Dexamethasone in Controlling Dyspnea in Patients With Cancer

• ClinicalTrials.gov Identifier: NCT03367156
• Recruitment Status: Active, not recruiting
• First Posted: December 8, 2017
• Results First Posted: December 21, 2022
• Last Update Posted: December 21, 2022
• Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Tracking Information

• First Submitted Date: December 4, 2017
• First Posted Date: December 8, 2017
• Results First Submitted Date: September 22, 2022
• Results First Posted Date: December 21, 2022
• Last Update Posted Date: December 21, 2022
• Actual Study Start Date: December 4, 2017
• Actual Primary Completion Date: May 5, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 22, 2022)

Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Intensity [ Time Frame: Baseline and Day 7 ]

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.

Original Primary Outcome Measures (submitted: December 4, 2017)

Intensity of Dyspnea [ Time Frame: Day 7 ]

Intensity of Dyspnea determined by numeric rating scale (NRS).

Current Secondary Outcome Measures (submitted: September 22, 2022)

• Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Intensity [ Time Frame: Baseline and Day 14 ]
  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 14 were measured. Linear model analysis was used for analysis.
• Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Unpleasantness [ Time Frame: Baseline and Day 7 ]
  The average dyspnea unpleasantness 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 unpleasantness scores between Baseline and Day 7 were measured. Linear model analysis was used for analysis.
• Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 7 [ Time Frame: Baseline and Day 7 ]
  ESAS (Edmonton Symptom Assessment Scale) is a validated scale ranging from 0 (not at all) to 10 (very much) used to assess 10 symptoms commonly experienced by cancer patients during the previous 24 hours: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep and feeling of well being. The change in ESAS fatigue score between Baseline and Day 7 were measured. Total ESAS fatigue score ranged from 0-10, with a higher score indicating higher fatigue. Linear model analysis was used for analysis.
• Change in European Organization for Research and Treatment of Cancer-Quality of Life (EORTC QLQ-C30) Dyspnea Score Between Baseline and Day 7 [ Time Frame: Baseline and Day 7 ]
  European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) is a well-validated quality-of-life assessment for patients with cancer, consisting of 30 questions that encompass three symptom scales (pain, fatigue, and nausea/vomiting) and six questions about single symptoms, as well as five functional scales (physical, cognitive, role, emotional, and social) and one scale assessing global health status/quality of life. Each single symptoms have four response categories (1=not at all, and 4=very much). The change in EORTC fatigue score between Baseline and Day 7 were measured. Total scores using a complex scoring procedures ranges from 0 to 100 with a higher scores indicating higher fatigue. Linear model analysis was used for analysis.
• Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Unpleasantness [ Time Frame: Baseline and Day 14 ]
  The average dyspnea unpleasantness 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 unpleasantness scores between Baseline and Day 14 were measured. Linear model analysis was used for analysis.
• Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 14 [ Time Frame: Baseline and Day 14 ]
  ESAS (Edmonton Symptom Assessment Scale) is a validated scale ranging from 0 (not at all) to 10 (very much) used to assess 10 symptoms commonly experienced by cancer patients during the previous 24 hours: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep and feeling of well being. The change in ESAS fatigue score between Baseline and Day 14 were measured. Total ESAS fatigue score ranged from 0-10, with a higher score indicating higher fatigue. Linear model analysis was used for analysis.
• Change in European Organization for Research and Treatment of Cancer Quality of Life (EORTC) Dyspnea Score Between Baseline and Day 14 [ Time Frame: Baseline and Day 14 ]
  European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) is a well-validated quality-of-life assessment for patients with cancer, consisting of 30 questions that encompass three symptom scales (pain, fatigue, and nausea/vomiting) and six questions about single symptoms, as well as five functional scales (physical, cognitive, role, emotional, and social) and one scale assessing global health status/quality of life. Each single symptoms have four response categories (1=not at all, and 4=very much). The change in EORTC fatigue score between Baseline and Day 14 were measured. Total scores using a complex scoring procedures ranges from 0 to 100 with a higher scores indicating higher fatigue. Linear model analysis was used for analysis.

Original Secondary Outcome Measures (submitted: December 4, 2017)

• Personalized Dyspnea Response [ Time Frame: Day 7 and 14 ]
  Personalized dyspnea response based on a personalized dyspnea goal.
• Difference in Dyspnea numeric rating scale (NRS) [ Time Frame: Baseline to Day 7 ]
  >1.0 considered clinically significant.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dexamethasone in Controlling Dyspnea in Patients With Cancer
• Official Title: A Randomized Controlled Trial of Dexamethasone for Dyspnea in Cancer Patients
• 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.

Detailed Description

PRIMARY OBJECTIVES:

I. Compare the intensity of dyspnea (numeric rating scale [NRS]) in the dexamethasone arm with that in the placebo arm at week 1.

SECONDARY OBJECTIVES:

I. Compare the effects of dexamethasone with those of placebo in terms of personalized dyspnea response (based on a personalized dyspnea goal), unpleasantness of dyspnea, other symptoms, health-related quality of life, respiratory physiologic function, and adverse effects at week 1 and week 2, as well as the intensity of dyspnea at week 2.

II. Identify predictive markers of dyspnea response to dexamethasone.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive dexamethasone orally (PO) twice daily (BID) on days 1-28 in the absence of disease progression or unacceptable toxicity.

GROUP II: 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.

After completion of study treatment, patients are followed up at days 28 and 42.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Supportive Care

Condition

• Dyspnea
• Malignant Neoplasm

Intervention

• Drug: Dexamethasone
  Given PO
  Other Names:

  • 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
• Other: Placebo
  Given PO
  Other Names:

  • placebo therapy
  • PLCB
  • sham therapy
• Other: Questionnaire Administration
  Ancillary studies

Study Arms

• Experimental: Group I (dexamethasone)
  Patients receive dexamethasone PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity.
  Interventions:

  • Drug: Dexamethasone
  • Other: Questionnaire Administration
• Active Comparator: Group II (placebo, dexamethasone)
  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.
  Interventions:

  • Drug: Dexamethasone
  • Other: Placebo
  • Other: Questionnaire Administration

• Publications *: 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 18, 2022): 135
• Original Estimated Enrollment (submitted: December 4, 2017): 231
• Estimated Study Completion Date: December 31, 2023
• Actual Primary Completion Date: May 5, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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%.

Exclusion Criteria:

• 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).
• Chronic systemic corticosteroid use (> 14 days) at the time of study enrollment.
• Any expected corticosteroid use during study enrollment at higher doses than will be used in this study.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03367156
• Other Study ID Numbers: 2017-0591; NCI-2018-01129 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 2017-0591 ( Other Identifier: M D Anderson Cancer Center )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: M.D. Anderson Cancer Center
• Original Responsible Party: Same as current
• Current Study Sponsor: M.D. Anderson Cancer Center
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: David Hui; M.D. Anderson Cancer Center

• PRS Account: M.D. Anderson Cancer Center
• Verification Date: November 2022