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The Effects of Light Therapy to Treat Cancer-related Side Effects

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ClinicalTrials.gov Identifier: NCT04418856
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : October 9, 2020
Sponsor:
Collaborator:
The Icelandic Centre for Research
Information provided by (Responsible Party):
Dr. Heiddis B Valdimarsdottir, Reykjavik University

Brief Summary:

Severe fatigue, depression, sleep problems and cognitive impairment are the most commonly reported side effects of cancer treatment. These aversive side effects are hypothesized to be related to the disruption of circadian rhythms associated with cancer and its treatment. Exposure to Bright White Light (BWL) has been found to synchronize the circadian activity rhythms but research with cancer patients has been scarce. Therefore, the proposed randomized control trial (RCT) will test if systematic light exposure (sLE) will minimize overall levels of cancer-related fatigue (CRF), depression, sleep problems and cognitive impairment among breast cancer patients undergoing breast cancer treatment (i.e., surgery, chemotherapy). SLE incorporates the delivery of harmless UV-protected BWL or Dim White Light (DWL - standard comparison in light studies) delivered to patients by using special glasses for 30 minutes each morning, during their treatment. The proposed study, including a delineated comparison condition, will investigate the effects of BWL on CRF, sleep, depression, cognition, circadian rhythms, and inflammation markers among patients undergoing breast cancer treatment. The proposed RCT could have major public health relevance as it will determine if an easy-to-deliver, inexpensive, and low patient burden intervention reduces common side effects (e.g., CRF, depression, cognitive impairment) of cancer treatment (i.e., surgery, chemotherapy).

Aim 1 - Assess whether Bright White Light (BWL) compared with Dim White Light (DWL) among breast cancer patients undergoing breast cancer treatment will minimize overall levels of CRF, depression, sleep problems, and cognitive impairment during and after breast cancer treatment.

Aim 2 - Determine whether the BWL intervention affects cortisol rhythms, circadian activity rhythms, melatonin rhythms, and inflammation markers that have been identified as correlates/causes of cancer-related side effects (e.g., CRF, depression, sleep problems).

Aim 3 - Exploratory: Explore whether the effects of BWL compared to DWL on the cancer-related side effects (e.g., CRF, cognitive impairment) are mediated by the beneficial effects of the BWL in synchronizing circadian rhythms.

Aim 4 - Exploratory: Explore potential moderators of the intervention including seasonality, chronobiology, personality, and social factors.


Condition or disease Intervention/treatment Phase
Breast Cancer Circadian Rhythms Fatigue Sleep Disturbance Cognitive Impairment Inflammatory Response Depression Device: Light Glasses (Experimental) Device: Light Glasses (Comparison) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Light Therapy to Treat Cancer-related Fatigue, Sleep Problems, Depression and Cognitive Impairment Among Breast Cancer Patients.
Actual Study Start Date : June 8, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental light: Breast cancer surgery and chemotherapy
Exposed to experimental systematic light exposure for 30 minutes each morning from the time of breast cancer surgery until the end of the chemotherapy treatment
Device: Light Glasses (Experimental)
The light glasses emit light from LEDs at a distance of 15 millimeters (15mm, 0.015.) from the eye. The device is classified as safe for the eyes in accordance with the international standard IEC 62471 and complies with the United States of America's FCC marking, and is designed to be worn on the participant's head, similar to a pair of glasses. For safety purposes, the light glasses do not contain UV or infra-red light.

Active Comparator: Comparison Light:Breast cancer surgery and chemotherapy
Exposed to comparison systematic light exposure for 30 minutes each morning from the time of breast cancer surgery until the end of the chemotherapy treatment
Device: Light Glasses (Comparison)
The light glasses emit light from LEDs at a distance of 15 millimeters (15mm, 0.015.) from the eye. The device is classified as safe for the eyes in accordance with the international standard IEC 62471 and complies with the United States of America's FCC marking, and is designed to be worn on the participant's head, similar to a pair of glasses. For safety purposes, the light glasses do not contain UV or infra-red light.

Experimental: Experimental light: Breast cancer surgery and no chemotherapy
Exposed to experimental systematic light exposure for 30 minutes each morning for four weeks starting at the time of breast cancer surgery
Device: Light Glasses (Experimental)
The light glasses emit light from LEDs at a distance of 15 millimeters (15mm, 0.015.) from the eye. The device is classified as safe for the eyes in accordance with the international standard IEC 62471 and complies with the United States of America's FCC marking, and is designed to be worn on the participant's head, similar to a pair of glasses. For safety purposes, the light glasses do not contain UV or infra-red light.

Active Comparator: Comparison light: Breast cancer surgery and no chemotherapy
Exposed to experimental systematic light exposure for 30 minutes each morning for four weeks starting at the time of breast cancer surgery
Device: Light Glasses (Comparison)
The light glasses emit light from LEDs at a distance of 15 millimeters (15mm, 0.015.) from the eye. The device is classified as safe for the eyes in accordance with the international standard IEC 62471 and complies with the United States of America's FCC marking, and is designed to be worn on the participant's head, similar to a pair of glasses. For safety purposes, the light glasses do not contain UV or infra-red light.




Primary Outcome Measures :
  1. FACIT-Fatigue Scale [ Time Frame: Up to 14 months ]
    The FACIT-Fatigue Scale is an outcome measure of fatigue consisting of 13 items on a four point Likert scale about fatigue levels during usual daily activities over the past 7 days. The scale has excellent test-retest reliability (r = 0.90) and internal consistency reliability (α= 0.93-0.95).

  2. Pittsburgh Sleep Quality Index [ Time Frame: Up to 14 months ]
    The Pittsburgh Sleep Quality Index assesses sleep quality. The scale consists of 19 self-rated items, divided into seven components. The scores ranges from 0-21, with lower scores indicating better sleep quality. The scale has the test-retest reliability of r=.85 and estimated internal consistency of α=.80.

  3. The Center for Epidemiological Studies Depression Scale [ Time Frame: Up to 14 months ]
    The Center for Epidemiological Studies Depression Scale (CES-D) measures depression symptoms. The 20 items scores range from 0 - 60, with higher scores indicating greater depressive symptoms. Internal consistency for women undergoing breast cancer treatment is estimated to be α=.89 and α=.90 for healthy comparison group.

  4. PROMIS cognitive function and cognitive abilities [ Time Frame: Up to 14 months ]
    PROMIS® (Patient-Reported Outcomes Measurement Information System) cognitive function and cognitive abilities 8a consist of 8 self-report item rated on a five point Likert scale ranging from "never" to "very often" on the Cognitive Function scale and "not at all" to "very much" on the Cognitive Abilities scale. Both PROMIS item banks show good psychometric properties, such as a high internal consistency (α =.94 for each).

  5. The Rey 15-Item Memory Test [ Time Frame: Up to 14 months ]
    The Rey 15-Item Memory Test evaluates short-term memory along with long-term memory. The test consists of series of 15 common words and the subject freely expressing the words retained. Afterward, another list of 15 unrelated words are given and the task of the subject is to repeat the original list of 15 words and then to repeat it after 30 minutes. RAVLT has good internal consistency (α=.80) and adequate convergent and divergent validity.

  6. The Digit Span test [ Time Frame: Up to 14 months ]
    The Digit Span test assesses working memory and immediate auditory recall. It is a part of the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV). The test has two subsections: Digits forwards and Digits backwards, each containing eight items. The task of the participants is to repeat the sequence of numbers the examiner reads for them, either repeat exactly what the examiner said or reverse it. Its reliability and validity is considered to be good, with internal consistency of 0.79, test-retest reliability of 0.77 and split-half reliability of 0.88.

  7. The Stroop task [ Time Frame: Up to 14 months ]
    The Stroop task assesses selective attention, or the ability of the participant to block out irrelevant stimuli. The first subtask consists of reading color names (yellow, red, green and blue) written in black ink as fast as possible, in order to measure the reading and psychomotor speed of the participants. The second subtask consists of naming colored pads and in the third subtask the participants say the font color in which the color names are written in, which do not necessarily match. Stroop has been found to be stable across the one- and two week period with a test-retest coefficient of 0.83 for the Word task, 0.74 for the Color task and 0.67 for the Color Word task.

  8. The Trail Making test [ Time Frame: Up to 14 months ]
    The Trail Making Test (TMT) consists of two parts: TMT A and B. TMT A measures visual search and psychomotor speed, whereas TMT B measures divided attention, cognitive flexibility and working memory. In TMT A, the task of the participants is to draw a line as quickly as they can between 25 circles in the correct order without lifting their pencil, with each circle containing a number from 1-25 presented in an random array. In TMT B, the task of the participants is to draw a line between randomly arranged encircled numbers from 1 to 13 and letters from A to L, in the correct sequence while alternating between letters and numbers, as quickly and accurately as they can. Test-retest reliability of 0.79 has been found for part A and 0.89 for part B.

  9. Psychomotor Vigilance task [ Time Frame: Up to 14 months ]
    Psychomotor vigilance task (PVT) measures alertness and vigilant attention and is considered to be the gold standard measure of neurobehavioral effects of circadian misalignment and sleep loss. In PVT participants are instructed to attend to a red rectangular box on a computer screen and to respond to a yellow stimulus counter inside the box. PVT gives information about accuracy and reaction time. The test has shown good psychometric properties, such as high reliability, with intra-class correlations assessing test-retest reliability above 0.8.

  10. The automated Operation Span task [ Time Frame: Up to 14 months ]
    The automated operation span task (aOSPAN) measures working memory span and consists of solving math operations while remembering a set of letters in the correct order, in set sizes ranging from 2 to 5. The task starts with three practice trials. The aOSPAN gives information about accuracy and reaction time. AOSPAN has shown to be reliable across sessions (.83) and to load highly on the working memory capacity factor (.68).

  11. The Word Fluency Test [ Time Frame: Up to 14 months ]
    The Word Fluency test measures executive functioning and semantic abilities of the participants. This test is the Icelandic equivalent of the standard F-A-S test, employing the letters H and S since they are the most frequent letters in Icelandic. The initial part of the test consists of phonemic fluency tasks where the participants say as many words beginning with the letter H as fast as they possibly can in one minute, followed by the letter S. The latter part of the test measures semantic fluency where the participants are instructed to do the same but with animal names. The test has shown good internal consistency (α=.83) and test-retest reliability of .74.


Secondary Outcome Measures :
  1. Salivary Cortisol [ Time Frame: Up to 14 months ]
    Salivary Cortisol: A commercial chemiluminescence immunoassay (CLIA) will be used to analyze the saliva samples, with a lower detection limit of 0.41 nmol/L. Inter- and intra-assay coefficients of variance are <10% across the expected range of cortisol levels. The following parameters will be calculated and used in analyses: 1) the cortisol awakening response (the rise in cortisol from waking to 30 minutes post-waking), 2) nocturnal cortisol, and 3) the diurnal cortisol slope.

  2. Urinary Melatonin [ Time Frame: Up to 14 months ]
    Production of pineal melatonin can be inferred from urinary 6 sulfatoxymelatonin (major metabolite of melatonin in urine). Urinary aMT6s (ng/mg Creatinine) will be measured by a competitive ELISA kit. Total excretion of aMT6s is calculated by multiplying the assayed concentration by the volume of urine voided. The aMT6s profiles will be analyzed using cosinor analysis, which is based on the least square approximation of the time series using a cosine function with a period of 24 h. The following parameters will be calculated: 1) acrophase time: time of the peak aMT6s concentration; 2) mesor: mean aMT6s value for all the samples included in the cosinor analysis and 3) amplitude: difference between the mesor and the peak aMT6s level.

  3. Circadian Activity Rhythms [ Time Frame: Up to 14 months ]
    Circadian Activity Rhythms (CAR) will be recorded with a wrist actigraphy or ActTrust. ActTrust generates the the following three CAR parameters: 1) Amplitude (peak or maximum of the curve, with a lower amplitude indicating a less rhythmic rhythm); 2) Acrophase (time of day of the peak activity, with a later time indicating more phase-delay); and 3) Mesor (half-way between minimum and maximum of the curve, a circadian rhythm-adjusted mean of the daily activity).

  4. Connor-Davidson Resilience Scale [ Time Frame: Up to 14 months ]
    Connor-Davidson Resilience Scale (CD-RISC-10) is a 10 item ordinal scale rated on a 5-point (0-4) scale with higher scores reflecting greater resilience. It is meant to measure one's ability to "bounce-back" and propensity for adaptability. The scale has excellent Internal Consistency, α=.85.

  5. Positive and Negative Affect Schedule [ Time Frame: Up to 14 months ]
    Positive and Negative Affect Schedule (I-PANAS-SF) shorter version is a self-report affect scale that measures positive and negative feelings on a 5-point Likert scale, consisting of five positive stated and five negative stated questions, in total 10 questions. The scale has good internal reliability, or α=.82.

  6. The Credibility/Expectation Questionnaire [ Time Frame: Up to 14 months ]
    The Credibility/Expectation Questionnaire (CEQ) consists of 5 items listed on a 10-point self-report scale that measures treatment credibility and expectancy in clinical outcome studies. The scale has high internal consistency within the two factors, credibility α=.81 and expectation α=.90, and good test-retest reliability.

  7. Godin-Shephard Leisure-Time Physical Activity Questionnaire [ Time Frame: Up to 14 months ]
    Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ)/Godin-Shephard Leisure-Time Exercise Questionnaire (GLTEQ) consists of three self-report questions were respondents rates their weekly leisure activity, such as how often and how strenuous they typically exercise. The leisure score index is obtained by the multiplying the frequency of each score with a corresponding Metabolic Equivalent of Task (MET) value, dividing the total score in three categories: active (24 units or more), moderately active (14 to 23 units) and less substantial or low benefits (14 units or less).

  8. The reduced Horne & Östberg Morningness-Eveningness Questionnaire [ Time Frame: Up to 14 months ]
    The reduced Horne & Östberg Morningness-Eveningness Questionnaire (rMEQ) is a self-report questionnaire consisting of 5 questions that assess chronotypes, where a higher score suggests a morningness chronotype. Its internal consistency has been estimated to be α=.69 - .78.

  9. Severity of cancer symptoms [ Time Frame: Up to 14 months ]
    MD Anderson Symptom Inventory (MDASI) is a symptom-specific patient-reported outcome instrument that consists of 19 questions developed to direct access symptoms experienced by cancer patients and how much they interfere with daily living. The inventory has a good internal consistency and test-retest reliability of α= ≥ .84 and intraclass correlation for all subscales ≥ .76.

  10. SF-12 [ Time Frame: Up to 14 months ]
    SF-12 consists of 12 items that measure health related quality of life, both physical and mental wellbeing, and is the shorter form of the SF-36 questionnaire. A study among breast cancer survivors found an internal consistency of α > .85.

  11. The Life Events Checklist [ Time Frame: Up to 14 months ]
    The Life Events Checklist (LEC) assesses exposure to 16 potentially traumatic events known to predict posttraumatic stress disorder or other posttraumatic difficulties. For each item, participants are asked whether the trauma exposure was direct or indirect. Its psychometric properties have proven decent, with good temporal stability and convergence with other established trauma history measures.

  12. FACIT-TS-G [ Time Frame: Up to 14 months ]
    FACIT-TS-G assesses how satisfied participants are with the treatment they received. In the current study we use 10 questions adapted to the Bright Light therapy, e.g. about potential side effects.

  13. Hot Flashes [ Time Frame: Up to 14 months ]
    In the current study we employ the Daily Patient questionnaire about Hot Flashes for female patients. The questionnaire consists of examples of how cancer patients in previous studies have defined symptoms of their hot flashes as mild, moderate, severe and very severe. The participants fill out a diary for a week, consisting of the number of hot flashes along with their severity for each day.

  14. The Impact of Event Scale [ Time Frame: Up to 14 months ]
    The Impact of Event Scale measures trauma related stress, that is cancer specific distress. It is a 22-item scale, divided up into three subscales; intrusion, avoidance and hyperarousal. Total scores range from 0-88, with higher scores suggesting more distress. High levels of internal consistency have been previously reported (Intrusion: α=.87 - 0.92, Avoidance: α=.84 - .85, Hyperarousal: α= .79 - .90). Test-retest correlation coefficients were reported moderate to high (Intrusion: .57 - .94, Avoidance: .51 - .89, Hyperarousal: .59 - .92).

  15. The NCCN Distress Thermometer [ Time Frame: Up to 14 months ]
    The NCCN Distress Thermometer and checklist is a widely used screening measure for distress in cancer patients. It consists of a distress thermometer where participants assess their distress on a scale from 0 to 10, were 0 indicates no distress and 10 extreme distress. Additionally, participants answer a problem checklist with several domains to identify what area of life distresses the participant.

  16. The Social Constraints Scale [ Time Frame: Up to 14 months ]
    The Social Constraints Scale (SCS) shorter version consists of 6 items, scored from "never" to "always" on a 4-point Likert scale. Social constraints assesses the perceived lack of social support from someone close to them, discouraging the cancer patient to express their cancer-related-emotions. The internal consistency of the scale has been shown to be adequate (α=.71 - .81).

  17. Short Form of the Post-Traumatic Growth Inventory [ Time Frame: Up to 14 months ]
    Short Form of the Post-Traumatic Growth Inventory (PTGI-SF) is a 10-item ordinal scale used to assess positive outcomes after a traumatic event. The scale has excellent internal consistency (α=.86) and appears to have utility in determining how successful individuals are in reconstructing or strengthening their perceptions of self, others, and the meaning of events.

  18. The Generalized Anxiety Disorder [ Time Frame: Up to 14 months ]
    The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item measure used to screen for general anxiety disorder and its severity. The scale is on 4-point Likert scale ("not at all" to "several days") and the score ranges from 0-21, with higher scores indicating more severe anxiety. Its internal consistency is estimated excellent (α=.92).

  19. The Perceived Stress Scale [ Time Frame: Up to 14 months ]
    The Perceived Stress Scale (PSS-10) is a 10-item scale used to measure stress. Each item on the list is rated on a 5-point Likert scale ranging from "never" to "very often". PSS-10 total score ranges from 0 to to 40, where a higher score indicates higher perceived stress. The scale has adequate reliability and validity.

  20. Functional Assessment of Cancer Therapy-Breast [ Time Frame: Up to 14 months ]
    Functional Assessment of Cancer Therapy-Breast version 4 (FACT-B v4) measures the multidimensional quality of life in breast cancer patients. The instrument consists of five subscales with 37 breast cancer-specific items. The scale demonstrates a good reliability, validity and internal consistency (α ≥ .70).

  21. Sleep/wake activity [ Time Frame: Up to 14 months ]
    Sleep/wake activity will be recorded with a wrist actigraphy or ActTrust. ActTrust actigraph generates the following seep/wake information: Percent sleep, number of awakenings per night, length of awakenings at night, percent wake, and napping behavior (number of naps defined as 10 minutes of inactivity; naptime).

  22. Circadian Activity Rhythms - Amplitude [ Time Frame: Up to 14 months ]
    Circadian Activity Rhythms (CAR) will be recorded with a wrist actigraphy or ActTrust. ActTrust generates amplitude (peak or maximum of the curve, with a lower amplitude indicating a less rhythmic rhythm).

  23. Circadian Activity Rhythms - Acrophase [ Time Frame: Up to 14 months ]
    Circadian Activity Rhythms (CAR) will be recorded with a wrist actigraphy or ActTrust. ActTrust generates acrophase (time of day of the peak activity, with a later time indicating more phase-delay).

  24. Circadian Activity Rhythms - Mesor [ Time Frame: Up to 14 months ]
    Circadian Activity Rhythms (CAR) will be recorded with a wrist actigraphy or ActTrust. ActTrust generates mesor (half-way between minimum and maximum of the curve, a circadian rhythm-adjusted mean of the daily activity).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed patients with stages 1 to 3 breast cancer scheduled to undergo surgery (without chemotherapy) and newly diagnosed patients with stages 1 to 3 breast cancer scheduled to undergo both surgery and chemotherapy.

Exclusion Criteria:

  • Stage 3B breast cancer, inflammatory or stage 4 breast cancer; under age 18; pregnancy; pre-existing anemia (Hb <10gm/dl); history of bipolar disorder or mania (which are contra-indications for BWL treatment); and any other physical or psychological impairments (e.g., sleep disorder diagnosis) which could limit participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04418856


Contacts
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Contact: Snaefridur Gudmundsdottir Aspelund, MSc +3546626279 snaefridur19@ru.is
Contact: Huldis Franksdottir Daly, MSc huldis11@ru.is

Locations
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Iceland
Reykjavik University Recruiting
Reykjavik, Iceland, 102
Contact: Snæfríður G Aspelund, MSc         
Sponsors and Collaborators
Reykjavik University
The Icelandic Centre for Research
Investigators
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Principal Investigator: Heiddis Valdimarsdottir, PhD Reykjavik University
Study Director: Birna Baldursdottir, PhD Reykjavik University
Publications:
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Responsible Party: Dr. Heiddis B Valdimarsdottir, Professor, Reykjavik University
ClinicalTrials.gov Identifier: NCT04418856    
Other Study ID Numbers: VSN-18-199
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Heiddis B Valdimarsdottir, Reykjavik University:
Breast cancer
Light therapy
Cancer related side effects
Circadian rhythms
Inflammatory markers
Additional relevant MeSH terms:
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Breast Neoplasms
Dyssomnias
Parasomnias
Fatigue
Depression
Cognitive Dysfunction
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Mental Disorders
Cognition Disorders
Neurocognitive Disorders
Sleep Wake Disorders
Nervous System Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors