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

NCT04418856 | Recruiting

• 1 other identifier: VSN-18-199
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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, compared to healthy controls. 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.

Conditions

Breast Cancer; Circadian Rhythms; Fatigue; Sleep Disturbance; Cognitive Impairment; Inflammatory Response; Depression

Keywords

Breast cancer; Light therapy; Cancer related side effects; Circadian rhythms; Inflammatory markers

Outcome Measures

Primary Outcomes (11)

• FACIT-Fatigue Scale

  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).

  Up to 14 months

• Pittsburgh Sleep Quality Index

  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.

  Up to 14 months

• The Center for Epidemiological Studies Depression Scale

  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.

  Up to 14 months

• PROMIS cognitive function and cognitive abilities

  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).

  Up to 14 months

• The Rey 15-Item Memory Test

  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.

  Up to 14 months

• The Digit Span test

  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.

  Up to 14 months

• The Stroop task

  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.

  Up to 14 months

• The Trail Making test

  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.

  Up to 14 months

• Psychomotor Vigilance task

  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.

  Up to 14 months

• The automated Operation Span task

  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).

  Up to 14 months

• The Word Fluency Test

  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.

  Up to 14 months

Secondary Outcomes (24)

• Salivary Cortisol

  Up to 14 months

• Urinary Melatonin

  Up to 14 months

• Circadian Activity Rhythms

  Up to 14 months

• Connor-Davidson Resilience Scale

  Up to 14 months

• Positive and Negative Affect Schedule

  Up to 14 months

Study Arms (5)

Experimental light: Breast cancer surgery and chemotherapy

EXPERIMENTAL

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)

Comparison Light:Breast cancer surgery and chemotherapy

ACTIVE COMPARATOR

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)

Experimental light: Breast cancer surgery and no chemotherapy

EXPERIMENTAL

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)

Comparison light: Breast cancer surgery and no chemotherapy

ACTIVE COMPARATOR

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)

Healthy control group

NO INTERVENTION

The healthy control group and the breast cancer patients undergo the same assessments (questionnaires, neuropsychological assessments and actigraphy) at the same time points

Interventions

Light Glasses (Experimental) DEVICE

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 light: Breast cancer surgery and chemotherapy; Experimental light: Breast cancer surgery and no chemotherapy

Light Glasses (Comparison) DEVICE

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.

Comparison Light:Breast cancer surgery and chemotherapy; Comparison light: Breast cancer surgery and no chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer Patients: 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.
• Healthy controls: never received a cancer diagnosis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reykjavik University: lead
• The Icelandic Research Fund: collaborator

Study Sites (1)

Reykjavik University

Reykjavik, 102, Iceland

RECRUITING

Related Publications (6)

• Ancoli-Israel S, Liu L, Marler MR, Parker BA, Jones V, Sadler GR, Dimsdale J, Cohen-Zion M, Fiorentino L. Fatigue, sleep, and circadian rhythms prior to chemotherapy for breast cancer. Support Care Cancer. 2006 Mar;14(3):201-9. doi: 10.1007/s00520-005-0861-0. Epub 2005 Jul 12.

  PMID: 16010529 BACKGROUND

• Bower JE. Behavioral symptoms in patients with breast cancer and survivors. J Clin Oncol. 2008 Feb 10;26(5):768-77. doi: 10.1200/JCO.2007.14.3248.

  PMID: 18258985 BACKGROUND

• Merriman JD, Von Ah D, Miaskowski C, Aouizerat BE. Proposed mechanisms for cancer- and treatment-related cognitive changes. Semin Oncol Nurs. 2013 Nov;29(4):260-9. doi: 10.1016/j.soncn.2013.08.006.

  PMID: 24183157 BACKGROUND

• Wu LM, Amidi A, Valdimarsdottir H, Ancoli-Israel S, Liu L, Winkel G, Byrne EE, Sefair AV, Vega A, Bovbjerg K, Redd WH. The Effect of Systematic Light Exposure on Sleep in a Mixed Group of Fatigued Cancer Survivors. J Clin Sleep Med. 2018 Jan 15;14(1):31-39. doi: 10.5664/jcsm.6874.

  PMID: 29198295 BACKGROUND

• Aspelund SG, Halldorsdottir T, Agustsson G, Tobin HRS, Wu LM, Amidi A, Johannsdottir KR, Lutgendorf SK, Telles R, Daly HF, Sigurdardottir K, Figueiro MG, Redd WH, Valdimarsdottir HB, Baldursdottir B. The Effects of Light Therapy on Cognitive Function and Stress in Women With Breast Cancer Before Systemic Treatment. Cancer Med. 2025 Nov;14(22):e71412. doi: 10.1002/cam4.71412.

  PMID: 41275449 DERIVED

• Aspelund SG, Halldorsdottir T, Agustsson G, Sigurdardottir Tobin HR, Wu LM, Amidi A, Johannsdottir KR, Lutgendorf SK, Telles R, Daly HF, Sigurdardottir K, Valdimarsdottir HB, Baldursdottir B. Biological and psychological predictors of cognitive function in breast cancer patients before surgery. Support Care Cancer. 2024 Jan 8;32(1):88. doi: 10.1007/s00520-023-08282-5.

  PMID: 38185720 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Fatigue; Parasomnias; Cognitive Dysfunction; Depression

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Behavioral Symptoms; Behavior

Study Officials

• Heiddis Valdimarsdottir, PhD

  Reykjavik University

  PRINCIPAL INVESTIGATOR

• Birna Baldursdottir, PhD

  Reykjavik University

  STUDY CHAIR

• Hannah R Sigurdardottir Tobin, MSc

  University of Reykjavík

  STUDY DIRECTOR

Central Study Contacts

Hannah R Sigurdardottir Tobin, MSc

CONTACT

+3548659910; hannahs@ru.is

Birna Baldursdottir, PhD

CONTACT

+3548608108; birnabaldurs@ru.is

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: June 5, 2020
• Study Start: June 8, 2020
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)