate to daily use of PA+ DEX greater than or equal to 75%.

Ib. To determine if 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."

SECONDARY OBJECTIVES:

I. To test the hypothesis that PA+ DEX (PA for 4 weeks plus dexamethasone 4 mg twice a day for 1 week) will be more efficacious than PA+ placebo (PA for 4 weeks plus placebo for 1 week) on CRF as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F).

Ia. To determine if PA+ DEX results in robust reduction in FACIT-F subscale scores (defined as \>= 10 point improvement in 60% of patients).

II. To explore the effects of PA+ DEX on fatigue-related symptoms and function. IIa. To determine if PA+ DEX improves CRF by targeting the various associated factors of CRF.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive dexamethasone orally (PO) twice daily (BID) for 7 days. Patients also complete resistance training and moderate intensity walking at home for minimum 5 days per week over 4 weeks.

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

After completion of study, patients are followed up at 29 days and 1 month.

Conditions

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Advanced Malignant Solid Neoplasm Hematopoietic and Lymphoid System Neoplasm Locally Advanced Malignant Solid Neoplasm Metastatic Malignant Solid Neoplasm Recurrent Malignant Solid Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm I (dexamethasone, exercise)

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.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Given PO

Exercise Intervention

Intervention Type BEHAVIORAL

Complete resistance training and moderate intensity walking

Arm II (placebo, exercise)

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

Group Type ACTIVE_COMPARATOR

Exercise Intervention

Intervention Type BEHAVIORAL

Complete resistance training and moderate intensity walking

Placebo Administration

Intervention Type OTHER

Given PO

Interventions

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Dexamethasone

Given PO

Intervention Type DRUG

Exercise Intervention

Complete resistance training and moderate intensity walking

Intervention Type BEHAVIORAL

Placebo Administration

Given PO

Intervention Type OTHER

Other Intervention Names

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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

Eligibility Criteria

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Inclusion Criteria

* 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

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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No