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

NCT ID: NCT04418856

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-08
• Study Completion Date: 2024-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Light Glasses (Experimental)

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Light Glasses (Comparison)

Intervention Type: 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 no chemotherapy

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

Group Type: EXPERIMENTAL

Light Glasses (Experimental)

Intervention Type: 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 no chemotherapy

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

Group Type: ACTIVE_COMPARATOR

Light Glasses (Comparison)

Intervention Type: 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.

Healthy control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Icelandic Research Fund

UNKNOWN

Sponsor Role: collaborator

Reykjavik University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Heiddis B Valdimarsdottir

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heiddis Valdimarsdottir, PhD

Role: PRINCIPAL_INVESTIGATOR

Reykjavik University

Birna Baldursdottir, PhD

Role: STUDY_CHAIR

Reykjavik University

Hannah R Sigurdardottir Tobin, MSc

Role: STUDY_DIRECTOR

University of Reykjavík

Locations

Reykjavik University

Reykjavik, , Iceland

Site Status: RECRUITING

Countries

Iceland

Central Contacts

Hannah R Sigurdardottir Tobin, MSc

Role: CONTACT

hannahs@ru.is

+3548659910

Birna Baldursdottir, PhD

Role: CONTACT

birnabaldurs@ru.is

+3548608108

Facility Contacts

Snæfríður G Aspelund, MSc

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 16010529 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18258985 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24183157 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29198295 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38185720 (View on PubMed)

Other Identifiers

VSN-18-199

Identifier Type: -

Identifier Source: org_study_id