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

Primary Purpose

Advanced Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bright White Light Therapy
Combination Drug Therapy
Electronic Health Record Review
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Advanced Prostate Carcinoma

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group I (Immediate BWL therapy)

Group II (Delayed BWL therapy)

Arm Description

Patients wear AYOpro BWL therapy glasses starting on day 1 of SOC ADT combination therapy for 12 months on trial.

Patients wear AYOpro BWL therapy glasses starting 6 months after the start of SOC ADT combination therapy for 6 months on trial.

Outcomes

Primary Outcome Measures

Change in patient-reported fatigue
Will compare patient-reported fatigue between men treated with immediate versus delayed bright white light (BWL) therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT+ hormonal intensification). Measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue instrument. T test will be used to compare FACIT-Fatigue change score between two arms (T2 [3 month after treatment initiation] minus T1 [before or at treatment initiation]).

Secondary Outcome Measures

Difference in mood outcomes
Will compare the difference in mood between men with prostate cancer receiving immediate BWL therapy as compared with delayed BWL therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT + hormonal intensification). Measured by Patient Health Questionnaire (PHQ)-9 instrument measuring depressive symptoms. T test will be used to compare PHQ-9 change score between two arms (T2 [3 month after treatment initiation] minus T1 [before or at treatment initiation]).
Difference in geriatric assessments
Will compare the difference in geriatric assessments between men with prostate cancer receiving immediate BWL therapy as compared with delayed BWL therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT + hormonal intensification). Measured by Cancer and Aging Research Group- Geriatric Assessment (CARG-GA) and Geriatric 8 (G8) instruments. T test will be used to compare CARG-GA and G8 change scores between two arms (T2 [3 month after treatment initiation] minus T1 [before or at treatment initiation]).
Difference in overall quality of life
Will compare the difference in overall quality of life between men with prostate cancer receiving immediate BWL therapy as compared with delayed BWL therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT + hormonal intensification). Measured by Functional Assessment of Cancer Therapy (FACT)-Prostate (FACT-P) instrument. T test will be used to compare FACT-P change score between two arms (T2 [3 month after treatment initiation] minus T1 [before or at treatment initiation]).

Full Information

First Posted
May 8, 2023
Last Updated
August 22, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05869682
Brief Title
Bright White Light Therapy in Reducing Cancer-Related Fatigue and Depression in Advanced Pancreatic Cancer Patients Undergoing Treatment With ADT Combination 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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
February 2, 2027 (Anticipated)
Study Completion Date
February 2, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Carcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (Immediate BWL therapy)
Arm Type
Experimental
Arm Description
Patients wear AYOpro BWL therapy glasses starting on day 1 of SOC ADT combination therapy for 12 months on trial.
Arm Title
Group II (Delayed BWL therapy)
Arm Type
Experimental
Arm Description
Patients wear AYOpro BWL therapy glasses starting 6 months after the start of SOC ADT combination therapy for 6 months on trial.
Intervention Type
Procedure
Intervention Name(s)
Bright White Light Therapy
Other Intervention Name(s)
Bright Light Therapy, Bright White Light, BWL
Intervention Description
Wear AYOpro BWL therapy
Intervention Type
Drug
Intervention Name(s)
Combination Drug Therapy
Other Intervention Name(s)
Drug Therapy, Combination
Intervention Description
Receive SOC ADT combination therapy
Intervention Type
Other
Intervention Name(s)
Electronic Health Record Review
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in patient-reported fatigue
Description
Will compare patient-reported fatigue between men treated with immediate versus delayed bright white light (BWL) therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT+ hormonal intensification). Measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue instrument. T test will be used to compare FACIT-Fatigue change score between two arms (T2 [3 month after treatment initiation] minus T1 [before or at treatment initiation]).
Time Frame
Baseline to 3 months post antiandrogen therapy (ADT) combination treatment initiation
Secondary Outcome Measure Information:
Title
Difference in mood outcomes
Description
Will compare the difference in mood between men with prostate cancer receiving immediate BWL therapy as compared with delayed BWL therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT + hormonal intensification). Measured by Patient Health Questionnaire (PHQ)-9 instrument measuring depressive symptoms. T test will be used to compare PHQ-9 change score between two arms (T2 [3 month after treatment initiation] minus T1 [before or at treatment initiation]).
Time Frame
Baseline to 3 months post ADT combination treatment initiation
Title
Difference in geriatric assessments
Description
Will compare the difference in geriatric assessments between men with prostate cancer receiving immediate BWL therapy as compared with delayed BWL therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT + hormonal intensification). Measured by Cancer and Aging Research Group- Geriatric Assessment (CARG-GA) and Geriatric 8 (G8) instruments. T test will be used to compare CARG-GA and G8 change scores between two arms (T2 [3 month after treatment initiation] minus T1 [before or at treatment initiation]).
Time Frame
Baseline to 3 months post ADT combination treatment initiation
Title
Difference in overall quality of life
Description
Will compare the difference in overall quality of life between men with prostate cancer receiving immediate BWL therapy as compared with delayed BWL therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT + hormonal intensification). Measured by Functional Assessment of Cancer Therapy (FACT)-Prostate (FACT-P) instrument. T test will be used to compare FACT-P change score between two arms (T2 [3 month after treatment initiation] minus T1 [before or at treatment initiation]).
Time Frame
Baseline to 3 months post ADT combination treatment initiation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Dale
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Dale
Phone
626-256-4673
Email
wdale@coh.org
First Name & Middle Initial & Last Name & Degree
William Dale

12. IPD Sharing Statement

Learn more about this trial

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

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