Clinical trial NCT03367156: Dexamethasone in Controlling Dyspnea in Patients With Cancer
Official title: A Randomized Controlled Trial of Dexamethasone for Dyspnea in Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Dyspnea
Malignant Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-12-08
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Intensity
timeFrame: Baseline and Day 7
Secondary outcomes:
measure: Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Intensity
timeFrame: Baseline and Day 14
measure: Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Unpleasantness
timeFrame: Baseline and Day 7
measure: Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 7
timeFrame: Baseline and Day 7
measure: Change in European Organization for Research and Treatment of Cancer-Quality of Life (EORTC QLQ-C30) Dyspnea Score Between Baseline and Day 7
timeFrame: Baseline and Day 7
measure: Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Unpleasantness
timeFrame: Baseline and Day 14
measure: Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 14
timeFrame: Baseline and Day 14
measure: Change in European Organization for Research and Treatment of Cancer Quality of Life (EORTC) Dyspnea Score Between Baseline and Day 14
timeFrame: Baseline and Day 14
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon B. Johnson Hospital
state: Texas
city: Houston
country: United States
facility: Harris Health System Settegast Health Center
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David Hui
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.