Physical Activity and Dexamethasone in Reducing Cancer-Related Fatigue in Patients With Advanced Cancer

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02491632
Collaborator
National Cancer Institute (NCI) (NIH)
87
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2
88.6
1

Study Details

Study Description

Brief Summary

This randomized phase II trial studies how well physical activity and dexamethasone work in reducing cancer-related fatigue in patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Dexamethasone is approved for the treatment of tiredness, pain, and nausea. Physical activity may help improve cancer-related fatigue by improvement in symptoms, distress, and overall well-being. It is not yet known whether high dose or low dose dexamethasone combined with physical activity works better in reducing fatigue in patients with advanced cancer.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexamethasone
  • Behavioral: Exercise Intervention
  • Other: Laboratory Biomarker Analysis
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
Phase 2/Phase 3

Detailed Description

PRIMARY OBJECTIVES:
  1. To determine the feasibility, adherence, and satisfaction with physical activity (PA) plus dexamethasone (PA+ DEX).
SECONDARY OBJECTIVES:
  1. To explore the preliminary efficacy of PA+ Hi Dex group (PA for 4 weeks plus high dose dexamethasone for 1 week) and PA + Lo Dex groups (PA for 4 weeks plus low dose dexamethasone for 1 week) on cancer-related fatigue (CRF) as measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at the end of one week.

  2. To explore the effects of PA+ Hi Dex on the various dimensions of CRF (Patient-Reported Outcomes Measurement Information System-Fatigue [PROMIS-F]), i.e., affective/emotional (Hospital Anxiety Depression Scale [HADS]); physical/behavioral (the Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], Pittsburg Sleep Quality Index), physical activity and function (30 second sit-to stand test, six minute walk test) before and after treatment.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive high-dose dexamethasone orally (PO) twice daily (BID) for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.

ARM II: Patients receive low-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.

After completion of study, patients are followed up at day 29 and again after 1 month.

Study Design

Study Type:
Interventional
Actual Enrollment :
87 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Effects of Physical Activity Plus Short Course of Dexamethasone for Cancer-Related Fatigue in Advanced Cancer
Actual Study Start Date :
Aug 13, 2015
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (high-dose dexamethasone, physical activity)

Patients receive high-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.

Drug: Dexamethasone
Given PO
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone
  • Behavioral: Exercise Intervention
    Complete a graded resistance exercise program and a walking regimen

    Other: Laboratory Biomarker Analysis
    Correlative studies

    Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Experimental: Arm II (low dose dexamethasone, physical activity)

    Patients receive low-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.

    Drug: Dexamethasone
    Given PO
    Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone
  • Behavioral: Exercise Intervention
    Complete a graded resistance exercise program and a walking regimen

    Other: Laboratory Biomarker Analysis
    Correlative studies

    Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility of dexamethasone combined with exercise, as evidenced by adherence rate to daily use of physical activity and dexamethasone >= 75% [Up to 4 weeks]

      95% confidence intervals will be estimated for the proportion of patients completing the intervention.

    2. Adherence of dexamethasone combined with exercise [Up to 4 weeks]

      Adherence to walking exercise is defined as either at least 90 minutes every week or at least 360 minutes in 4 weeks. Adherence to resistance exercise is defined as either at least 2 completions of exercises every week or at least 7 completions of exercises in 4 weeks.

    3. Satisfaction with dexamethasone combined with exercise: proportion of patients with a satisfaction rating >= 8 [Up to 2 months after the last day of physical activity]

      95% confidence intervals will be estimated for the proportion of patients with a satisfaction rating >= 8.

    Secondary Outcome Measures

    1. Change in the Functional Assessment of Chronic Illness Therapy-Fatigue subscale score [Baseline to 8 days]

      Measured by Functional Assessment of Cancer Illness Therapy-Fatigue (FACIT-F) subscale, a well-validated quality of life instrument. The 13-item fatigue subscale is a patient-rated assessment of intensity of fatigue and its related symptoms on a scale of 0 to 4. This scale has been shown to have strong internal consistency (α = 0.93-0.95), sensitivity of 0.92, and specificity of 0.6923.

    Other Outcome Measures

    1. Change in Multidimensional Fatigue Symptom Inventory-Short Form scores [Baseline up to 2 months after the last day of physical activity]

      Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) consists of 30 items designed to assess the multidimensional nature of fatigue. Ratings are summed to obtain scores for 5 subscales (general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor) Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) 0-4 (Not at all 0, A little 1, Moderately, Quite a bit 3, Extremely 4)

    2. Change in Patient-Reported Outcomes Measurement Information System-Fatigue scores [Baseline up to 2 months after the last day of physical activity]

      Patient-Reported Outcomes Measurement Information System (PROMIS F-SF) consists of seven items that measure both the experience of fatigue and the interference of fatigue on daily activities over the past week Examples of items are: "How often did you feel tired," and "How often were you too tired to take a bath/shower". Response options are on a 5-point Likert scale, ranging from 1 = never to 5 =always. One item, "How often did you have enough energy to exercise strenuously," is reverse scored. The total score is used in the analysis and is obtained by summing keyed scores of all items. Scores can range from 7 to 35, with higher scores indicating greater fatigue.

    3. Change in Hospital Anxiety Depression Scale scores [Baseline up to 2 months after the last day of physical activity]

      Hospital Anxiety and Depression Scale (HADS), a 14-item questionnaire has been validated in a number of clinical situations and has been widely used in medically ill patients. Scores from 0 to 3 for a total score of 0 to 21

    4. Change in cytokine levels [Baseline up to 2 months after the last day of physical activity]

      Estimated with 95% confidence intervals. Standard descriptive statistics, including means, standard deviations, ranges, and frequencies, will be computed where appropriate. Distributional characteristics of relevant variables will also be closely examined with use of box plots and histograms. If the data do not appear to be approximately normally distributed, transformations will be made to the data, or appropriate nonparametric methods will be used.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • A diagnosis of advanced cancer (defined as metastatic or recurrent) with fatigue >= 4/10 (0-10 scale) on the Edmonton Symptom Assessment Scale (ESAS)

    • The presence of fatigue for at least 2 weeks

    • Normal cognition

    • Hemoglobin > 8 g/L within 1 week of enrollment in the study

    • A life expectancy of >= 4 months

    • No evidence of significant anxiety or depression as determined by a total HADS scores of < 21

    • Definition of advanced cancer includes those patients who have metastatic or refractory disease according to their treating oncologist

    • Patients must be able to understand, read, write, and speak English or Spanish

    Exclusion Criteria:
    • Patients with a history of hypersensitivity to dexamethasone or having any contraindication to physical activity as determined by the treating physician

    • Reports a fall in the past 30 days

    • Uncontrolled diabetes mellitus as defined by a random blood sugar of > 200 mg/dl not being monitored by their primary care physician

    • Sepsis and/or acute, chronic, or ongoing infections that are currently being treated with systemic antimicrobials

    • Will exclude patients with current, active peptic ulcer disease

    • Neutropenia as defined by an absolute neutrophil count (ANC) of < 1000 cells/mm

    • Regular participation in moderate- or vigorous-intensity physical activity for >= 30 minutes at least 5 times a week and strength training for >= 2 days

    • Severe cardiac disease (New York Heart Association functional class III or IV) or coronary artery disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Sriram Yennu, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02491632
    Other Study ID Numbers:
    • 2014-0436
    • NCI-2015-01320
    • 2014-0436
    First Posted:
    Jul 8, 2015
    Last Update Posted:
    Mar 18, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 18, 2022