Massage Therapy for Prostate Cancer-Related Fatigue

(mPROSTATE Trial)

Overseen By Susan Sharry

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of Utah

Must be taking: Androgen deprivation therapy

Must not be taking: Opioids, Sedating antihistamines, Neuroleptics, Corticosteroids

Disqualifiers: Psychiatric disorders, Anemia, Hypothyroidism, Uncontrolled pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether massage therapy can reduce fatigue in men with prostate cancer. It compares different approaches: one group receives standard massage therapy, another receives a light touch treatment (sham intervention), and a third group remains on a waitlist with no intervention. The trial aims to determine if these therapies are more effective than traditional medical or psychological treatments for cancer-related fatigue. Men with prostate cancer who completed radiation therapy over two months ago and experience significant fatigue might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that massage therapy is generally safe for cancer patients. Studies have found that massage can reduce symptoms like nausea, pain, and fatigue related to cancer, making it a popular choice for improving quality of life during treatment.

Massage therapy is usually well-tolerated, with few negative effects reported. Patients often feel more relaxed and less stressed. Although specific studies on massage therapy's effects on fatigue related to prostate cancer are lacking, its overall safety is well-supported.

In summary, massage therapy is considered safe and could help manage fatigue in prostate cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about massage therapy for prostate cancer-related fatigue because it offers a non-invasive, drug-free approach to managing fatigue, unlike traditional treatments such as medication or physical therapy. This study compares two types of massage therapy: standard massage therapy (SMT) and a light-touch technique (LT). SMT is designed to provide deep relaxation and muscle relief, while LT uses gentle pressure to promote overall well-being. Both methods are promising because they could potentially improve quality of life without the side effects often associated with medication.

What evidence suggests that massage therapy is effective for reducing prostate cancer-related fatigue?

Research has shown that massage therapy can help reduce cancer-related tiredness. In this trial, participants in one arm will receive Swedish massage therapy (SMT) over six weeks. One study found that SMT significantly lowered fatigue levels compared to other treatments. Among various non-drug options, massage therapy proved most effective for easing fatigue. Another study found that both acupuncture and massage reduced pain in cancer patients, suggesting additional benefits. These findings indicate that massage therapy might be a promising choice for those experiencing fatigue due to prostate cancer. ^{1 4 6 7 8}

Who Is on the Research Team?

Mark H Rapaport

Principal Investigator

Huntsman Cancer Institute/ University of Utah

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Massage Therapy
• Sham Intervention

Trial Overview

The 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.

How Is the Trial Designed?

Group I: Swedish Massage Therapy (SMT) Experimental Treatment 1 Intervention

Patients receive SMT over 45 minutes once weekly for 6 weeks.

Group II: Waitlist Control (WLC) Active Control 1 Intervention

Patients will sit and relax for 45 minutes before completing study assessments at weeks 3 and 6.

Group III: Light Touch (LT) Placebo Group 1 Intervention

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:

Approved in United States as Massage Therapy for:

• Cancer-related fatigue
• Pain management
• Anxiety relief

Approved in European Union as Oncology Massage for:

• Cancer-related fatigue
• Symptom management in oncology

Approved in Canada as Massage Therapy for:

• Cancer-related fatigue
• Palliative care

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+

Published Research Related to This Trial

In a study of 58 prostate cancer patients, increased fatigue was found to negatively impact their quality of life, highlighting the importance of addressing fatigue in treatment plans.

The study also revealed that lower levels of leisure time physical activity were associated with higher fatigue levels, suggesting that promoting physical activity could help improve both fatigue and overall quality of life for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the relationships between quality of life, fatigue and leisure time physical activity in prostate cancer patients. Ozdemir, K., Keser, I., Sen, I., et al.[2019]

A review of eight studies involving 600 men with prostate cancer found that non-pharmacological interventions, particularly physical activity (aerobic and resistance exercise) and psychosocial support (education and cognitive behavioral therapy), are effective in managing cancer-related fatigue.

Physical activity showed the strongest benefit for reducing fatigue, highlighting the need for healthcare professionals to offer a variety of effective non-drug strategies to help men cope with this common side effect of prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-pharmacological interventions for cancer-related fatigue in men treated for prostate cancer: A systematic review. Larkin, D., Lopez, V., Aromataris, E.[2020]

Massage therapy has shown potential benefits for cancer patients, particularly in reducing anxiety and pain, making it a supportive therapy in medical centers.

Further research with larger and more consistent patient groups is needed to determine the most effective types of massage for different cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of massage therapy in cancer care. Myers, CD., Walton, T., Small, BJ.[2011]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Massage therapy decreases cancer-related fatigue: Results from a randomized early phase trial. Kinkead, B., Schettler, PJ., Larson, ER., et al.[2019]

In a 6-week study involving 32 men with advanced prostate cancer, methylphenidate significantly reduced fatigue levels compared to placebo, with 7 out of 10 participants showing clinically significant improvement in fatigue scores.

While methylphenidate was effective, it also caused increased blood pressure and heart rate in some patients, indicating the need for careful monitoring by oncologists during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methylphenidate for fatigue in ambulatory men with prostate cancer. Roth, AJ., Nelson, C., Rosenfeld, B., et al.[2021]

Prostate cancer patients undergoing androgen deprivation therapy (ADT) experience significantly increased fatigue over the first 12 months compared to controls, with worse fatigue reported at both 6 and 12 months after treatment initiation.

Higher baseline comorbidity scores and Gleason scores are associated with greater increases in fatigue, indicating that these factors may help identify patients at higher risk for fatigue during ADT, suggesting the need for targeted interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and predictors of fatigue among men receiving androgen deprivation therapy for prostate cancer: a controlled comparison. Nelson, AM., Gonzalez, BD., Jim, HS., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Massage therapy for symptom control: outcome study at a major cancer center. Cassileth, BR., Vickers, AJ.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Massage therapy can improve the quality of life for cancer patients by reducing symptoms such as pain, anxiety, and fatigue, but its availability in outpatient settings is limited.

In a study of 78 outpatient cancer centers, only 51.3% offered massage services, with a variety of modalities available, primarily provided by licensed massage therapists and other healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Massage Therapy in Outpatient Cancer Care: A Metropolitan Area Analysis. Cowen, VS., Miccio, RS., Parikh, B.[2019]

In a study of 26 Puerto Rican men undergoing radiotherapy for non-metastatic prostate cancer, sleep disturbance and depressive symptoms were found to be strongly correlated with fatigue at multiple time points during treatment.

The combination of sleep disturbance and depressive symptoms significantly contributed to fatigue levels, suggesting that clinicians should focus on managing these symptoms together to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Affecting the Severity of Fatigue during Radiotherapy for Prostate Cancer; an Exploratory Study. Gonzalez-Mercado, VJ., Marrero, S., Marrero-Falcon, MA., et al.[2022]

In a study of 16 men newly diagnosed with localized prostate cancer, it was found that fatigue is not directly caused by the cancer itself, suggesting that other factors may contribute to this common symptom.

The study highlights the importance of timely follow-up appointments after diagnosis, as patients need more information about their condition shortly after their initial visit to help manage their emotional and psychological well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Men's perception of fatigue when newly diagnosed with localized prostate cancer. Jonsson, A., Aus, G., Berterö, C.[2007]

In a study involving 58 cancer patients receiving chemotherapy and/or biotherapy, therapeutic massage (TM) significantly reduced pain, fatigue, nausea, and anxiety levels after just 20 minutes of treatment.

Patients expressed high satisfaction with TM, indicating its perceived value as an effective adjunct therapy to help manage side effects of cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Massage During Chemotherapy and/or Biotherapy Infusions: Patient Perceptions of Pain, Fatigue, Nausea, Anxiety, and Satisfaction. Robison, JG., Smith, CL.[2022]

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