Dexamethasone Dyspnea Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01670097
First received: August 17, 2012
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Advanced Cancers
Hematologic Disorder
Solid Tumors
Drug: Dexamethasone
Drug: Placebo
Behavioral: Questionnaires
Device: Spirometer
Other: Phone Calls
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Preliminary Study of Dexamethasone for Dyspnea in Cancer Patients

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Completion Rate of Dyspnea Numeric Rating Scale (NRS) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Primary objective is to determine completion rate for patients enrolling in this study. Patients who complete dyspnea NRS on day 7 +/- 2 counted as successes. Dropouts defined as subjects who do not complete the dyspnea NRS on day 7 +/- 2, and counted as failures toward the feasibility outcome.


Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexamethasone
Dexamethasone 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. In the open label phase, patients assigned to either arm asked to take Dexamethasone 4 mg orally twice a day for 7 days. Patient to blow into spirometry machine 1 time a day to test lung function. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.
Drug: Dexamethasone

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.

Other Name: Decadron
Behavioral: Questionnaires
Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.
Other Name: Surveys
Device: Spirometer
Patient to blow into spirometry machine 1 time a day to test lung function.
Other: Phone Calls
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.
Placebo Comparator: Placebo
Two placebo capsules taken twice a day for 4 days, followed by one capsule twice a day for 3 days. Patient to blow into spirometry machine 1 time a day to test lung function. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.
Drug: Placebo
Group 2 Blinded Phase: Two capsules by mouth twice a day for 4 days, followed by one capsule twice a day for 3 days.
Other Name: Sugar pill
Behavioral: Questionnaires
Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.
Other Name: Surveys
Device: Spirometer
Patient to blow into spirometry machine 1 time a day to test lung function.
Other: Phone Calls
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670097

Contacts
Contact: David Hui, MD 713-792-6258

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: David Hui, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01670097     History of Changes
Other Study ID Numbers: 2012-0001, NCI-2012-01615
Study First Received: August 17, 2012
Last Updated: May 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancers
Hematologic Disorder
Solid Tumors
Dyspnea
Difficulty breathing
Shortness of breath
Dexamethasone
Decadron
Placebo
Sugar pill
Questionnaires
Surveys
Spirometer
Phone calls

Additional relevant MeSH terms:
Dyspnea
Hematologic Diseases
Neoplasms
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014