Dexamethasone Dyspnea Study
Condition: Advanced Cancers; Hematologic Disorder; Solid Tumors
MeSH terms: Dyspnea; Hematologic Diseases
Intervention: Dexamethasone; Placebo; Questionnaires; Spirometer; Phone Calls
Intervention description: Group 1 Blinded Phase: 8 mg (2 capsules of 4 mg) given orally twice a day for 4 days, then 4 mg given orally twice a day for 3 days.
Open Label Phase Groups 1 and 2: 4 mg by mouth twice a day for 7 days.; Group 2 Blinded Phase: Two capsules by mouth twice a day for 4 days, followed by one capsule twice a day for 3 days.; Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.; Patient to blow into spirometry machine 1 time a day to test lung function.; Patient called by phone 1 time each day to ask about level of shortness of breath and to remind patient to take capsules. These calls should last about 5 minutes.
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Cancers; Hematologic Disorder; Solid Tumors; Dyspnea; Difficulty breathing; Shortness of breath; Dexamethasone; Decadron; Placebo; Sugar pill; Questionnaires; Surveys; Spirometer; Phone calls

Summary:

      The goal of this clinical research study is to learn if dexamethasone can help reduce
      shortness of breath in cancer patients. Researchers also want to learn if it can help to
      improve lung function and quality of life. In this study, dexamethasone will be compared to a
      placebo.

      Dexamethasone is commonly used for treatment of nausea, tiredness, and pain. It may help
      patients with shortness of breath.

      A placebo is not a drug. It looks like the study drug but is not designed to treat any
      disease or illness. It is designed to be compared with a study drug to learn if the study
      drug has any real effect.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of cancer

          2. Dyspnea with an average intensity level >3/10 on the numeric rating scale over the
             past week

          3. Clinical or radiologic history of lung/pleural involvement (primary or metastatic),
             lymphangitic carcinomatosis or airway involvement secondary to tumor infiltration

          4. Outpatients at MD Anderson Cancer Center seen by the Supportive Care, Rehabilitation
             Service, Thoracic Oncology or Pulmonary Medicine

          5. Able to communicate in English

          6. Karnofsky performance status >=40%

          7. Age 18 or older

          8. Permission from the attending medical oncologist if the patient is currently on an
             interventional cancer therapy trial.

        Exclusion Criteria:

          1. Delirium (i.e. Memorial delirium rating scale >13)

          2. Oxygen saturation <90% despite supplemental oxygen >6L/min

          3. Previous allergic reactions to dexamethasone

          4. Uncontrolled hyperglycemia as defined by any blood glucose of >300 mg/dl in the past
             two weeks

          5. Severe anemia (Hb <7g/L) not corrected prior to study enrollment (bloodwork is not
             required if patient did not have recent chemotherapy within last 2 weeks)

          6. Post-surgical open wound that has not been healed at the time of enrollment

          7. Any infection requiring parenteral antibiotics within the past 2 weeks

          8. Major surgery within the past 2 weeks

          9. Megestrol use at the time of study enrollment

         10. Neutropenia (absolute neutrophil count < 1.0) (bloodwork is not required if patient
             did not have recent chemotherapy within last 2 weeks)

         11. Currently on or expected to start cytotoxic chemotherapy with in 1 week of study
             enrollment

         12. Chronic obstructive pulmonary disease (COPD) exacerbation at the time of study
             enrollment

         13. Heart failure exacerbation at the time of study enrollment

         14. Chronic systemic corticosteroid use (>14 days) at the time of study enrollment

         15. Unwilling to provide informed consent