Dexamethasone in Controlling Dyspnea in Patients With Cancer

NCT03367156 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2017-0591NCI-2018-01129
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 3

Brief Summary

This phase II trial studies how well dexamethasone works in controlling dyspnea in patients with cancer. Dexamethasone may help control dyspnea (shortness of breath) and improve lung function and quality of life in cancer patients.

Conditions

Dyspnea; Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Intensity

  The average dyspnea intensity over the past 24 hours was assessed daily using a validated numeric rating scale from 0 to 10. The total score ranged from 0-10 where higher scores indicate worse dyspnea. The change in Dyspnea scores between Baseline and Day 7 were measured. Linear model analysis was used for analysis.

  Baseline and Day 7

Secondary Outcomes (7)

• Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Intensity

  Baseline and Day 14

• Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Unpleasantness

  Baseline and Day 7

• Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 7

  Baseline and Day 7

• Change in European Organization for Research and Treatment of Cancer-Quality of Life (EORTC QLQ-C30) Dyspnea Score Between Baseline and Day 7

  Baseline and Day 7

• Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Unpleasantness

  Baseline and Day 14

Study Arms (2)

Group I (dexamethasone)

EXPERIMENTAL

Patients receive dexamethasone PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity.

Drug: Dexamethasone; Other: Questionnaire Administration

Group II (placebo, dexamethasone)

ACTIVE COMPARATOR

Patients receive placebo PO BID on days 1-14 and dexamethasone PO BID on days 15-28 in the absence of disease progression or unacceptable toxicity.

Drug: Dexamethasone; Other: Placebo; Other: Questionnaire Administration

Interventions

Dexamethasone DRUG

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, Fluorodelta, Fortecortin, Gammacorten, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex

Group I (dexamethasone); Group II (placebo, dexamethasone)

Placebo OTHER

Given PO

Also known as: placebo therapy, PLCB, sham therapy

Group II (placebo, dexamethasone)

Questionnaire Administration OTHER

Ancillary studies

Group I (dexamethasone); Group II (placebo, dexamethasone)

Eligibility Criteria

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

You may qualify if:

• Diagnosis of cancer.
• Dyspnea with an average intensity \>= 4 on the dyspnea NRS (range 0-10) over the past week.
• Radiologic suspicion of thoracic involvement, such as primary or metastatic lung cancer, lymphangitic carcinomatosis, airway infiltration, lymphadenopathy, pleural or chest wall invasion.
• Seen at an outpatient clinic at MD Anderson Cancer Center or Lyndon B. Johnson (LBJ) Hospital General Oncology Clinic.
• Able to communicate in English or Spanish.
• Karnofsky performance status \>= 30%.

You may not qualify if:

• Delirium (i.e., score \> 13 on the Memorial Delirium Assessment Scale; range 1-30).
• Oxygen saturation \< 90% despite supplemental oxygen \> 6 L/minute.
• Previous allergic reactions to dexamethasone.
• Diagnosis of diabetes mellitus uncontrolled with oral hypoglycemic agents or insulin.
• Postsurgical open wound that has not healed at the time of enrollment.
• Any infection requiring antibiotics at the time of study enrollment.
• Major surgery within the past 2 weeks.
• Megestrol use at the time of study enrollment.
• Neutropenia (absolute neutrophil count \< 1.0 x 10\^9/L) at the time of study enrollment (bloodwork is not required if patient did not have chemotherapy within past 2 weeks).
• Currently receiving or expected to start cytotoxic chemotherapy or immunotherapy within 1 week of study enrollment and additional dexamethasone cannot be used concurrently as per attending oncologist.
• Severe anemia (hemoglobin \< 8 g/L) not corrected prior to study enrollment (bloodwork is not required if patient did not have chemotherapy within past 2 weeks).
• Chronic obstructive pulmonary disease (COPD) exacerbation at the time of study enrollment.
• Heart failure exacerbation at the time of study enrollment.
• Expected to undergo therapeutic thoracentesis in the next 2 weeks.
• High anxiety score (\>= 15/21) on the Hospital Anxiety and Depression Scale (HADS).

Sponsors & Collaborators

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

Study Sites (3)

Lyndon B. Johnson Hospital

Houston, Texas, 77026, United States

Location

Harris Health System Settegast Health Center

Houston, Texas, 77028, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Hui D, Puac V, Shelal Z, Dev R, Hanneman SK, Jennings K, Ma H, Urbauer DL, Shete S, Fossella F, Liao Z, Blumenschein G Jr, Chang JY, O'Reilly M, Gandhi SJ, Tsao A, Mahler DA, Bruera E. Effect of dexamethasone on dyspnoea in patients with cancer (ABCD): a parallel-group, double-blind, randomised, controlled trial. Lancet Oncol. 2022 Oct;23(10):1321-1331. doi: 10.1016/S1470-2045(22)00508-3. Epub 2022 Sep 7.

  PMID: 36087590 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Dyspnea; Neoplasms

Interventions

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

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: Dr. David Hui- Professor, Palliative Care Medicine
• Organization: UT MD Anderson Cancer Center

dhui@mdanderson.org

(713) 792-6258

Study Officials

• David Hui

  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: December 4, 2017
• First Posted: December 8, 2017
• Study Start: December 4, 2017
• Primary Completion: May 5, 2021
• Study Completion: December 31, 2025
• Last Updated: November 12, 2025
• Results First Posted: December 21, 2022

Record last verified: 2025-11

Locations

US (3)