Clinical trial NCT04418856: The Effects of Light Therapy to Treat Cancer-related Side Effects
Official title: Light Therapy to Treat Cancer-related Fatigue, Sleep Problems, Depression and Cognitive Impairment Among Breast Cancer Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Reykjavik University
Sponsor class: OTHER
Collaborators: name: The Icelandic Research Fund
First posted: 2020-06-05
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Healthy controls: never received a cancer diagnosis

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.

Primary outcomes:
measure: FACIT-Fatigue Scale
timeFrame: Up to 14 months
measure: Pittsburgh Sleep Quality Index
timeFrame: Up to 14 months
measure: The Center for Epidemiological Studies Depression Scale
timeFrame: Up to 14 months
measure: PROMIS cognitive function and cognitive abilities
timeFrame: Up to 14 months
measure: The Rey 15-Item Memory Test
timeFrame: Up to 14 months
measure: The Digit Span test
timeFrame: Up to 14 months
measure: The Stroop task
timeFrame: Up to 14 months
measure: The Trail Making test
timeFrame: Up to 14 months
measure: Psychomotor Vigilance task
timeFrame: Up to 14 months
measure: The automated Operation Span task
timeFrame: Up to 14 months
measure: The Word Fluency Test
timeFrame: Up to 14 months
Secondary outcomes:
measure: Salivary Cortisol
timeFrame: Up to 14 months
measure: Urinary Melatonin
timeFrame: Up to 14 months
measure: Circadian Activity Rhythms
timeFrame: Up to 14 months
measure: Connor-Davidson Resilience Scale
timeFrame: Up to 14 months
measure: Positive and Negative Affect Schedule
timeFrame: Up to 14 months
measure: The Credibility/Expectation Questionnaire
timeFrame: Up to 14 months
measure: Godin-Shephard Leisure-Time Physical Activity Questionnaire
timeFrame: Up to 14 months
measure: The reduced Horne & Östberg Morningness-Eveningness Questionnaire
timeFrame: Up to 14 months
measure: Severity of cancer symptoms
timeFrame: Up to 14 months
measure: SF-12
timeFrame: Up to 14 months
measure: The Life Events Checklist
timeFrame: Up to 14 months
measure: FACIT-TS-G
timeFrame: Up to 14 months
measure: Hot Flashes
timeFrame: Up to 14 months
measure: The Impact of Event Scale
timeFrame: Up to 14 months
measure: The NCCN Distress Thermometer
timeFrame: Up to 14 months
measure: The Social Constraints Scale
timeFrame: Up to 14 months
measure: Short Form of the Post-Traumatic Growth Inventory
timeFrame: Up to 14 months
measure: The Generalized Anxiety Disorder
timeFrame: Up to 14 months
measure: The Perceived Stress Scale
timeFrame: Up to 14 months
measure: Functional Assessment of Cancer Therapy-Breast
timeFrame: Up to 14 months
measure: Sleep/wake activity
timeFrame: Up to 14 months
measure: Circadian Activity Rhythms - Amplitude
timeFrame: Up to 14 months
measure: Circadian Activity Rhythms - Acrophase
timeFrame: Up to 14 months
measure: Circadian Activity Rhythms - Mesor
timeFrame: Up to 14 months
Other outcomes:
Locations:
city: Reykjavik
country: Iceland
facility: Reykjavik University
Study officials:
affiliation: Reykjavik University
name: Heiddis Valdimarsdottir, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Reykjavik University
name: Birna Baldursdottir, PhD
role: STUDY_CHAIR
affiliation: University of Reykjavík
name: Hannah R Sigurdardottir Tobin, MSc
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.