57 Participants Needed

Massage Therapy for Prostate Cancer-Related Fatigue

(mPROSTATE Trial)

SS
Overseen BySusan Sharry
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This phase II trial investigates the effect of massage in decreasing prostate cancer-related fatigue. Massage therapy has well known health benefits. This trial aims to find out if massage and touch therapies reduce fatigue due to cancer, and to learn if these therapies are better than traditional medicine or psychology for cancer related fatigue.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, certain medications like corticosteroids, anti-inflammatory drugs, and those for anxiety or depression may need to be stable or necessary for your wellbeing, as judged by the investigator.

What data supports the effectiveness of the treatment Massage Therapy for Prostate Cancer-Related Fatigue?

Research shows that massage therapy can significantly reduce cancer-related fatigue and improve symptoms like pain, anxiety, and stress in cancer patients. Studies have found that massage therapy leads to a substantial improvement in symptom scores, with benefits lasting up to 48 hours after treatment.12345

Is massage therapy safe for people with cancer-related fatigue?

Massage therapy is generally considered safe for people with cancer-related fatigue, and it may help reduce symptoms like anxiety and pain. Studies suggest that when modified appropriately, massage therapy can be a beneficial supportive treatment for cancer patients.13467

How is massage therapy different from other treatments for prostate cancer-related fatigue?

Massage therapy is unique because it is a non-drug approach that uses physical touch to help relieve fatigue, unlike other treatments that may involve medication. It focuses on relaxation and improving overall well-being, which can be particularly beneficial for managing fatigue in prostate cancer patients.89101112

Research Team

MH

Mark H Rapaport

Principal Investigator

Huntsman Cancer Institute/ University of Utah

Eligibility Criteria

Men over 45 with prostate cancer who've finished radiation therapy at least 2 months ago but no more than 6 years, currently on androgen deprivation therapy, experiencing significant fatigue not caused by other conditions like anemia or hypothyroidism. They must be able to lay down for an hour and not have used massage for fatigue before.

Inclusion Criteria

I have been diagnosed with fatigue related to my cancer.
I am on hormone therapy for cancer, and my testosterone is below 20 ng/ml.
My fatigue is not caused by other health issues or medications.
See 9 more

Exclusion Criteria

Inability to comply with the protocol for any reason
I haven't taken steroids or immunosuppressants in the last 6 months, unless needed for my health.
Current substance use diagnosis or current diagnoses of specific psychiatric disorders
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Swedish Massage Therapy (SMT), Light Touch (LT), or no intervention for 6 weeks

6 weeks
6 visits (in-person)

Follow-up

Participants are monitored for sustained effects of the intervention on cancer-related fatigue

12 weeks
2 visits (in-person)

Treatment Details

Interventions

  • Massage Therapy
  • Sham Intervention
Trial OverviewThe mPROSTATE study is testing if massage can reduce cancer-related fatigue in men with prostate cancer better than traditional treatments. Participants will receive either real massage therapy or a sham intervention while their responses are monitored through questionnaires.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Arm I (SMT)Experimental Treatment2 Interventions
Patients receive SMT over 45 minutes once weekly for 6 weeks.
Group II: Arm III (waitlist)Active Control1 Intervention
Patients receive no intervention for 6 weeks.
Group III: Arm II (LT)Placebo Group2 Interventions
Patients receive LT over 45 minutes once weekly for 6 weeks.

Massage Therapy is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Massage Therapy for:
  • Cancer-related fatigue
  • Pain management
  • Anxiety relief
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Approved in European Union as Oncology Massage for:
  • Cancer-related fatigue
  • Symptom management in oncology
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Approved in Canada as Massage Therapy for:
  • Cancer-related fatigue
  • Palliative care

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials
1,169
Recruited
1,623,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Massage therapy significantly reduces cancer-related fatigue (CRF) in patients, with a standardized mean difference of -1.69 based on a meta-analysis of 11 studies involving 789 patients.
Reflexology and Chinese massage were found to be particularly effective, and the optimal treatment regimen for maximum benefit is twice a week for 3-5 weeks, with each session lasting 20-40 minutes.
Massage therapy significantly improves cancer-related fatigue in cancer patients: a meta-analysis of randomized controlled trials.Shan, S., Lin, L., Fang, Q., et al.[2023]
In a study involving 1,290 cancer patients over three years, massage therapy led to a significant reduction in symptom severity, with scores decreasing by approximately 50% across various symptoms like pain, fatigue, and anxiety.
Outpatients experienced about 10% greater improvement compared to inpatients, and the benefits of massage therapy persisted for at least 48 hours after treatment, indicating its effectiveness in managing cancer-related symptoms.
Massage therapy for symptom control: outcome study at a major cancer center.Cassileth, BR., Vickers, AJ.[2022]
Weekly Swedish massage therapy (SMT) significantly reduced cancer-related fatigue (CRF) in breast cancer survivors, with a mean reduction of 16.50 points on the Multidimensional Fatigue Inventory after 6 weeks, compared to only 8.06 points for light touch and an increase for the waitlist control.
The study involved 66 female breast cancer survivors and demonstrated that SMT is a safe and effective manual intervention for alleviating persistent fatigue, highlighting its potential as a treatment option for CRF.
Massage therapy decreases cancer-related fatigue: Results from a randomized early phase trial.Kinkead, B., Schettler, PJ., Larson, ER., et al.[2019]

References

Massage therapy significantly improves cancer-related fatigue in cancer patients: a meta-analysis of randomized controlled trials. [2023]
Massage therapy for symptom control: outcome study at a major cancer center. [2022]
Massage therapy decreases cancer-related fatigue: Results from a randomized early phase trial. [2019]
The value of massage therapy in cancer care. [2011]
Massage Therapy in Outpatient Cancer Care: A Metropolitan Area Analysis. [2019]
Factors Affecting the Severity of Fatigue during Radiotherapy for Prostate Cancer; an Exploratory Study. [2022]
Therapeutic Massage During Chemotherapy and/or Biotherapy Infusions: Patient Perceptions of Pain, Fatigue, Nausea, Anxiety, and Satisfaction. [2022]
Methylphenidate for fatigue in ambulatory men with prostate cancer. [2021]
Men's perception of fatigue when newly diagnosed with localized prostate cancer. [2007]
Investigating the relationships between quality of life, fatigue and leisure time physical activity in prostate cancer patients. [2019]
Characteristics and predictors of fatigue among men receiving androgen deprivation therapy for prostate cancer: a controlled comparison. [2022]
Non-pharmacological interventions for cancer-related fatigue in men treated for prostate cancer: A systematic review. [2020]