Dexamethasone Dyspnea Study

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT01670097
Collaborator
(none)
52
1
2
96.8
0.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexamethasone
  • Drug: Placebo
  • Behavioral: Questionnaires
  • Device: Spirometer
  • Other: Phone Calls
Phase 2

Detailed Description

Baseline Tests:

If you are found to be eligible to take part in this study, you will have baseline tests after completing the screening questionnaires. The following tests and procedures will be performed:

  • Information will be collected from your medical record about your age, sex, race, disease type, how well you are able to perform the normal activities of daily living, any drugs you are taking, and possible causes of shortness of breath.

  • Your breathing rate will be measured.

  • The amount of oxygen in your body will be measured using a machine that clips on your finger.

  • You will blow into a device called a spirometer a few times to measure your lung function.

  • You will be asked to answer 4 questionnaires. The first questionnaire asks you to rate your level of symptoms, such as pain, tiredness, sleep, appetite, depression, anxiety, and drowsiness. The second questionnaire asks about your sensation of breathing. The third questionnaire asks you to rate the intensity of your shortness of breath. The last questionnaire asks about your quality of life. These questionnaires should take a total of about 40 minutes to complete.

Study Groups:
You will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups:
  • If you are in Group 1, you will receive dexamethasone.

  • If you are in Group 2, you will receive a placebo for 7 days, then dexamethasone for 7 days.

You will have an equal chance of being assigned to either group. Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.

Study Drug/Placebo Administration:

After your baseline tests, you will be given a supply of either the study drug or the placebo to bring home.

Starting the next morning, you will take 2 dexamethasone or placebo capsules twice a day by mouth for 4 days. Then, you will take 1 tablet twice a day for 3 more days.

After the first 7 days, no matter which group you have been assigned to, you will only take 1 dexamethasone capsule twice a day for 7 more days

You should take the capsules around 8 o'clock in the morning and 4 o'clock in the afternoon. You should take the capsules with food and 8 ounces of water.

You will also receive a portable spirometer to test your lung function. You should blow into the machine 1 time a day.

Study Visits/Calls:

On Days 7 and 14, you will return to the clinic or be called by phone. You should bring your capsule boxes with you if you come to the clinic, or have them with you if you are called so the study staff can count the number of capsules. The following tests and procedures will be performed:

  • You will be asked to complete the same 4 questionnaires you completed during your baseline tests.

  • You will also be asked about any side effects you may be having and if you think the study drug is helping your shortness of breath.

  • You will blow into a spirometer to measure your lung function.

During the 14 days you will be taking either the study drug or the placebo on the study, you will be called by phone 1 time each day to ask you about your level of shortness of breath and to remind you to take the capsules. These calls should last about 5 minutes.

Length of Study:

You may continue taking the study drug for up to 14 days, as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if intolerable side effects occur or if you are unable to follow study directions.

Your participation on the study will be over when you have completed the follow-up calls and visit.

This is an investigational study. Dexamethasone is FDA approved and commercially available for the treatment of pain, nausea and tiredness. Its use to help control shortness of breath is investigational.

Up to 40 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Study Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Preliminary Study of Dexamethasone for Dyspnea in Cancer Patients
Actual Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Aug 1, 2020
Actual Study Completion Date :
Jan 26, 2021

Arms and Interventions

Arm Intervention/Treatment
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. Participants randomized to either dexamethasone or placebo for 7 days in a blinded fashion; this will be followed by an open label phase in which patients in both arms would take dexamethasone for 7 days.

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 Names:
  • Decadron
  • Behavioral: Questionnaires
    Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.
    Other Names:
  • 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. Participants randomized to either dexamethasone or placebo for 7 days in a blinded fashion; this will be followed by an open label phase in which patients in both arms would take dexamethasone for 7 days.

    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 Names:
  • Decadron
  • 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 Names:
  • 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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Who Completed the Dyspnea Numeric Rating Scale [Baseline to Day 7]

      Number of participants who completed the dyspnea numeric rating scale on Day 7

    Secondary Outcome Measures

    1. Edmonton Symptom Assessment System Dyspnea Score [Baseline to Day 4, Day 7, Day 14]

      The Secondary outcome is the Edmonton Symptom Assessment System dyspnea intensity which is measured with a single 11-point numeric rating score that ranges between 0 and 10, with 0 being no symptom at all and 10 being worst possible. We measured the change in Edmonton Symptom Assessment System dyspnea numeric rating score (average 24 h) form baseline to Day 4, Day 7 and Day 14.

    2. Dyspnea Numeric Rating Score (Now) [Baseline to day 4, Day 7 and Day 14]

      Secondary outcome was dyspnea intensity 'now' using a dyspnea numeric rating scale that ranges from 0 (no shortness of breath) to 10 (worst possible shortness of breath). We measured the change in Dyspnea numeric rating score form baseline to Day 4, Day 7 and Day 14.

    3. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea [Baseline to day 4, Day 7 and Day 14.]

      European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, consists of 30 items that encompasses three symptom scales (pain, fatigue, nausea/vomiting), six single-item symptom items, five functional scales (physical, cognitive, role, emotional, and social), and one scale assessing global health status/quality of life. Each scale comprises 2-5 items. All items have four response categories (1=not at all, 2=a little, 3=quite a bit, 4=very much), except for two items assessing overall health status/quality of life, which use a seven-point scale. This questionnaire includes one item to assess dyspnea during the past week ("Were you short of breath?). The four-point ordinal scale was transformed to 0-100 points using a formula, higher scores indicate worse dyspnea. We measured the change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea score form baseline to Day 4, Day 7 and Day 14.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Texas MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: David Hui, MD, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT01670097
    Other Study ID Numbers:
    • 2012-0001
    • NCI-2012-01615
    First Posted:
    Aug 21, 2012
    Last Update Posted:
    Feb 17, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by M.D. Anderson Cancer Center
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Adult cancer patient with lung involvement were recruited between 1/2013 and 5/2015 from the Supportive Care Center outpatient clinic of MD Anderson Cancer Center who satisfied the inclusion and exclusion criteria.
    Pre-assignment Detail A total of 52 participants enrolled for this study. Among them, 41 patients were randomized. 6 participants declined to continue and 5 participants became ineligible (3 started steroids, 2 had other reasons) before randomization, thus a total of 11 participants were dropped out before randomization.
    Arm/Group Title Intervention Group (Dexamethasone) Controlled Group (Placebo)
    Arm/Group Description Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days. Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
    Period Title: Overall Study
    STARTED 20 21
    Completed Week 1 Intervention 18 17
    Completed Week 2 Intervention 13 15
    COMPLETED 18 17
    NOT COMPLETED 2 4

    Baseline Characteristics

    Arm/Group Title Intervention Group (Dexamethasone) Controlled Group (Placebo) Total
    Arm/Group Description Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days. Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days. Total of all reporting groups
    Overall Participants 20 21 41
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    62
    64
    63
    Sex: Female, Male (Count of Participants)
    Female
    11
    55%
    14
    66.7%
    25
    61%
    Male
    9
    45%
    7
    33.3%
    16
    39%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    1
    5%
    1
    4.8%
    2
    4.9%
    Not Hispanic or Latino
    19
    95%
    20
    95.2%
    39
    95.1%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    1
    4.8%
    1
    2.4%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    5
    25%
    6
    28.6%
    11
    26.8%
    White
    15
    75%
    14
    66.7%
    29
    70.7%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    20
    100%
    21
    100%
    41
    100%
    Education (Count of Participants)
    High School or less
    16
    80%
    18
    85.7%
    34
    82.9%
    College and above
    4
    20%
    3
    14.3%
    7
    17.1%
    Cancer Type (Count of Participants)
    Mesothelioma
    1
    5%
    3
    14.3%
    4
    9.8%
    Non-small cell lung cancer
    14
    70%
    17
    81%
    31
    75.6%
    Small cell lung cancer
    2
    10%
    0
    0%
    2
    4.9%
    Other
    3
    15%
    1
    4.8%
    4
    9.8%
    Cancer Stage (Count of Participants)
    Localized
    4
    20%
    1
    4.8%
    5
    12.2%
    Locally advanced
    3
    15%
    4
    19%
    7
    17.1%
    Metastatic/recurrent
    13
    65%
    16
    76.2%
    29
    70.7%
    Comorbidities (Count of Participants)
    COPD
    2
    10%
    7
    33.3%
    9
    22%
    Asthma
    1
    5%
    2
    9.5%
    3
    7.3%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants Who Completed the Dyspnea Numeric Rating Scale
    Description Number of participants who completed the dyspnea numeric rating scale on Day 7
    Time Frame Baseline to Day 7

    Outcome Measure Data

    Analysis Population Description
    Baseline Analysis included all randomized participants, 20 participants in intervention arm and 21 participants in control arm
    Arm/Group Title Intervention Group (Dexamethasone) Controlled Group (Placebo)
    Arm/Group Description Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days. Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
    Measure Participants 20 21
    Count of Participants [Participants]
    18
    90%
    17
    81%
    2. Secondary Outcome
    Title Edmonton Symptom Assessment System Dyspnea Score
    Description The Secondary outcome is the Edmonton Symptom Assessment System dyspnea intensity which is measured with a single 11-point numeric rating score that ranges between 0 and 10, with 0 being no symptom at all and 10 being worst possible. We measured the change in Edmonton Symptom Assessment System dyspnea numeric rating score (average 24 h) form baseline to Day 4, Day 7 and Day 14.
    Time Frame Baseline to Day 4, Day 7, Day 14

    Outcome Measure Data

    Analysis Population Description
    The number of participants varied by milestone study days (Baseline (38 participants) , Day 4 (30 participants) , Day 7 (30 participants) and Day 14 (28 participants) who completed the Edmonton Symptom Assessment Questionnaire.
    Arm/Group Title Intervention Group (Dexamethasone) Controlled Group (Placebo)
    Arm/Group Description Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days. Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
    Measure Participants 19 19
    Day 4
    -1.9
    -0.7
    Day 7
    -1.8
    -1.3
    Day 14
    -2.1
    -1.7
    3. Secondary Outcome
    Title Dyspnea Numeric Rating Score (Now)
    Description Secondary outcome was dyspnea intensity 'now' using a dyspnea numeric rating scale that ranges from 0 (no shortness of breath) to 10 (worst possible shortness of breath). We measured the change in Dyspnea numeric rating score form baseline to Day 4, Day 7 and Day 14.
    Time Frame Baseline to day 4, Day 7 and Day 14

    Outcome Measure Data

    Analysis Population Description
    The number of participants varied by milestone study days (Baseline (38 participants), Day 4, (35 participants) Day 7 (35 participants), and Day 14 (26 participants) who completed the Dyspnea Numeric Rating Score Questionnaire.
    Arm/Group Title Intervention Group (Dexamethasone) Controlled Group (Placebo)
    Arm/Group Description Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days. Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
    Measure Participants 19 19
    Day 4
    0
    -0.1
    Day 7
    -1.1
    -0.2
    Day 14
    -1.6
    -1.5
    4. Secondary Outcome
    Title European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea
    Description European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, consists of 30 items that encompasses three symptom scales (pain, fatigue, nausea/vomiting), six single-item symptom items, five functional scales (physical, cognitive, role, emotional, and social), and one scale assessing global health status/quality of life. Each scale comprises 2-5 items. All items have four response categories (1=not at all, 2=a little, 3=quite a bit, 4=very much), except for two items assessing overall health status/quality of life, which use a seven-point scale. This questionnaire includes one item to assess dyspnea during the past week ("Were you short of breath?). The four-point ordinal scale was transformed to 0-100 points using a formula, higher scores indicate worse dyspnea. We measured the change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea score form baseline to Day 4, Day 7 and Day 14.
    Time Frame Baseline to day 4, Day 7 and Day 14.

    Outcome Measure Data

    Analysis Population Description
    The number of participants varied by milestone study days (Baseline (38 participants), Day 4 (30 participants), Day 7 (29 participants), and Day 14 (28 participants) who completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-20 Dyspnea.
    Arm/Group Title Intervention Group (Dexamethasone) Controlled Group (Placebo)
    Arm/Group Description Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days. Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
    Measure Participants 19 19
    Day 4
    -15.6
    0
    Day 7
    -10.4
    -5.1
    Day 14
    -7.7
    -6.7

    Adverse Events

    Time Frame Baseline to Day 4, Day 7, and Day 14.
    Adverse Event Reporting Description As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
    Arm/Group Title Intervention Group (Dexamethasone) Controlled Group (Placebo)
    Arm/Group Description Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days. Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
    All Cause Mortality
    Intervention Group (Dexamethasone) Controlled Group (Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/20 (0%) 0/21 (0%)
    Serious Adverse Events
    Intervention Group (Dexamethasone) Controlled Group (Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/20 (0%) 0/21 (0%)
    Other (Not Including Serious) Adverse Events
    Intervention Group (Dexamethasone) Controlled Group (Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/20 (15%) 5/21 (23.8%)
    Gastrointestinal disorders
    Diarrhea 1/20 (5%) 0/21 (0%)
    Dyspepsia 1/20 (5%) 2/21 (9.5%)
    Halitosis 1/20 (5%) 0/21 (0%)
    Hyperglycemia 1/20 (5%) 1/21 (4.8%)
    Mouth sores 0/20 (0%) 1/21 (4.8%)
    Taste changes 0/20 (0%) 1/21 (4.8%)
    Nausea/vomiting 0/20 (0%) 4/21 (19%)
    Gastric Hemorrhage 0/20 (0%) 2/21 (9.5%)
    General disorders
    Edema 3/20 (15%) 1/21 (4.8%)
    Insomnia 2/20 (10%) 5/21 (23.8%)
    Fatigue 0/20 (0%) 3/21 (14.3%)
    Fever 0/20 (0%) 1/21 (4.8%)
    Musculoskeletal and connective tissue disorders
    Myalgia 1/20 (5%) 1/21 (4.8%)
    Nervous system disorders
    Anxiety/Irritability 2/20 (10%) 0/21 (0%)
    Hiccup 1/20 (5%) 0/21 (0%)
    Hot flash 1/20 (5%) 0/21 (0%)
    Hyperhidrosis 1/20 (5%) 0/21 (0%)
    Blurred vision 0/20 (0%) 2/21 (9.5%)
    Flasing 0/20 (0%) 1/21 (4.8%)
    Pain 0/20 (0%) 2/21 (9.5%)
    Respiratory, thoracic and mediastinal disorders
    Sore throat 0/20 (0%) 1/21 (4.8%)
    Skin and subcutaneous tissue disorders
    Rash 0/20 (0%) 1/21 (4.8%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title David Hui, MD/ Associate Professor, Palliative Care Medicine
    Organization UT MD Anderson Cancer Center
    Phone (713) 792-6258
    Email dhui@mdanderson.org
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT01670097
    Other Study ID Numbers:
    • 2012-0001
    • NCI-2012-01615
    First Posted:
    Aug 21, 2012
    Last Update Posted:
    Feb 17, 2021
    Last Verified:
    Jan 1, 2021