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Trial Radar IA
Lo studio clinico NCT02491632 per Neoplasia maligna avanzata, Affaticamento, Neoplasia Maligna Metastatica, Neoplasia Maligna Ricorrente, Neoplasia Maligna Refrattaria è attivo, non in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Physical Activity and Dexamethasone in Reducing Cancer-Related Fatigue in Patients With Advanced Cancer

Attivo, non in arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT02491632 è uno studio interventistico di Fase II Fase III volto a esaminare la terapia di supporto per Neoplasia maligna avanzata, Affaticamento, Neoplasia Maligna Metastatica, Neoplasia Maligna Ricorrente, Neoplasia Maligna Refrattaria, attualmente attivo, non in arruolamento. Avviato il 13 agosto 2015, prevede di arruolare 90 partecipanti. Sotto la guida di il Centro medico MD Anderson, dovrebbe concludersi entro il 31 dicembre 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 28 ottobre 2025.
Sommario breve
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.
Descrizione dettagliata
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.

Titolo ufficiale

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

Condizioni
Neoplasia maligna avanzataAffaticamentoNeoplasia Maligna MetastaticaNeoplasia Maligna RicorrenteNeoplasia Maligna Refrattaria
Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:
Altri ID dello studio
Numero NCT
NCT02491632
Data di inizio (effettiva)
2015-08-13
Ultimo aggiornamento pubblicato
2025-10-28
Data di completamento (stimata)
2026-12-31
Arruolamento (previsto)
90
Tipo di studio
Interventistico
FASE
Fase II
Fase III
Stato
Attivo, non in arruolamento
Scopo principale
Terapia di supporto
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Doppio
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleArm 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
Intervento di esercizio
Complete a graded resistance exercise program and a walking regimen
Analisi dei biomarcatori di laboratorio
Correlative studies
Valutazione della qualità della vita
Ancillary studies
Somministrazione del questionario
Ancillary studies
SperimentaleArm 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
Intervento di esercizio
Complete a graded resistance exercise program and a walking regimen
Analisi dei biomarcatori di laboratorio
Correlative studies
Valutazione della qualità della vita
Ancillary studies
Somministrazione del questionario
Ancillary studies
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  • 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 logoCentro medico MD Anderson1128 studi clinici attivi da esplorare
National Cancer Institute (NCI) logoIstituto nazionale dei tumori, Estados Unidos3028 studi clinici attivi da esplorare
Nessun dato di contatto
1 Centri dello studio in 1 paesi

Texas

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