Light Therapy + Occupational Therapy for Genitourinary Cancers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Severe sleep disorders, Eye diseases, Severe psychological impairment, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 3 months

224 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how light therapy and occupational therapy might reduce fatigue in individuals with genitourinary cancers, such as prostate, kidney, or bladder cancer. Light therapy involves using special light glasses each morning, while occupational therapy includes guided sessions to help manage daily activities. Participants will either try light therapy alone, occupational therapy alone, both therapies together, or continue with their usual cancer care. This trial suits those with mild to moderate fatigue (frequent tiredness) who are currently receiving cancer treatments like chemotherapy or radiotherapy. As an unphased trial, it offers a unique opportunity to explore innovative therapies that could enhance quality of life during cancer treatment.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves light and occupational therapy, it seems likely that you can continue your existing treatments, especially since participants must be on active cancer treatment.

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

Research has shown that light therapy is generally safe, particularly for managing tiredness in cancer patients. A review of studies found it well-tolerated with few side effects. Light therapy has been tested in patients with various types of cancer, and most have not experienced significant problems.

Studies suggest that occupational therapy is a safe and helpful part of cancer care. It has reduced hospital readmissions for cancer patients, highlighting its benefits and safety.

Overall, both light therapy and occupational therapy have good safety records in cancer care, making them promising options for managing cancer-related tiredness. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores combining light therapy and occupational therapy as a novel approach for genitourinary cancers. Unlike standard treatments like surgery, chemotherapy, and radiation, which can be invasive or carry significant side effects, this trial investigates non-invasive methods that could improve patients' quality of life. Light therapy, delivered through wearable glasses, is unique due to its potential to regulate mood and energy levels, while occupational therapy offers personalized support to help patients manage daily activities. This trial aims to determine if these therapies can complement traditional treatments, offering a holistic approach to care.

What evidence suggests that this trial's treatments could be effective for managing cancer-related fatigue in genitourinary cancer patients?

Research shows that bright white light therapy, which participants in this trial may receive, can reduce cancer-related tiredness. Several studies have found that it lessens fatigue and improves sleep quality for cancer patients. It may also alleviate insomnia, helping patients feel more rested.

Occupational therapy, another treatment option in this trial, plays a crucial role in cancer care. Studies suggest it enhances quality of life by helping cancer survivors manage everyday tasks more effectively. This trial will also explore the combination of both therapies, which might further aid in managing fatigue for patients with genitourinary cancers. ^{1 2 3 4 6}

Who Is on the Research Team?

William Dale

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with genitourinary cancers like prostate, kidney, and bladder cancer who are experiencing mild to moderate fatigue during treatment. They must speak English well enough to consent and have a life expectancy of at least six months. People with severe sleep disorders, psychological impairments, recent eye surgery or diseases affecting light processing in the eyes, sensitivity to light or seizures cannot participate.

Inclusion Criteria

Sufficiently fluent in English

I am willing and able to agree to participate on my own.

I am currently undergoing treatment such as chemotherapy, immunotherapy, or radiotherapy.

Exclusion Criteria

Severe psychological impairment (e.g., bipolar disorder or manic episodes)

I have a severe sleep disorder like narcolepsy.

Plans to travel across meridians during treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive light therapy and/or occupational therapy interventions for 3 months

3 months

6 follow-up sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Bright White Light Therapy
• Occupational Therapy

Trial Overview The study is testing whether combining bright white light therapy with occupational therapy can help reduce fatigue in patients undergoing treatment for genitourinary cancers. Light therapy is simple and low-cost while occupational therapy helps manage daily activities; together they might improve energy levels.

How Is the Trial Designed?

Group I: Arm III (OT, BWL) Experimental Treatment 3 Interventions

Patients self-administer 30 minutes of light delivered via light glasses every morning for 3 months. Patients attend 6 follow up sessions to address any questions regarding the wearable light therapy glasses and to complete the occupational therapist-led session over 60 minutes.

Group II: Arm II (OT) Experimental Treatment 2 Interventions

Patients undergo 6 occupational therapist-led sessions over 60 minutes each.

Group III: Arm I (BWL) Experimental Treatment 2 Interventions

Patients self-administer 30 minutes of light delivered via light glasses every morning for 3 months. Patients attend 6 follow up sessions to address any questions regarding the wearable light therapy glasses.

Group IV: Arm IV (Control) Active Control 2 Interventions

Patients undergo routine treatment and usual follow up care with their medical oncologist.

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

Approved in United States as Occupational Therapy for:

• Rehabilitation
• Physical disabilities
• Mental health conditions
• Cancer-related fatigue

Approved in European Union as Occupational Therapy for:

• Rehabilitation
• Physical disabilities
• Mental health conditions
• Cancer-related fatigue

Approved in Canada as Occupational Therapy for:

• Rehabilitation
• Physical disabilities
• Mental health conditions
• Cancer-related fatigue

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Androgen deprivation therapy (ADT) significantly improves lower urinary tract symptoms (LUTS) and quality of life (QoL) in patients with advanced prostate cancer, as shown by a study of 65 patients over 12 months, with notable reductions in mean IPSS scores and improvements in urodynamic parameters.

Despite the overall benefits of ADT, a subset of patients (approximately 12.3%) continued to experience persistent LUTS and required catheterization, indicating that not all patients respond equally to this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower urinary tract symptoms in patients with advanced prostate cancer: What are the outcomes of androgen deprivation therapy? Akpayak, IC., Shuaibu, SI., Ofoha, CG., et al.[2022]

In a study of 181 cancer patients, the main reasons for seeking occupational therapy were related to improving 'Activities and Participation' in their daily lives after treatment.

Patients showed significant improvements in both performance and satisfaction scores on the Canadian Occupational Performance Measurement (COPM) after occupational therapy, indicating its positive impact on everyday functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reasons for and outcome of occupational therapy consultation and treatment in the context of multidisciplinary cancer rehabilitation; a historical cohort study. Rijpkema, C., Duijts, SFA., Stuiver, MM.[2021]

In a study involving 63 older adults with cancer, occupational therapy (OT) and physical therapy (PT) showed a significant improvement in activity expectations and self-efficacy compared to usual care, although both groups experienced a decline in overall functional status.

Despite the positive effects of OT/PT on certain outcomes, challenges such as recruitment difficulties and logistical barriers hindered the implementation of the intervention, highlighting the need for improved access to these services for older cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Adults with Cancer: A Randomized Controlled Trial of Occupational and Physical Therapy. Pergolotti, M., Deal, AM., Williams, GR., et al.[2021]

In a study of 37 men with intermediate- or high-risk localized prostate cancer, a combination of 6 months of androgen-deprivation therapy (ADT) with abiraterone acetate and radiation therapy resulted in a 55% rate of undetectable prostate-specific antigen (PSA) levels at 12 months, indicating effective disease control.

The treatment was associated with manageable toxicity, primarily grade 3 hypertension in 32% of patients, and 81% of participants experienced testosterone recovery within a median time of 9.2 months, suggesting a favorable impact on quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination of Radiation Therapy and Short-Term Androgen Blockade With Abiraterone Acetate Plus Prednisone for Men With High- and Intermediate-Risk Localized Prostate Cancer. Koontz, BF., Hoffman, KE., Halabi, S., et al.[2021]

Androgen-deprivation therapy (ADT) for prostate cancer can significantly reduce quality of life (QoL) in patients, leading to issues like decreased cognitive function, self-esteem, libido, and increased risk of osteoporosis and fractures.

Intermittent ADT may be a promising alternative, as it shows similar effectiveness in managing prostate cancer while reducing side effects and improving QoL compared to continuous ADT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing outcomes and quality of life in the hormonal treatment of prostate cancer. Mottet, N., Prayer-Galetti, T., Hammerer, P., et al.[2006]

In a study of 60 men with nonmetastatic prostate cancer, those receiving androgen deprivation therapy (ADT) combined with radiation therapy (RTH) did not show significant increases in depressive symptoms compared to those receiving RTH alone, suggesting that ADT may not be a major risk factor for depression.

While there were fluctuations in depressive symptoms during the study, including decreases after stopping ADT, the overall effect sizes were small, indicating that ADT's impact on mental health may be minimal for patients already facing other treatment challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression and androgen deprivation therapy for prostate cancer: a prospective controlled study. Hervouet, S., Savard, J., Ivers, H., et al.[2018]

One year after radiotherapy, prostate cancer patients reported less pain and fewer physical limitations compared to their baseline measurements, indicating some improvement in quality of life (QoL).

Despite these improvements, patients still experienced worse mental health and vitality compared to a normal population, highlighting the need for supportive care during and after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective assessment of the quality of life before, during and after image guided intensity modulated radiotherapy for prostate cancer. Sveistrup, J., Mortensen, OS., Bjørner, JB., et al.[2018]

Occupational therapy interventions for adult cancer patients, although varied and based on small studies, showed positive outcomes when they were person-centered, individualized, and included regular monitoring, highlighting the importance of flexibility in care.

The review suggests that tailored programs that adapt to the patient's changing condition can effectively improve outcomes for cancer survivors, emphasizing the need for occupational therapists to collaborate with multidisciplinary teams and carefully select appropriate outcome measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational therapy intervention for cancer patients following hospital discharge: How and when should we intervene? A systematic review. Taylor, S., Keesing, S., Wallis, A., et al.[2021]

Occupational therapy can significantly improve the functional status and quality of life for adults with cancer, helping them engage in daily activities safely and independently.

Despite its benefits, occupational therapy is often underutilized by cancer patients, highlighting the need for increased awareness and referrals to these supportive services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational Therapy for Adults With Cancer: Why It Matters. Pergolotti, M., Williams, GR., Campbell, C., et al.[2022]

A 12-week occupational therapy intervention that included cognitive behavioral therapy significantly improved the quality of life (QoL) for 55 men treated for metastatic prostate cancer compared to a home program.

The improvements in QoL were linked to better occupational performance, as measured by the Canadian Occupational Performance Measure, indicating that targeted therapy can enhance daily living activities for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of occupational therapy on quality of life of patients with metastatic prostate cancer. A randomized controlled study. Huri, M., Huri, E., Kayihan, H., et al.[2023]

Citations

1. withpower.com withpower.com/trial/light-therapy-occupational-therapy-for-genitourinary-cancers-459fc

Light Therapy + Occupational Therapy for Genitourinary ... This clinical trial evaluates light therapy and occupational therapy in improving cancer related fatigue (CRF) patients with genitourinary cancers.

2. onclive.com onclive.com/view/dr-dorff-on-the-benefit-of-bright-white-light-therapy-on-obese-frailty-in-prostate-cancer

Dr. Dorff on the Benefit of Bright White Light Therapy ... Tanya Dorff, MD, discusses the effects of bright white light therapy on obese frailty in older men with prostate cancer.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10363736/

The effect of light therapy on sleep quality in cancer patients Several studies have shown that bright light therapy relieved fatigue, improved self-reported sleep quality, and reduced insomnia symptoms of ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05519878?tab=history&a=1

Record History | ver. 1: 2022-08-25 | NCT05519878 This clinical trial evaluates light therapy and occupational therapy in improving cancer related fatigue (CRF) patients with genitourinary cancers. Light ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40185343/

Effectiveness and Safety of Bright Light Therapy in ... Light therapy has showed promising results, providing a safe and potentially effective treatment for a variety of psychological symptoms.

6. ons.org ons.org/publications-research/onf/52/4/bright-white-light-therapy-nonpharmacologic-management-side-effects

Bright White Light Therapy for Nonpharmacologic ... Sample & Setting: 74 patients were accrued from a 24-bed acute leukemia unit at a cancer hospital in the midwestern United States. Methods & Variables: A ...