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Clinical Trial NCT02491632 for Advanced Malignant Neoplasm, Fatigue, Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm, Refractory Malignant Neoplasm is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Physical Activity and Dexamethasone in Reducing Cancer-Related Fatigue in Patients With Advanced Cancer

Active, not recruiting
Clinical Trial NCT02491632 is designed to study Supportive Care for Advanced Malignant Neoplasm, Fatigue, Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm, Refractory Malignant Neoplasm. It is a Phase 2 Phase 3 interventional trial that is active, not recruiting, having started on 13 August 2015, with plans to enroll 90 participants. Led by M.D. Anderson Cancer Center, it is expected to complete by 31 December 2026. The latest data from ClinicalTrials.gov was last updated on 28 October 2025.
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.
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.

Official Title

Effects of Physical Activity Plus Short Course of Dexamethasone for Cancer-Related Fatigue in Advanced Cancer

Conditions
Advanced Malignant NeoplasmFatigueMetastatic Malignant NeoplasmRecurrent Malignant NeoplasmRefractory Malignant Neoplasm
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
NCT ID Number
NCT02491632
Start Date (Actual)
2015-08-13
Last Update Posted
2025-10-28
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
90
Study Type
Interventional
PHASE
Phase 2
Phase 3
Status
Active, not recruiting
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalArm 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.
Dexamethasone
Given PO
Exercise Intervention
Complete a graded resistance exercise program and a walking regimen
Laboratory Biomarker Analysis
Correlative studies
Quality-of-life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
ExperimentalArm 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.
Dexamethasone
Given PO
Exercise Intervention
Complete a graded resistance exercise program and a walking regimen
Laboratory Biomarker Analysis
Correlative studies
Quality-of-life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Levels at Day 8 and 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 MeasureMeasure DescriptionTime Frame
Change in Patient Reported Outcome Measurement Information System-Fatigue (PROMIS-F) Total
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
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
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
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
M.D. Anderson Cancer Center logoM.D. Anderson Cancer Center1128 active trials to explore
National Cancer Institute (NCI) logoNational Cancer Institute (NCI)3028 active trials to explore
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1 Study Locations in 1 Countries

Texas

M D Anderson Cancer Center, Houston, Texas, 77030, United States