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

Reykjavik University

Status: Enrolling

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

Treatments: Device: Light Glasses (Comparison); Device: Light Glasses (Experimental)

Study type: Interventional

Funder types: Other

Identifiers

NCT04418856

VSN-18-199

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 5 patient groups

Experimental light: Breast cancer surgery and chemotherapy

Experimental group

Description:

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

Treatment:

Device: Light Glasses (Experimental)

Comparison Light:Breast cancer surgery and chemotherapy

Active Comparator group

Description:

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

Treatment:

Device: Light Glasses (Comparison)

Experimental light: Breast cancer surgery and no chemotherapy

Experimental group

Description:

Exposed to experimental systematic light exposure for 30 minutes each morning for four weeks starting at the time of breast cancer surgery

Treatment:

Device: Light Glasses (Experimental)

Comparison light: Breast cancer surgery and no chemotherapy

Active Comparator group

Description:

Exposed to experimental systematic light exposure for 30 minutes each morning for four weeks starting at the time of breast cancer surgery

Treatment:

Device: Light Glasses (Comparison)

Healthy control group

No Intervention group

Description:

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