Physical Activity and Dexamethasone in Reducing Cancer-Related Fatigue in Patients With Advanced Cancer

NCT02491632 | Active Not Recruiting Phase 2 Results FDA Drug

• 2 other identifiers: 2014-0436NCI-2015-01320
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase II trial studies how well physical activity and dexamethasone work in reducing cancer-related fatigue in patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Dexamethasone is approved for the treatment of tiredness, pain, and nausea. Physical activity may help improve cancer-related fatigue by improvement in symptoms, distress, and overall well-being. It is not yet known whether high dose or low dose dexamethasone combined with physical activity works better in reducing fatigue in patients with advanced cancer.

Conditions

Fatigue; Metastatic Malignant Neoplasm; Recurrent Malignant Neoplasm; Refractory Malignant Neoplasm; Advanced Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Levels at Day 8 and Day 29

  FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) subscale is a 13 item subscale of FACT-G that allows patient to rate the intensity of their fatigue and its related symptoms on a scale of 0 (not at all) to 4 (very much). The total calculated score varied from 0-52 with a lower score indicating a more severe fatigue level. We measured the change in FACIT-F levels between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test.

  Baseline, day 8, day 29

Secondary Outcomes (3)

• Change in Patient Reported Outcome Measurement Information System-Fatigue (PROMIS-F) Total

  Baseline, day 8, day 29

• Change in Edmonton Symptom Assessment Scale (ESAS) Fatigue

  Baseline, day 8, day 29

• Change in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI_SF) Total Score

  Baseline, day 8, day 29

Study Arms (2)

Arm I (high-dose dexamethasone, physical activity)

EXPERIMENTAL

Patients receive high-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.

Drug: Dexamethasone; Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (low dose dexamethasone, physical activity)

EXPERIMENTAL

Patients receive low-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.

Drug: Dexamethasone; Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Questionnaire Administration OTHER

Ancillary studies

Arm I (high-dose dexamethasone, physical activity); Arm II (low dose dexamethasone, physical activity)

Dexamethasone DRUG

Given PO

Also known as: 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

Arm I (high-dose dexamethasone, physical activity); Arm II (low dose dexamethasone, physical activity)

Exercise Intervention BEHAVIORAL

Complete a graded resistance exercise program and a walking regimen

Arm I (high-dose dexamethasone, physical activity); Arm II (low dose dexamethasone, physical activity)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (high-dose dexamethasone, physical activity); Arm II (low dose dexamethasone, physical activity)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (high-dose dexamethasone, physical activity); Arm II (low dose dexamethasone, physical activity)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of advanced cancer (defined as metastatic or recurrent) with fatigue \>= 4/10 (0-10 scale) on the Edmonton Symptom Assessment Scale (ESAS)
• The presence of fatigue for at least 2 weeks
• Normal cognition
• Hemoglobin \> 8 g/L within 1 week of enrollment in the study
• A life expectancy of \>= 4 months
• No evidence of significant anxiety or depression as determined by a total HADS scores of \< 21
• Definition of advanced cancer includes those patients who have metastatic or refractory disease according to their treating oncologist
• Patients must be able to understand, read, write, and speak English or Spanish

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 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
• Will exclude patients with 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Yennurajalingam S, Valero V, Lu Z, Liu DD, Busaidy NL, Reuben JM, Diaz Fleming C, Williams JL, Hess KR, Basen-Engquist K, Bruera E. Combination Therapy of Physical Activity and Dexamethasone for Cancer-Related Fatigue: A Phase II Randomized Double-Blind Controlled Trial. J Natl Compr Canc Netw. 2021 Dec 29;20(3):235-243. doi: 10.6004/jnccn.2021.7066.

  PMID: 34965510 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Fatigue; Neoplasm Metastasis; Recurrence; Neoplasms

Interventions

Dexamethasone; Calcium Dobesilate; auricularum; dexamethasone acetate; dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Pathologic Processes; Disease Attributes

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Sriram Yennu,MD- Professor, Palliative Care Med
• Organization: UT MD Anderson Cancer Center

syennu@mdanderson.org

(713) 792-3938

Study Officials

• Sriram Yennu

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: July 3, 2015
• First Posted: July 8, 2015
• Study Start: August 13, 2015
• Primary Completion: March 28, 2019
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 18, 2026
• Results First Posted: September 21, 2022

Record last verified: 2026-03

Locations

US (1)