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Efficacy of Massage for the Treatment of Cancer-Related Fatigue (CRF) in Prostate Cancer Survivors (mProstate)

4 giugno 2019 aggiornato da: Mark H. Rapaport, Emory University

Cancer-related fatigue (CRF) is a prevalent and debilitating symptom experienced by cancer survivors. CRF can persist for months or years after cancer therapy is completed and has a negative impact on all areas of mental and physical function. Treatment options for CRF are extremely limited and finding safe, inexpensive, and effective interventions for managing this distressing symptom are urgently needed. Massage therapy is one of the fastest growing complementary therapies. A recently completed study in breast cancer survivors with CRF found that Swedish Massage Therapy (SMT) caused a significant reduction in fatigue and improvement in quality of life. This study investigates the effects of massage therapy on CRF among prostate cancer survivors. The study will evaluate whether SMT improves quality of life, depression, and anxiety. Second, this study will evaluate if SMT reduces CRF by decreasing the pro-inflammatory cytokine Interleukin-6 (IL-6). Lastly, to establish measures of reduced fatigue beyond self report at the treatment visits, the researchers will implement continuous, real-time monitoring of physiologic and psychological signs and symptoms, throughout the treatment period. This study will improve care for CRF and other hard-to-manage symptoms of cancer treatment and provide preliminary evidence of immune modulation as a potential mechanism of action.

This study is a randomized clinical trial to test the efficacy of Swedish massage therapy (SMT) versus an active control condition (light touch, LT) on cancer related fatigue in men with prostatic cancer, at least 2 months after the end of their radiation therapy. The primary outcome is the Multidimensional Fatigue Inventory (MFI). Secondary outcomes are the Patient-Reported Outcomes Measurement System (PROMIS) Fatigue Scale, plasma concentrations of cytokine IL-6, self-reported quality of life, depression, and anxiety, wearable measures of activity and sleep, and Automated Monitoring of Symptom Severity (AMoSS) ratings.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Fatigue is the most common, and one of the most devastating symptoms among patients with cancer. According to the National Comprehensive Cancer Network (NCCN), cancer-related fatigue (CRF) is "a distressing, persistent, subjective sense of physical, emotional, and/or cognitive exhaustion related to cancer or its treatment that is not proportional to recent activity". Fatigue occurs across the spectrum of cancer types and treatments. CRF has a negative impact on all areas of function, including mood, physical function, work performance, social interaction, family care, cognitive performance, schoolwork, and community activities. CRF has been rated as more troublesome and to have a greater negative impact on quality of life than other cancer-related symptoms such as pain, depression, and nausea. CRF can persist for months or years after cancer therapy is completed.

Meaningful, evidence-based treatment options for CRF are limited. Over 50% of patients with cancer have used a complementary and alternative medicine (CAM) approach for symptom management and quality of life. One of the widely employed CAM interventions is massage therapy. Most of the studies investigating massage for patients with cancer focus on depression, anxiety, or pain as the outcomes of interest. A previous investigation of breast cancer survivors reported decreases in mood symptoms and an improvement in fatigue, however, CRF was not the primary outcome measure. This randomized clinical trial will test the efficacy of Swedish massage therapy (SMT) vs. an active control condition (light touch, LT) on cancer related fatigue in men with prostatic cancer, at least 2 months after the end of their radiation therapy. Participants will receive weekly treatments for 6 weeks.

The aims of the study are as follows:

Aim 1: To conduct a feasibility study to determine whether a 6-week SMT intervention can decrease CRF among prostate cancer survivors who have received radiation therapy and have CRF.

Aim 2: To determine whether the hypothesized decrease in CRF is due to SMT modulating the immune system of subjects with CRF. The researchers hypothesize that SMT will decrease plasma concentrations of IL-6 (a pro-inflammatory cytokine) more than LT and that the decrease in plasma IL-6 will mediate the decrease in fatigue as assessed with the MFI.

Aim 3: To determine whether SMT improves self-reported quality of life, depression, and anxiety more than LT, as assessed (respectively) by the Quality of Life, Enjoyment, and Satisfaction Questionnaire - short form (Q-LES-Q), the Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR), and the Generalized Anxiety Disorder 7-item (GAD-7) scale.

Aim 4: To evaluate the peripheral physiological changes associated with treatment of CRF. The researchers predict that treatment with SMT will cause a progressive increase in wearable measures of activity and step count, improved sleep quality (duration and latency), and decrease in pulse over 6 weeks when compared to baseline measures.

Aim 5: To determine if valid and useful tests of SMT effectiveness for treating CRF can be obtained through daily self-report ratings of fatigue and continuous monitoring of physiological signs. The researchers predict that SMT will cause a significant decrease in daily self-ratings of fatigue and mood when compared to baseline ratings and that the decreases in daily self-ratings of fatigue and mood observed with SMT will correlate with changes in Q-LES-Q, QIDS-SR, GAD-7 scores obtained at in-person visits as well as physiological signs.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

8

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30329
        • Executive Park 12

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

45 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Descrizione

Inclusion Criteria:

  • Diagnosis of prostate cancer
  • At least 2 months after the end of radiation therapy
  • Brief Fatigue Inventory (BFI) score of >25
  • Satisfactory results of screening safety labs, serum testosterone test and drug test
  • Ability to understand study procedures and to comply with them for the entire length of the study

Exclusion Criteria:

  • Inability to lay supine for one hour at a time, given the nature of the massage intervention
  • Actively suicidal or homicidal
  • Medical conditions felt to be clinically contributing to fatigue based on the investigator's history, physical examination, and assessment: anemia (hemoglobin less than 10 g/dl), hypothyroidism (thyroid stimulating hormone greater than 4.6 microUnits per milliliter (mcU/mL)), uncontrolled pain, or medical problems associated with fatigue, including: chronic obstructive pulmonary disease, congestive heart failure, renal disease, hepatic dysfunction, autoimmune disease, neurological disorders such as multiple sclerosis or Parkinson's disease, and poorly controlled sleep apnea
  • Medications felt to be clinically contributing to fatigue based on the investigator's history, physical examination, and assessment. Those may include: antidepressants, chronic use of long-acting anxiolytics or neuroleptics
  • Treatment with high dose systemic corticosteroids or continuous use of other immunosuppressants within the past 30 days
  • Unable to comply with the protocol for any reason
  • Use of non-steroidal anti-inflammatory drugs; aspirin use is allowed but must be tracked
  • Illicit drug use
  • Shift work
  • Currently dieting
  • Excessive, regular use of alcohol (more than two 5 ounce glasses of wine or equivalents/day) or a history of binge drinking (more than 7 drinks/24 hour period) within the last 6 months
  • Have used massage as a therapeutic modality (medical or psychological) at any point for the treatment of medical conditions
  • Have massages on a regular basis, defined as receiving 4 or more massages per year for the last 5 years
  • Currently employing any other complementary and alternative medicine (CAM) manual therapy and/or holistic therapies to treat a perceived health problem
  • Unable to read and understand the informed consent document because of language difficulties
  • Inability or unwillingness to give written informed consent

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Swedish Massage Therapy
Participants in this arm will receive Swedish massage, which is the most commonly offered and best-known type of massage.
Altro: Swedish Massage Therapy
The therapist uses non-aromatic massage oil to facilitate making long, smooth strokes over the body. Swedish massage is done with the subject covered by a sheet, a technique called "draping." One part of the body is uncovered, massaged, and then covered up before moving onto another part of the body. Primary techniques used in the research protocol therapy are: effleurage, petrissage, tapotement. These will be administered according to a very specific, standardized protocol. The total session time will be 45 minutes.
Altri nomi:
  • SMT
Comparatore attivo: Light Touch Intervention
Participants in this arm will receive light touch only.
Altro: Light Touch Intervention
The light-touch research intervention is based on the concept that there will be a noticeable effect with regard to massage when compared to light-touch alone without the massage. The protocol followed will be the same as the massage protocol other than that the therapist will use light-touch only. The total session time will be 45 minutes.
Altri nomi:
  • LT

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Multidimensional Fatigue Inventory (MFI) score
Lasso di tempo: Baseline, Week 6
Multidimensional Fatigue Inventory (MFI) is a brief (20-item) self-report instrument that assesses 5 dimensions (subscales) of fatigue, including general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Respondents indicate their level of agreement with fatigue related statements on a 5 point scale ranging from "Yes, that is true" = 1 to "No that is not true" = 5. Possible scores for each subscale range from 4 (no fatigue) to 20 (maximum fatigue). The primary outcome measure for this study will be the total of four MFI subscales (general fatigue, physical fatigue, reduced activity, and reduced motivation).
Baseline, Week 6

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Patient-Reported Outcome Measurement System (PROMIS) Fatigue Scale score
Lasso di tempo: Baseline, Week 6
The PROMIS Fatigue Scale is an 7-item self-report scale. Respondents indicate how tired they feel by answering fatigue related questions (such as "How often did you feel tired?") on a scale of 1 (never) to 5 (always). The summary score ranges from 7 to 35 with higher values equating to increased levels of fatigue.
Baseline, Week 6
Change in plasma IL-6
Lasso di tempo: Baseline, Week 6
To examine the effects of SMT on the pro-inflammatory cytokine IL-6, blood will be drawn at each study visit and the plasma levels of IL-6 will be compared between prior to treatment and at treatment completion.
Baseline, Week 6
Change in Quality of Life, Enjoyment, and Satisfaction Questionnaire - short form (Q-LES-Q) score
Lasso di tempo: Baseline, Week 6
The Q-LES-Q short form is a 16-item, patient-administered instrument, which asks participants to rate their satisfaction with 13 specific areas of life, specifically, overall sense of well-being, medication, and overall life satisfaction and contentment during the past week. Responses are given on a 5-point scale where 1 = very poor and 5 = very good. Items 1-14 are added in order to obtain a summary score while the last two items are stand alone questions. Total scores range from 14 to 70 and higher scores indicate greater satisfaction with life.
Baseline, Week 6
Change in Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) score
Lasso di tempo: Baseline, Week 6
The QIDS-SR is a 16-item questionnaire covering nine diagnostic symptom domains that characterize a major depressive episode (sleep disturbance, sad mood, changes in appetite/weight, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, and psychomotor agitation/retardation). The total score can range from 0 -27. A score of 1-5 equate to no depression while a score of 21-27 indicates very severe depression.
Baseline, Week 6
Change in Generalized Anxiety Disorder 7-item (GAD-7) Scale score
Lasso di tempo: Baseline, Week 6
The GAD-7 is a 7-item, well-validated patient self-report scale of anxiety. Participants respond to statements to indicate how often they have been bothered by specified symptoms of anxiety (such as "feeling nervous, anxious, or on edge). Response choices include 0 = not at all sure, 1 = several days, 2 = over half the days, and 3 = nearly every day. Total scores range from 0 to 21 with higher scores indicating increased anxiety.
Baseline, Week 6
Change in circadian variation of activity
Lasso di tempo: Baseline, Week 6
Activity level will be assessed by examining circadian variation (daily biologic cycles) of activity. Daily activity of each participant will be measured with a multisensor wristband device (Jawbone UP3). The device will collect data on activity levels and sleep metrics as participants wear the device throughout the study.
Baseline, Week 6
Change in step count
Lasso di tempo: Baseline, Week 6
The number of steps the participant takes each day will be measured with a multisensor wristband device (Jawbone UP3). The device will collect data on activity levels and sleep metrics as participants wear the device throughout the study.
Baseline, Week 6
Change in sleep duration
Lasso di tempo: Baseline, Week 6
The number of hours the participant sleeps each night will be measured with a multisensor wristband device (Jawbone UP3). The device will collect data on activity levels and sleep metrics as participants wear the device throughout the study.
Baseline, Week 6
Change in sleep latency
Lasso di tempo: Baseline, Week 6
The amount of time it takes for the participant to fall asleep will be measured with a multisensor wristband device (Jawbone UP3). The device will collect data on activity levels and sleep metrics as participants wear the device throughout the study.
Baseline, Week 6
Change in Automated Monitoring of Symptom Severity (AMoSS) survey score
Lasso di tempo: Baseline, Week 6
AMoSS is a smartphone app designed for longitudinal evaluation of mood states and sociability. Using this type of technology may help to better understand the day-to-day impact of SMT on the lives of cancer survivors with CRF, by means of a short pop-up survey that assesses sadness, anxiety, fatigue, irritability, and energy. Mood/fatigue will be assessed daily with reminders provided by the app via an alert.
Baseline, Week 6

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Emory University

Investigatori

  • Investigatore principale: Mark Rapaport, MD, Emory University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

22 gennaio 2018

Completamento primario (Effettivo)

31 marzo 2019

Completamento dello studio (Effettivo)

31 marzo 2019

Date di iscrizione allo studio

Primo inviato

13 giugno 2017

Primo inviato che soddisfa i criteri di controllo qualità

13 giugno 2017

Primo Inserito (Effettivo)

14 giugno 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 giugno 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 giugno 2019

Ultimo verificato

1 giugno 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB00095260

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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