Trial Title:
Bright White Light Therapy in Reducing Cancer-Related Fatigue and Depression in Advanced Prostate Cancer Patients Undergoing Treatment With ADT Combination Therapy
NCT ID:
NCT05869682
Condition:
Advanced Prostate Carcinoma
Metastatic Prostate Carcinoma
Prostate Carcinoma
Stage III Prostate Cancer AJCC v8
Stage IV Prostate Cancer AJCC v8
Conditions: Official terms:
Carcinoma
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Masking description:
In this study, only the designated study team member knows the participant's allocation.
Oncologists or clinical research associates collecting data are not informed of patient
allocation.
Intervention:
Intervention type:
Procedure
Intervention name:
Bright White Light Therapy
Description:
Wear AYOpro BWL therapy
Arm group label:
Group I (Immediate BWL therapy)
Arm group label:
Group II (Delayed BWL therapy)
Other name:
Bright Light Therapy
Other name:
Bright White Light
Other name:
BWL
Intervention type:
Drug
Intervention name:
Combination Drug Therapy
Description:
Receive SOC ADT combination therapy
Arm group label:
Group I (Immediate BWL therapy)
Arm group label:
Group II (Delayed BWL therapy)
Other name:
Drug Therapy, Combination
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Group I (Immediate BWL therapy)
Arm group label:
Group II (Delayed BWL therapy)
Intervention type:
Other
Intervention name:
Quality-of-Life Assessment
Description:
Ancillary studies
Arm group label:
Group II (Delayed BWL therapy)
Other name:
Quality of Life Assessment
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Group I (Immediate BWL therapy)
Arm group label:
Group II (Delayed BWL therapy)
Summary:
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.
Detailed description:
PRIMARY OBJECTIVE:
I. To evaluate whether patient-reported fatigue by the Functional Assessment of Chronic
Illness Therapy (FACIT)-Fatigue instrument at 3 months is lower in men with prostate
cancer receiving immediate bright white light therapy as compared with delayed bright
white light (BWL) therapy during ADT combination treatment (ADT + chemotherapy + hormonal
intensification OR ADT+ hormonal intensification).
SECONDARY OBJECTIVES:
I. To evaluate the difference in the following outcomes between men with prostate cancer
receiving immediate bright white light therapy as compared with delayed bright white
light (BWL) therapy during ADT combination treatment (ADT + chemotherapy + hormonal
intensification OR ADT + hormonal intensification):
Ia. Mood by the Patient Health Questionnaire (PHQ)-9 instrument measuring depressive
symptoms; Ib. Geriatric assessments by the Cancer and Aging Research Group- Geriatric
Assessment (CARG-GA) and Geriatric 8 (G8) instruments; Ic. Overall quality of life by the
Functional Assessment of Cancer Therapy (FACT)-Prostate (FACT-P) instrument.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (IMMEDIATE): Patients wear AYOpro BWL therapy glasses starting on day 1 of
standard of care (SOC) ADT combination therapy for 12 months on trial.
GROUP II (DELAYED): Patients wear AYOpro BWL therapy glasses starting 6 months after the
start of SOC ADT combination therapy for 6 months on trial.
Patients are followed for 52 weeks (total duration of the trial), or for 4 weeks
including after removal from protocol therapy or until death, whichever occurs first.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participants must have histologically or cytologically confirmed prostate cancer
- 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
- 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
- Age >= 60 years
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Expected time to next treatment of >= 12 months and life expectancy of >= 18 months,
as determined by a study Investigator
- Leukocytes >= 3,000/mcL
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Total bilirubin =< institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT])
=< 3 x institutional ULN
- Creatinine =< institutional ULN OR
- 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
- Human immunodeficiency virus (HIV)-infected participants on effective
anti-retroviral therapy with undetectable viral load within 6 months are eligible
for this trial
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV
viral load must be undetectable on suppressive therapy, if indicated
- 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
- 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
- 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
- Ability to understand and the willingness to sign a written informed consent
document
- 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
Exclusion Criteria:
- Participants receiving docetaxel cannot have metastatic castration-resistant
prostate cancer as the expected median time to progression to next therapy is < 12
months
- 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
- 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
- Participants who are receiving any other investigational agents
- Participants with brain metastases are ineligible due to the limited life expectancy
of men with prostate cancer metastases to brain
- History of allergic reactions attributed to compounds of similar chemical or
biologic composition to agents used in this study
- Histologic evidence of small cell prostate cancer
- 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
- Uncontrolled pain related to prostate cancer or separate chronic condition
- Visceral crisis from prostate cancer suggesting rapidly progressive disease and life
expectancy of < 18 months
- Participants with uncontrolled intercurrent illness
- Concurrent second active malignancy
- Severe sleep disorders (e.g. Narcolepsy)
- 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)
- Severe psychological impairment (e.g., bipolar disorder or manic episodes)
- Current employment in night shift work
- Previous use of light therapy to alleviate fatigue or depressive symptoms
- Currently recovering from previous eye surgery within the past 6 months that causes
eye irritation
- Sensitivity to light, epilepsy, or a history of seizures
Gender:
Male
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
William Dale
Phone:
626-256-4673
Email:
wdale@coh.org
Investigator:
Last name:
William Dale
Email:
Principal Investigator
Start date:
July 9, 2024
Completion date:
December 1, 2027
Lead sponsor:
Agency:
City of Hope Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
City of Hope Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05869682
