Behaviors and Mental Disorders

All Conditions

Symptoms and General Pathology

Neoplasms

Skin and Connective Tissue Diseases

Nervous System Diseases

Depressive Disorder

Fatigue

Breast Neoplasms

Parasomnias

Depression

Cognitive Dysfunction

Dyssomnias

Breast Diseases

Skin Diseases

Behavioral Symptoms

Mental Disorders

Psychotic Disorders

Cognition Disorders

Neurocognitive Disorders

Central Nervous System Stimulants

All Drugs and Chemicals

Cardiotonic Agents

Methamphetamine

Sympathomimetics

Dopamine

Dopamine Agents

Neurotransmitter Agents

Adrenergic Agents

Dopamine Uptake Inhibitors

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

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

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

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

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 (Experimental)

Light Glasses (Comparison)

Hannah R Sigurdardottir Tobin, MSc

Birna Baldursdottir, PhD

Snæfríður G Aspelund, MSc

Heiddis Valdimarsdottir, PhD

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.

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

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

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).

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.

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.

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).

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.

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.

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.

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.

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.

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).

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.

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.

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.

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).

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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).

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.

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).

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.

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).

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.

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).

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).

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).

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).

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).

The Icelandic Research Fund

Reykjavik University

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Prostatic Neoplasms

Hematologic Neoplasms

Hematologic Diseases

Light intervention delivered through SYNC app + blue-light blocking glasses.

Placebo light intervention delivered through SYNC app + clear glasses.

Patient is given a wearable device to wear for 12 weeks.

Wearable Sensor

Patient is given blue-blocking glasses to wear at instructed times.

Blue-blocking glasses

Patient is given glasses that block no visible light.

Clear glasses

Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock.

Full SYNC app

Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock.

"Dummy" SYNC app

Sung Choi, MD

Fatigue is a major problem for cancer patients, and one that can persist long after treatment ends. Recent work has demonstrated that light therapy may mitigate or reduce fatigue levels in both cancer patients and cancer survivors. This protocol seeks to assess how lighting interventions distributed through a mobile app affect fatigue, sleep, and quality of life across three populations of cancer patients: breast cancer and prostate cancer, and patients who have undergone autologous hematopoietic stem cell transplant (HSCT). Participants will be randomized 1:1 to either the interventional SYNC app or to a control app.

Blocked randomization will be used to limit bias and achieve an equal distribution of participants to the intervention and control arms of the study (69 control, 69 intervention; with 23 from each cancer population in each arm). This approach will recruit participants in small blocks to ensure that half of the participants within each block will be allocated to the treatment and the other half to the control.

Lighting Intervention for Cancer-related Fatigue

A Randomized Trial Of The SYNC APP

The change from baseline in PROMIS 4-item Fatigue scores will enable the investigators to quantify the effects of the light interventions delivered by SYNC on patient fatigue. The final fatigue score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10 points. The average change in PROMIS fatigue T scores will be calculated for each arm. A negative change (lower scores) represents improvement in symptoms; a positive change (higher scores) represents worsening of symptoms. The study will have power of 0.80, assuming a two-sided Type I error rate of 0.05, to detect an effect size of half the standard deviation between the intervention and control arms if the accrual goal is reached.

8-item PROMIS sleep disturbance questionnaire completed on the first day and last day of the patient's time on study. Each item is on a scale of 1 - 5, best (1) to worst (5).

7-item PROMIS anxiety questionnaire completed on the first day and last day of the patient's time on study. Each item is on a scale of 1 - 5, best (1) to worst (5).

8-item PROMIS depression questionnaire completed on the first day and last day of the patient's time on study. Each item is on a scale of 1 - 5, best (1) to worst (5).

8-item PROMIS physical function questionnaire completed on the first day and last day of the patient's time on study. Each item is on a scale of 1 - 5, best (1) to worst (5).

PROMIS Global-10 is a 10-question survey used as an overall evaluation of one's physical and mental health. Raw scores are converted to T-scores. Higher scores reflect better functioning.

Arcascope, Inc

National Cancer Institute (NCI)

University of Michigan Rogel Cancer Center

Light therapy takes place in the patient's home the day following receipt of the equipment and for at least 7 days before the start of chemotherapy and according to current recommendations: daily exposure to a high intensity light (10,000 lux) in the morning at a time to be adapted to the patient according to his chronotype), for 30 minutes. Light therapy begins immediately after receipt of the luminometer. The total duration of daily outpatient therapy program is 6 months. A set of questionnaires evaluation of fatigue and quality of life will be given to the patient at the inclusion visit and at weeks 12 and 24. They will complete the same day or the day before, and / or before any chemotherapy. A follow-up visit will be performed 1 month after the end of therapy (week 28).

usual care in oncology: The patient will be taken care of according to local chemotherapy in routine care and the recommendations. A set of questionnaires evaluation of fatigue and quality of life will be given to the patient at baseline and at weeks 12 and 24. They will complete the same day or the day before, and / or chemotherapy before . A follow-up visit will be performed 1 month after the last visit (week 28). A set of questionnaires evaluation of fatigue and quality of life will be given to the patient and will complete the same day or the day before

The light therapy, 6 month's program, is occurring at patient's home the day after device's reception and during at least 7 days before chemotherapy's beginning. The ambulatory light program is daily exposure to a high-intensity light (10,000 lux) in the morning, at a time adapted to the patient according to his chronotype for 30 minutes. The light source should be placed at eye level (distance of about 40 cm). A set of questionnaires evaluation of fatigue and quality of life will be given to the patient at baseline and at weeks 12 and 24, which will be completed the same day or the day before, and / or before any chemotherapy. These questionnaires will be also completed during the follow-up visit 1 month after the last visit (week 28).

light therapy

The patient will be taken care of according to local chemotherapy in routine care and the recommendations. A set of questionnaires evaluation of fatigue and quality of life will be given to the patient at baseline and at weeks 12 and 24. They will complete the same day or the day before, and / or chemotherapy before. A follow-up visit will be performed 1 month after the last visit (week 28). A set of questionnaires evaluation of fatigue and quality of life will be given to the patient and will complete the same day or the day before.

Usual care

Fatigue is a symptom most commonly associated with the diagnosis of cancer. Fatigue often appears before the diagnosis of cancer, is increasing during treatment with chemotherapy and persists for years after treatment in more than 35% of patients. Fatigue is the earliest and most important symptom described by cancer patients. Its prevalence in cancer chemotherapy patients is between 70 and 100%. Fatigue is more common to cancer patients and to the general population or other types of patients. Typically described as a lack of energy associated with mental disorders, fatigue related to cancer can be extremely debilitating. The causes are many, mainly including the cancer itself, side effects due to treatment, sleeplessness due to pain, anxiety or depression. The cancer-related fatigue has a negative and significant direct impact on all aspects of the patient's quality of life, especially the physical, social and behavioral. Despite the availability of certain treatments and the advanced biomedical research, fatigue remains an inevitable consequence of cancer and its treatment.

The therapeutic use of natural light in medicine dates back to the late nineteenth century. Its remarkable effect on the stimulation of the immune system and fight against infections caused the development of the first therapy techniques (also called luxthérapie) awarded in 1903 by the Nobel Prize in medicine and physiology. Light plays a fundamental role in the regulation of circadian rhythms and homeostatic. The mechanism of action passes through a path "non-visual" involving melanopsin ganglion cells located in the retina. Activation of the pineal gland (epiphysis) by melanopsin cells allows transduce information "shadow and light" in melatonin synthesis from serotonin. Today, the effectiveness of the therapy is well established for treating fatigue-related disorders such as chronic fatigue, seasonal depression or seasonal or non-certain sleep disorders and in which the melatonin metabolism is disturbed. Light therapy, by its mechanism of action, allows reprogramming "of the biological clock and improved synchronization of circadian rhythms.

Hypotheses

Some studies have shown an inverse relationship between cancer-related fatigue and the time of exposure to natural light for cancer patients. This association suggests the existence of a vicious circle of side effects of chemotherapy (physical fatigue and moral), itself causing a decrease in outdoor activity and therefore a reduction of the light exposure time natural. This results in a strengthening of the initial patient's state of fatigue. In an interesting way, vitamin D synthesized in large part due to light plays a cancer protective role\], especially in the prevention and treatment of pancreatic cancer for example. Furthermore and paradoxical way, the disruption of circadian rhythms is correlated to the development and tumor progression in vitro, in vivo tumor growth and incidence of cancer in humans.

Notoriously, the direct effect of light therapy on cancer-related fatigue has been little discussed in the literature. Data obtained from a small sample of patients indicate that light therapy improves quality of life by reducing fatigue in patients with breast cancer during chemotherapy. To date, There are no data on the effects of light therapy on cancer-related fatigue in general, patients treated with chemotherapy.

The purpose of this pilot study is to evaluate the role of light therapy on cancer-related fatigue in patients during the 6 months following initiation of first-line chemotherapy.

Primary objective

To assess the effects of daily therapy on fatigue of patients with locally advanced or metastatic cancer treated with chemotherapy.

secondary objective

Evaluate the impact of daily light therapy on quality of life, pain, anxiety and depression, tolerance of chemotherapy and medico-economic benefits.

Effect on Fatigue of Light (Lux) Therapy in Patients With Cancer

Tiredness: PIPER Score (main variable) (22 items targeted in 4 dimensions: behavioral tiredness / intensity, emotional, sensory and cognitive / mood)

Quality of life related to health: EORTC-QLQ-C30 (30 items targeted in 4 dimensions: the overall quality of life, fatigue, physical functioning and pain).

Pain: BPI-Short Form (BPI-SF) and analgesic consumption

Depression / Anxiety: scale of depression and anxiety (HADS)

Fondation Hôpital Saint-Joseph

Substance Related Disorders

Immune System Diseases

Syndrome

Hand-Foot Syndrome

Exanthema

Drug Eruptions

Dermatitis

Hypersensitivity

Drug Hypersensitivity

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

The experimental group receives 9 sessions of photobiomodulation therapy (3x/week for 3 weeks).

Patients will receive PBM on the sole of their feet and palms of their hands

Photobiomodulation therapy (PBMT)

Jeroen Mebis, MD, PhD

Jolien Robijns, PhD

Hand-foot syndrome (HFS) is a side effect of chemotherapy. HFS is characterized by redness, swelling, and pain on the palms of the hands and/or soles of the feet, which can progress to blistering. Hand-foot skin reaction (HFSR) refers to symptoms affecting the hands and/or feet associated with multikinase inhibitors (TKIs). HFS and HFSR are painful complications that can lead to compromised daily activities, sleep-wake disturbance and impaired mobility, eventually decreasing Quality of Life (QoL).

Photobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and/or near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. The aim of this study is to evaluate the effectiveness of PBMT in the management of HFS and HFSR.

The aim of this study is to evaluate the efficacy of PBMT in the management of HFS and HFSR in patients with cancer treated with chemotherapy or TKIs up to 2 weeks post-PBMT.

Primary objective: The study seeks primarily to determine the effectiveness of PBMT in reducing the severity of HFS and HFSR in patients with cancer of different etiology undergoing chemotherapy or TKIs, diagnosed with HFS or HFSR (grade 1-3).

Secondary objective 1 : HFS/HFSR-related symptoms

A secondary aim of this study is to evaluate if PBMT and can reduce the HFS/HSFR-related symptoms during PBM treatment and up to 2 weeks post-PBMT

Secondary Objective 2: Quality of life

A secondary aim of this study is to evaluate if PBMT can improve the patients' QoL during PBM treatment and up to 2 weeks post-PBMT

Secondary Objective 3: Patient satisfaction

A secondary aim of this study is to evaluate if patients are satisfied with PBMT as a treatment for HFS and HFSR during the treatment sessions and up to 2 weeks post-PBMT

Secondary Objective 4: PBM safety

A secondary aim of this study is to evaluate the safety of PBM in oncologic patients up to 5 years post-PBMT.

Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction

Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction: A Single-arm Trial

General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (i.e., gender, age, smoking history, work habits, physical activity, skin condition, alcohol use, and medication use). Furthermore, information about disease- and treatment-related risk factors will be collected through medical records (e.g., tumor type and stage, tumor site, treatment type, etc).

The possible appearance and date of local and/or regional recurrence will be collected.

The possible appearance and date of secondary tumors will be collected.

The possible appearance and date of distant metastasis will be collected.

If the patient dies within the first year after the treatment, their date of death will be collected.

If the patient dies within 2 years after the treatment, their date of death will be collected.

If the patient dies within 3 years after the treatment, their date of death will be collected.

If the patient dies within 4 years after the treatment, their date of death will be collected.

If the patient dies within 5 years after the treatment, their date of death will be collected.

The severity of the skin reactions will be evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5.

The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR

A clinical photograph of the palm of patients' hands and sole of their feet

The patients will be asked to complete a questionnaire to evaluate the intensity of eight common symptoms of HFS/HFSR: pruritus, dryness, erythema, burning sensation, oedema, desquamation, blistering, and pain on an 11-point Numerical Rating Scale (NRS)

Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients.

The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items).

The patients will be asked to evaluate their satisfaction with PBM on a 5-point Likert scale

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effects of Light Therapy to Treat Cancer-related Side Effects	NCT04418856	Breast Cancer Circadian Rhyth... Fatigue Sleep Disturban... Cognitive Impai... Inflammatory Re... Depression	Light Glasses (... Light Glasses (...	18 Years -	Reykjavik University
Lighting Intervention for Cancer-related Fatigue	NCT04827446	Breast Cancer Prostate Cancer Hematologic Mal... Survivorship Fatigue	Wearable Sensor Blue-blocking g... Clear glasses Full SYNC app "Dummy" SYNC ap...	18 Years -	University of Michigan Rogel Cancer Center
Lighting Intervention for Cancer-related Fatigue	NCT04827446	Breast Cancer Prostate Cancer Hematologic Mal... Survivorship Fatigue	Wearable Sensor Blue-blocking g... Clear glasses Full SYNC app "Dummy" SYNC ap...	18 Years -	University of Michigan Rogel Cancer Center
Effect on Fatigue of Light (Lux) Therapy in Patients With Cancer	NCT02879864	Cancer	light therapy Usual care	18 Years -	Fondation Hôpital Saint-Joseph
Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction	NCT04979078	Hand-foot Syndr... Hand-foot Skin ...	Photobiomodulat...	18 Years -	Jessa Hospital
Lighting Intervention for Cancer-related Fatigue	NCT04827446	Breast Cancer Prostate Cancer Hematologic Mal... Survivorship Fatigue	Wearable Sensor Blue-blocking g... Clear glasses Full SYNC app "Dummy" SYNC ap...	18 Years -	University of Michigan Rogel Cancer Center

Spots Global Cancer Trial Database for light therapy