Body Mind Training for Cancer Fatigue in Male Survivors

(HERO Trial)

No longer recruiting at 1 trial location

Overseen By Olivia R Foran

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must be taking: Hormone manipulation

Must not be taking: Chemotherapy, Radionucleotides

Disqualifiers: Suicidality, Major depression, Others

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

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Body Mind Training (BMT), including practices like Tai Chi and Qigong, can reduce fatigue in male cancer survivors. It compares BMT to body training (BT) alone and usual care. Researchers are also examining how BMT might influence biological processes related to inflammation and gene expression. Men who have survived cancer, feel consistently tired, and aren't currently active may be suitable for this study. Participants should live near New Brunswick or Newark and be able to attend sessions in person. As an unphased trial, this study offers a unique opportunity to explore innovative ways to manage fatigue and improve quality of life.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are currently receiving certain chemotherapy treatments or other specific therapies, you may not be eligible to participate.

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

Research has shown that Body Mind Training (BMT), which includes activities like Tai Chi and Qigong, is safe for people with cancer. A review found that these exercise programs usually cause only minor side effects. Another study found that home exercises are safe and easy to maintain, with participants mostly reporting only minor issues.

For Body Training (BT), which involves physical exercise, studies also confirm its safety. Moderate exercise can help reduce tiredness and improve fitness in cancer survivors. It is considered safe and effective. Another study showed that community exercise programs can be tailored for cancer survivors, offering benefits without major risks.

Overall, both BMT and BT appear well-tolerated by cancer survivors, with only minor side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Body Mind Training (BMT) because it uniquely combines physical and mental exercises to combat cancer-related fatigue in male survivors. Unlike standard treatments that often focus solely on physical activity or medication, BMT emphasizes the connection between mental and physical health. This holistic approach could provide a more comprehensive solution to fatigue by potentially improving both energy levels and mental well-being. Additionally, the inclusion of Body Training (BT) allows researchers to isolate and assess the added benefits of mental training in this context.

What evidence suggests that this trial's treatments could be effective for reducing cancer fatigue in male survivors?

This trial will compare Body Mind Training (BMT) and Body Training (BT) with usual care (UC) to reduce fatigue in male cancer survivors. Studies have shown that BMT, which includes activities like Tai Chi and Qigong, can significantly reduce tiredness in cancer survivors. These mind-body exercises effectively boost energy levels and can also alleviate issues like depression.

For BT, exercises such as strength training and aerobic workouts have proven effective in reducing cancer-related fatigue. Research indicates that supervised exercise programs are safe and beneficial for managing fatigue in cancer survivors. Both BMT and BT are promising approaches being tested in this trial to help those recovering from cancer feel less tired. ^{6 7 8 9 10}

Who Is on the Research Team?

Anita Y Kinney, PhD, RN

Principal Investigator

Rutgers, The State University of New Jersey

Michael R. Irwin, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

Men over 55, inactive with fatigue after cancer treatment, living near New Brunswick or Newark. They must have had certain cancers and finished therapy at least 3 months ago or been on hormone therapy for prostate cancer for over 4 months. Excluded if severely depressed, suicidal, very ill, practicing similar therapies recently, non-English speakers, or with specific medical conditions.

Inclusion Criteria

I can travel to attend classes and assessments.

I have been diagnosed with a specific type of cancer before.

Lives within 75 miles of New Brunswick or Newark

Exclusion Criteria

Your PHQ-9 score is higher than 12.

Inability to speak and read English proficiently

Unable to understand informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants undergo a 12-week Body Mind Training (BMT) intervention to reduce fatigue

12 weeks

Weekly sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Visits at week 13, 3 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Body Mind Training (BMT)
• Body Training (BT)
• Usual Care (UC)

Trial Overview Project HERO tests Body Mind Training (BMT) against Body Training (BT) and Usual Care (UC) to see if BMT reduces fatigue in male cancer survivors. It's a randomized trial that also looks at inflammation and gene changes possibly affected by the training.

How Is the Trial Designed?

Group I: Usual care (UC): Experimental Treatment 1 Intervention

Control

Group II: Body Mind Training (BMT) Experimental Treatment 1 Intervention

Body mind training

Group III: Body Training (BT) Active Control 1 Intervention

Body training only

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

University of New Mexico

Collaborator

Trials

393

Recruited

3,526,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8200642/

Effects of Mindfulness-Based Interventions on Fatigue in ... MBIs show promise in improving fatigue and vitality/vigor in cancer survivors. More rigorous trials are needed to address current gaps in the evidence base.

2. bmccomplementmedtherapies.biomedcentral.com bmccomplementmedtherapies.biomedcentral.com/articles/10.1186/s12906-025-04988-7

Project HERO: a randomized trial of Tai Chi qigong versus ... Fatigue is often one of the most commonly reported symptoms in older male cancer survivors, but it is also one of the least understood ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1744388123000920

Mind-body therapies adjuvant to chemotherapy improve ... This systematic review and meta-analysis demonstrates significant improvements in fatigue with mind-body therapy interventions for colorectal cancer patients ...

4. link.springer.com link.springer.com/article/10.1007/s00432-024-05813-3

The effectiveness of mind-body therapy and physical ... The results demonstrated that complementary therapies, encompassing MBT and physical training, were effective in alleviating depressive symptoms ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8744122/

Tai Chi and other mind–body interventions for cancer-related ... The primary outcome will be changes in the fatigue state as evaluated by validated scales. We will perform a Bayesian NMA to analyse all the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8834842/

Effects of Exercise Programs on Physical Factors and Safety in ... The most significant result of this systematic review is that training program interventions seem to be safe in adult patients with cancer and ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2589537023001141

Harms of exercise training in patients with cancer ... Exercise is recommended for people with cancer. The aim of this study was to evaluate the harms of exercise in patients with cancer undergoing systemic ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4821160/

Community-based exercise program effectiveness and ... This training included an overview of cancer statistics, terminology, staging, and standard treatment options as well as education on common metastatic spread ...

9. ascopubs.org ascopubs.org/doi/10.1200/JCO.24.00333

Randomized Controlled Trial of a Virtually Delivered ... Mindfulness-based stress management (MBSM) to reduce anxiety and depression in cancer survivors is recommended by the ASCO Guideline.

10. link.springer.com link.springer.com/article/10.1007/s11764-025-01778-5

Feasibility, safety, and adherence of home-based exercise ... Home-based exercise interventions are feasible and safe for people diagnosed with cancer, with minor adverse events being the most common.