Dexamethasone in Controlling Dyspnea in Patients With Cancer
Condition: Dyspnea; Malignant Neoplasm
MeSH terms: Neoplasms; Dyspnea
Intervention: Dexamethasone; Placebo; Questionnaire Administration
Intervention description: Given PO; Given PO; Ancillary studies
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Ichthammol; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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.