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

57 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 4 6 7}

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. ^{8 9 10 11 12}

Research Team

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.

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

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 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.

Participant Groups

Group I: Arm I (SMT) Experimental Treatment 2 Interventions

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

Group II: Arm III (waitlist) Active Control 1 Intervention

Patients receive no intervention for 6 weeks.

Group III: Arm II (LT) Placebo Group 2 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:

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+

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.

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]

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]

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]

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]

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 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]

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]

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 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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Massage therapy significantly improves cancer-related fatigue in cancer patients: a meta-analysis of randomized controlled trials. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Massage therapy for symptom control: outcome study at a major cancer center. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Massage therapy decreases cancer-related fatigue: Results from a randomized early phase trial. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The value of massage therapy in cancer care. [2011]

5. United States pubmed.ncbi.nlm.nih.gov

Massage Therapy in Outpatient Cancer Care: A Metropolitan Area Analysis. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Factors Affecting the Severity of Fatigue during Radiotherapy for Prostate Cancer; an Exploratory Study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Methylphenidate for fatigue in ambulatory men with prostate cancer. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Men's perception of fatigue when newly diagnosed with localized prostate cancer. [2007]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Investigating the relationships between quality of life, fatigue and leisure time physical activity in prostate cancer patients. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

Characteristics and predictors of fatigue among men receiving androgen deprivation therapy for prostate cancer: a controlled comparison. [2022]

12. Australia pubmed.ncbi.nlm.nih.gov

Non-pharmacological interventions for cancer-related fatigue in men treated for prostate cancer: A systematic review. [2020]