- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02491632
Physical Activity and Dexamethasone in Reducing Cancer-Related Fatigue in Patients With Advanced Cancer
Effects of Physical Activity Plus Short Course of Dexamethasone for Cancer-Related Fatigue in Advanced Cancer
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
1. To determine the feasibility, adherence, and satisfaction with physical activity (PA) plus dexamethasone (PA+ DEX).
SECONDARY OBJECTIVES:
I. 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.
II. 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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
Correlative studies
Ancillary studies
Other Names:
Ancillary studies
Given PO
Other Names:
Complete a graded resistance exercise program and a walking regimen
|
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.
|
Correlative studies
Ancillary studies
Other Names:
Ancillary studies
Given PO
Other Names:
Complete a graded resistance exercise program and a walking regimen
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Levels at Day 8 and Day 29
Time Frame: Baseline, day 8, day 29
|
FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) subscale is a 13 item subscale of FACT-G that allows patient to rate the intensity of their fatigue and its related symptoms on a scale of 0 (not at all) to 4 (very much).
The total calculated score varied from 0-52 with a lower score indicating a more severe fatigue level.
We measured the change in FACIT-F levels between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test.
|
Baseline, day 8, day 29
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Patient Reported Outcome Measurement Information System-Fatigue (PROMIS-F) Total
Time Frame: Baseline, day 8, day 29
|
The PROMIS-F (Patient Reported Outcome Measurement Information System-Fatigue) short form was used to measure the experience of fatigue in patients' daily activities over the past week.
It consists of 7 items with response options on a 5-point Likert scale, ranging from 1 (never) to 5 (always).
We measured the change in PROMIS-F score between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test.
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.
|
Baseline, day 8, day 29
|
Change in Edmonton Symptom Assessment Scale (ESAS) Fatigue
Time Frame: Baseline, day 8, day 29
|
ESAS (Edmonton Symptom Assessment Scale) is a validated scale ranging from 0 (not at all) to 10 (very much) used to assess 10 symptoms commonly experienced by cancer patients during the previous 24 hours: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep and feeling of wellbeing.
We measured the change in ESAS fatigue score between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test.
Total ESAS fatigue score ranges from 0-10, with a higher score indicating higher fatigue.
|
Baseline, day 8, day 29
|
Change in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI_SF) Total Score
Time Frame: Baseline, day 8, day 29
|
The MFSI-SF is a 30-item scale used to assess the multidimensional nature of fatigue.
Responses are selected using a 5-point scale, ranging from 0 (not at all) to 4 (extremely fatigue).
It consists of 5 subscales: general fatigue, physical fatigue, emotional fatigue, mental fatigue and vigor.
The MFSI-SF total score is the sum of the general fatigue, physical fatigue, emotional fatigue and mental fatigue subscale score and subtracting vigor subscale score.
Thus MFSI-SF total score ranges from 24-96, with a higher score indicating a higher fatigue level.
We measured the change in MFSI-SF total score between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test.
|
Baseline, day 8, day 29
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sriram Yennu, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Neoplasms
- Fatigue
- Recurrence
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Dermatologic Agents
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Ichthammol
Other Study ID Numbers
- 2014-0436 (Other Identifier: M D Anderson Cancer Center)
- NCI-2015-01320 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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