Prostate CancerNCT03419585
The "PC-LIGHT" Study
A study testing Intervention systematic light exposure and Comparison systematic light exposure in people with Prostate Cancer and Sleep, run by Northwestern University at 1 site in United States.
Trial summary
Fatigue due to cancer and its treatment (for example, radiation therapy) can interfere with quality of life and can linger long after treatment has ended, yet research examining preventative approaches has produced limited clinical benefit. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Sleep, Depression
- What is being tested?
- Intervention systematic light exposure and Comparison systematic light exposure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been diagnosed with clinical localized prostate cancer,
- Are about to begin external beam radiation therapy (RT) for prostate cancer,
- Are 18 years of age or older,
- Are able to speak or read English,
- Have internet access.
Who cannot join
- History of light therapy use (e.g. systematic light exposure),
- Active infection
- History of chronic fatigue disorders
- Confounding underlying medical illnesses such as significant pre-existing anemia (Hb<10 gm/dl)
- Diagnosed or suspected psychiatric or medical condition that might contribute to fatigue (other than those caused by the cancer or its treatment)
- Hypothyroidism or documented history of hypothyroidism on thyroid replacement hormone within <3 months of initiating RT
Show all 13Show fewer
- History of bipolar disorder or mania
- History of seasonal affective disorder
- Diagnosed sleep apnea, restless legs, or other sleep disorders (not including insomnia) known to affect fatigue
- Use of photosensitizing medication
- Plans to travel across more than 2 time zones during the study
- Shift worker
- Adults unable to consent, individuals who are not yet adults, pregnant women, and prisoners will be excluded from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Univeristy Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Systematic Light Exposure to Prevent Fatigue in Prostate Cancer Patients
Fatigue due to cancer and its treatment (for example, radiation therapy) can interfere with quality of life and can linger long after treatment has ended, yet research examining preventative approaches has produced limited clinical benefit. The proposed study will provide information about systematic light exposure for the prevention of fatigue in prostate cancer patients undergoing radiation therapy and will investigate how it works. This study would facilitate the development of this potential preventative treatment, giving health care providers and cancer survivors a much-needed tool to help with cancer-related fatigue.
- Conditions
- Prostate Cancer, Sleep, Depression, Fatigue, Quality of Life
- Being tested
- Intervention systematic light exposure, Comparison systematic light exposure
- Medical subject headings
- Prostatic Neoplasms, Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention systematic light exposureDevice
30 minutes of intervention systematic light exposure daily
Comparison systematic light exposureDevice
30 minutes of comparison systematic light exposure daily
| Study group | Role | What they receive |
|---|---|---|
| Intervention light | Experimental | 30 minutes of intervention systematic light exposure daily for the course of radiation therapy (approximately 8 weeks). Receives: Device: Intervention systematic light exposure |
| Comparison light | Active comparator | 30 minutes of comparison systematic light exposure daily for the course of radiation therapy (approximately 8 weeks). Receives: Device: Comparison systematic light exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue FACIT-Fatigue scores
FACIT-Fatigue scores
Measured: Baseline
Fatigue
FACIT-Fatigue scores
Measured: Change from Baseline to the 4th week of the intervention
Fatigue
FACIT-Fatigue scores
Measured: Change from Baseline to the 8th week of the intervention
Fatigue
FACIT-Fatigue scores
Measured: Change from Baseline to 2 months after the intervention
Secondary outcomes (27)
Circadian activity rhythms
Actigraphy
Measured: Baseline
Circadian activity rhythms
Actigraphy
Measured: During the 4th week of the intervention
Circadian activity rhythms
Actigraphy
Measured: During the 8th week of the intervention
Circadian activity rhythms
Actigraphy
Measured: 2 months after the intervention
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: Baseline
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: During the 4th week of the intervention
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: During the 8th week of the intervention
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: 2 months after the intervention
Depressed mood
Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present.
Measured: Baseline
Depressed mood
Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present.
Measured: During the 4th week of the intervention
Depressed mood
Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present.
Measured: During the 8th week of the intervention
Depressed mood
Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present.
Measured: 2 months after the intervention
Cognitive Functioning
Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)
Measured: Baseline
Cognitive Functioning
Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)
Measured: During the 4th week of the intervention
Cognitive Functioning
Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)
Measured: During the 8th week of the intervention
Cognitive Functioning
Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)
Measured: 2 months after the intervention
Sexual and urinary functioning
3 items from the Sexual Adjustment Questionnaire \& 3 items from American Urological Association (AUA) symptom index
Measured: Baseline
Sexual and urinary functioning
3 items from the Sexual Adjustment Questionnaire \& 3 items from American Urological Association (AUA) symptom index
Measured: During the 4th week of the intervention
Sexual and urinary functioning
3 items from the Sexual Adjustment Questionnaire \& 3 items from American Urological Association (AUA) symptom index
Measured: During the 8th week of the intervention
Sexual and urinary functioning
3 items from the Sexual Adjustment Questionnaire \& 3 items from American Urological Association (AUA) symptom index
Measured: 2 months after the intervention
Cognitive functioning
Neuropsychological tests
Measured: Baseline
Cognitive functioning
Neuropsychological tests
Measured: During the 8th week of the intervention
Cognitive functioning
Neuropsychological tests
Measured: 2 months after the intervention
Health-related quality of life
Functional Assessment of Cancer Therapy - Prostate (FACT-P). From Radiation Therapy Oncology Group: "The FACT-P is a multidimensional, self-report QoL instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being."with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being.
Measured: Baseline
Health-related quality of life
Functional Assessment of Cancer Therapy - Prostate (FACT-P). From Radiation Therapy Oncology Group: "The FACT-P is a multidimensional, self-report QoL instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being."
Measured: During the 4th week of the intervention
Health-related quality of life
Functional Assessment of Cancer Therapy - Prostate (FACT-P). From Radiation Therapy Oncology Group: "The FACT-P is a multidimensional, self-report QoL instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being."with prostate cancer patients (1, 2, 3). It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being.
Measured: During the 8th week of the intervention
Health-related quality of life
Functional Assessment of Cancer Therapy - Prostate (FACT-P). From Radiation Therapy Oncology Group: "The FACT-P is a multidimensional, self-report QoL instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being."with prostate cancer patients (1, 2, 3). It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being.
Measured: 2 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start12 Dec 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa M. Wu, Northwestern University
- Investigators
- Lisa M Wu, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419585
- Sponsor's protocol ID
- STU00205260
- Status last verified
- Mar 2024
- First submitted
- 24 Jan 2018
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Light Exposure to Prevent Fatigue in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT03419585
- Acronym / sponsor ID
- STU00205260
- Conditions
- Prostate Cancer, Sleep, Depression, Fatigue, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fatigue due to cancer and its treatment (for example, radiation therapy) can interfere with quality of life and can linger long after treatment has ended, yet research examining preventative approaches has produced limited clinical benefit. The proposed study will provide information about systematic light exposure for the prevention of fatigue in prostate cancer patients undergoing radiation therapy and will investigate how it works. This study would facilitate the development of this potential preventative treatment, giving health care providers and cancer survivors a much-needed tool to help with cancer-related fatigue.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention light | Experimental | Device: Intervention systematic light exposure30 minutes of intervention systematic light exposure daily for the course of radiation therapy (approximately 8 weeks). |
| Comparison light | Active comparator | Device: Comparison systematic light exposure30 minutes of comparison systematic light exposure daily for the course of radiation therapy (approximately 8 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have been diagnosed with clinical localized prostate cancer,
- Are about to begin external beam radiation therapy (RT) for prostate cancer,
- Are 18 years of age or older,
- Are able to speak or read English,
- Have internet access.
Key exclusion criteria (13 listed)
- History of light therapy use (e.g. systematic light exposure),
- Active infection
- History of chronic fatigue disorders
- Confounding underlying medical illnesses such as significant pre-existing anemia (Hb<10 gm/dl)
- Diagnosed or suspected psychiatric or medical condition that might contribute to fatigue (other than those caused by the cancer or its treatment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention systematic light exposure30 minutes of intervention systematic light exposure daily | Device | Intervention light |
| Comparison systematic light exposure30 minutes of comparison systematic light exposure daily | Device | Comparison light |
Primary outcome
Fatigue FACIT-Fatigue scores
Time frame: Baseline
FACIT-Fatigue scores
Fatigue
Time frame: Change from Baseline to the 4th week of the intervention
FACIT-Fatigue scores
Fatigue
Time frame: Change from Baseline to the 8th week of the intervention
FACIT-Fatigue scores
Fatigue
Time frame: Change from Baseline to 2 months after the intervention
FACIT-Fatigue scores
27 secondary outcomes
Circadian activity rhythms
Time frame: Baseline
Circadian activity rhythms
Time frame: During the 4th week of the intervention
Circadian activity rhythms
Time frame: During the 8th week of the intervention
Circadian activity rhythms
Time frame: 2 months after the intervention
Sleep quality
Time frame: Baseline
Sleep quality
Time frame: During the 4th week of the intervention
Sleep quality
Time frame: During the 8th week of the intervention
Sleep quality
Time frame: 2 months after the intervention
Depressed mood
Time frame: Baseline
Depressed mood
Time frame: During the 4th week of the intervention
Depressed mood
Time frame: During the 8th week of the intervention
Depressed mood
Time frame: 2 months after the intervention
Cognitive Functioning
Time frame: Baseline
Cognitive Functioning
Time frame: During the 4th week of the intervention
Cognitive Functioning
Time frame: During the 8th week of the intervention
Cognitive Functioning
Time frame: 2 months after the intervention
Sexual and urinary functioning
Time frame: Baseline
Sexual and urinary functioning
Time frame: During the 4th week of the intervention
Sexual and urinary functioning
Time frame: During the 8th week of the intervention
Sexual and urinary functioning
Time frame: 2 months after the intervention
Cognitive functioning
Time frame: Baseline
Cognitive functioning
Time frame: During the 8th week of the intervention
Cognitive functioning
Time frame: 2 months after the intervention
Health-related quality of life
Time frame: Baseline
Health-related quality of life
Time frame: During the 4th week of the intervention
Health-related quality of life
Time frame: During the 8th week of the intervention
Health-related quality of life
Time frame: 2 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
RecruitingPhase 1/2
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RecruitingPhase 1
A Study of JNJ-98768111 in Participants With Advanced Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 3
A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
Prostatic Neoplasms, Castration-Resistant
RecruitingPhase 2
Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells
Metastatic Prostate Adenocarcinoma With Neuroendocrine Differentiation, Metastatic Prostate Neuroendocrine Carcinoma
RecruitingPhase 3
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial
Metastatic Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa M Wu, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention systematic light exposure and Comparison systematic light exposure in people with Prostate Cancer and Sleep, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue FACIT-Fatigue scores (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.