RECRUITING

Bright White Light Therapy in Reducing Cancer-Related Fatigue and Depression in Advanced Prostate Cancer Patients Undergoing Treatment With ADT Combination Therapy

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Conditions

Advanced Prostate CarcinomaMetastatic Prostate CarcinomaProstate CarcinomaStage III Prostate Cancer AJCC v8Stage IV Prostate Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial tests how well bright white light (BWL) therapy works in reducing cancer-related fatigue and depression in patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who are undergoing treatment with antiandrogen therapy (ADT) combination therapy. Combination treatment including ADT plus chemotherapy and androgen receptor (AR) targeted therapy or ADT plus AR targeted therapies work by reducing testosterone. Most prostate tumor cells rely on testosterone to help them grow; therefore, ADT combination therapy causes prostate tumor cells to die or to grow more slowly leading to improved overall survival in men with advanced prostate cancer when compared with ADT alone. However, lower levels of testosterone is also commonly associated with worsening fatigue and depression. If prolonged and severe, these complications can alter patient treatment plans, impacting not just quality of life, but leading to inadequate cancer control. BWL therapy is a type of phototherapy that utilizes bright white full-spectrum light, either through a light box or light therapy glasses to help regulate circadian rhythms. Circadian rhythms are physical, mental, and behavioral changes that follow a 24-hour cycle, including the sleep-wake cycle which can become disrupted in cancer patients undergoing treatment, leading to increased fatigue. Additionally, exposure to bright light may increase the production of serotonin, a neurotransmitter that is associated with mood regulation. BWL therapy with AYOpro light therapy glasses may serve as a supportive care measure for men with advanced prostate to help reduce fatigue, as well as improve mood and overall quality of life during ADT combination therapy to maintain cancer care without suffering complications of therapy.

Official Title

Phase 2 Study of Bright White Light During Treatment With ADT Combination Therapy in Men With Advanced Prostate Cancer to PreServe PHysIcal and MeNtal HEalth (SHINE)

Quick Facts

Study Start:2024-07-09
Study Completion:2027-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05869682

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must have histologically or cytologically confirmed prostate cancer
  2. * Participants must have radiographic evidence of measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 10 mm ( \>= 1 cm) with computed tomography (CT) scan or magnetic resonance imaging (MRI), or metastatic lesions as identified as related to prostate cancer on a standard technetium bone scan. Alternatively patients may have radiographic evidence of metastatic disease on an Axumin or prostate-specific membrane antigen (PSMA)-positron emission tomography (PET) scan
  3. * Eligible for treatment with ADT plus docetaxel (planned for 6 cycles or fewer) plus abiraterone acetate and prednisone or darolutamide (triplet therapy), or ADT plus enzalutamide, apalutamide, or darolutamide (doublet therapy). Prior use of ADT with a gonadotropin hormone-releasing hormone (GnRH) agonist or antagonist, or prior orchiectomy is allowed
  4. * Age \>= 60 years
  5. * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
  6. * Expected time to next treatment of \>= 12 months and life expectancy of \>= 18 months, as determined by a study Investigator
  7. * Leukocytes \>= 3,000/mcL
  8. * Absolute neutrophil count \>= 1,500/mcL
  9. * Platelets \>= 100,000/mcL
  10. * Total bilirubin =\< institutional upper limit of normal (ULN)
  11. * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional ULN
  12. * Creatinine =\< institutional ULN OR
  13. * Glomerular filtration rate (GFR) \>= 50 mL/min/1.73 m\^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m\^2
  14. * Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  15. * For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  16. * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  17. * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  18. * Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better
  19. * Ability to understand and the willingness to sign a written informed consent document
  20. * Participants are still eligible and may proceed with the protocol and bright white light therapy if they discontinue baseline hormonal treatment, but plan to continue with another of the eligible treatments. However, if they discontinue treatment due to cancer progression, they should not continue on the protocol
  1. * Participants receiving docetaxel cannot have metastatic castration-resistant prostate cancer as the expected median time to progression to next therapy is \< 12 months
  2. * Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia
  3. * Prior treatment with combination hormonal therapy with abiraterone acetate, enzalutamide, apalutamide, or darolutamide for participants planning to start treatment with abiraterone acetate, enzalutamide, apalutamide, or darolutamide
  4. * Participants who are receiving any other investigational agents
  5. * Participants with brain metastases are ineligible due to the limited life expectancy of men with prostate cancer metastases to brain
  6. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study
  7. * Histologic evidence of small cell prostate cancer
  8. * Symptomatic skeletal event complication of prostate cancer such as cord compression, fracture, or need for radiation or surgery to a bone lesion within 6 months
  9. * Uncontrolled pain related to prostate cancer or separate chronic condition
  10. * Visceral crisis from prostate cancer suggesting rapidly progressive disease and life expectancy of \< 18 months
  11. * Participants with uncontrolled intercurrent illness
  12. * Concurrent second active malignancy
  13. * Severe sleep disorders (e.g. Narcolepsy)
  14. * Eye Diseases which limit the ability of light to be processed (e.g. untreated cataracts, severe glaucoma, macular degeneration, blindness, pupil dilation problems or other retinal disorder)
  15. * Severe psychological impairment (e.g., bipolar disorder or manic episodes)
  16. * Current employment in night shift work
  17. * Previous use of light therapy to alleviate fatigue or depressive symptoms
  18. * Currently recovering from previous eye surgery within the past 6 months that causes eye irritation
  19. * Sensitivity to light, epilepsy, or a history of seizures

Contacts and Locations

Principal Investigator

William Dale
PRINCIPAL_INVESTIGATOR
City of Hope Medical Center

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

  • William Dale, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-09
Study Completion Date2027-12-01

Study Record Updates

Study Start Date2024-07-09
Study Completion Date2027-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Prostate Carcinoma
  • Metastatic Prostate Carcinoma
  • Prostate Carcinoma
  • Stage III Prostate Cancer AJCC v8
  • Stage IV Prostate Cancer AJCC v8