Dexamethasone in Controlling Dyspnea in Patients With Cancer

M.D. Anderson Cancer Center

Status and phase

Active, not recruiting

Phase 2

Conditions

Malignant Neoplasm

Dyspnea

Treatments

Other: Placebo

Drug: Dexamethasone

Other: Questionnaire Administration

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03367156

2017-0591 (Other Identifier)

NCI-2018-01129 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

135 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.