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Breast CancerNCT04418856

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

A study testing Light Glasses (Experimental) and Light Glasses (Comparison) in people with Breast Cancer and Circadian Rhythms, run by Reykjavik University at 1 site in Iceland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer, Circadian Rhythms, Fatigue
What is being tested?
Light Glasses (Experimental) and Light Glasses (Comparison)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
1 siteIceland
Study dates
8 Jun 2020to 17 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Iceland1 site

  • Reykjavik University

    Reykjavik, 102

Other trials in Iceland

About this study

Official title: Light Therapy to Treat Cancer-related Fatigue, Sleep Problems, Depression and Cognitive Impairment Among Breast Cancer Patients.

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.

Read more

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.

Being tested
Light Glasses (Experimental), Light Glasses (Comparison)
Keywords
Breast cancer, Light therapy, Cancer related side effects, Circadian rhythms, Inflammatory markers
Medical subject headings
Breast Neoplasms, Fatigue, Parasomnias, Cognitive Dysfunction, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT04418856
Study groupRoleWhat they receive
Experimental light: Breast cancer surgery and chemotherapyExperimentalExposed to experimental systematic light exposure for 30 minutes each morning from the time of breast cancer surgery until the end of the chemotherapy treatment
Receives: Device: Light Glasses (Experimental)
Comparison Light:Breast cancer surgery and chemotherapyActive comparatorExposed to comparison systematic light exposure for 30 minutes each morning from the time of breast cancer surgery until the end of the chemotherapy treatment
Receives: Device: Light Glasses (Comparison)
Experimental light: Breast cancer surgery and no chemotherapyExperimentalExposed to experimental systematic light exposure for 30 minutes each morning for four weeks starting at the time of breast cancer surgery
Receives: Device: Light Glasses (Experimental)
Comparison light: Breast cancer surgery and no chemotherapyActive comparatorExposed to experimental systematic light exposure for 30 minutes each morning for four weeks starting at the time of breast cancer surgery
Receives: Device: Light Glasses (Comparison)
Healthy control groupNo interventionThe healthy control group and the breast cancer patients undergo the same assessments (questionnaires, neuropsychological assessments and actigraphy) at the same time points

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Up to 14 months

  2. 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.

    Measured: Up to 14 months

  3. 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.

    Measured: Up to 14 months

  4. 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).

    Measured: Up to 14 months

  5. 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.

    Measured: Up to 14 months

  6. 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.

    Measured: Up to 14 months

  7. 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.

    Measured: Up to 14 months

  8. 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.

    Measured: Up to 14 months

  9. 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.

    Measured: Up to 14 months

  10. 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).

    Measured: Up to 14 months

  11. 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.

    Measured: Up to 14 months

Secondary outcomes (24)

  1. Salivary Cortisol

    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.

    Measured: Up to 14 months

  2. Urinary Melatonin

    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.

    Measured: Up to 14 months

  3. Circadian Activity Rhythms

    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).

    Measured: Up to 14 months

  4. Connor-Davidson Resilience Scale

    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.

    Measured: Up to 14 months

  5. Positive and Negative Affect Schedule

    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.

    Measured: Up to 14 months

  6. The Credibility/Expectation Questionnaire

    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.

    Measured: Up to 14 months

  7. Godin-Shephard Leisure-Time Physical Activity Questionnaire

    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).

    Measured: Up to 14 months

  8. The reduced Horne & Östberg Morningness-Eveningness Questionnaire

    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.

    Measured: Up to 14 months

  9. Severity of cancer symptoms

    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.

    Measured: Up to 14 months

  10. SF-12

    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.

    Measured: Up to 14 months

  11. The Life Events Checklist

    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.

    Measured: Up to 14 months

  12. FACIT-TS-G

    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.

    Measured: Up to 14 months

  13. Hot Flashes

    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.

    Measured: Up to 14 months

  14. The Impact of Event Scale

    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).

    Measured: Up to 14 months

  15. The NCCN Distress Thermometer

    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.

    Measured: Up to 14 months

  16. The Social Constraints Scale

    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).

    Measured: Up to 14 months

  17. Short Form of the Post-Traumatic Growth Inventory

    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.

    Measured: Up to 14 months

  18. The Generalized Anxiety Disorder

    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).

    Measured: Up to 14 months

  19. The Perceived Stress Scale

    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.

    Measured: Up to 14 months

  20. Functional Assessment of Cancer Therapy-Breast

    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).

    Measured: Up to 14 months

  21. Sleep/wake activity

    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).

    Measured: Up to 14 months

  22. Circadian Activity Rhythms - Amplitude

    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).

    Measured: Up to 14 months

  23. Circadian Activity Rhythms - Acrophase

    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).

    Measured: Up to 14 months

  24. Circadian Activity Rhythms - Mesor

    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).

    Measured: Up to 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2020
  2. Study start8 Jun 2020
  3. Primary completion11 Sep 2024
  4. Study completion17 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04418856
Sponsor's protocol ID
VSN-18-199
Status last verified
May 2026
First submitted
5 May 2020
Last updated
2 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16010529

  • 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.

    PubMed 18258985

  • 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.

    PubMed 24183157

  • 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.

    PubMed 29198295

  • 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.

    PubMed 41275449

  • 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.

    PubMed 38185720

Questions about this trial

What is this clinical trial studying?

A study testing Light Glasses (Experimental) and Light Glasses (Comparison) in people with Breast Cancer and Circadian Rhythms, run by Reykjavik University at 1 site in Iceland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FACIT-Fatigue Scale (time frame: Up to 14 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04418856, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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