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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer
• Intervention / Treatment: Device: light therapy; Device: Usual care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lionel STAUDACHER, MD; Phone Number: +33 1 44 12 70 33; Email: lstaudacher@hpsj.fr
• Study Contact Backup: Name: Helene BEAUSSIER, PhD, PharmD; Phone Number: +33 1 44 12 70 38; Email: hbeaussier@hpsj.fr

Study Locations

• France
  • Ile-de-France
    • Paris, Ile-de-France, France, 75014
      • Groupe hospitalier Paris saint Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Cancer histologically or cytologically confirmed (regardless of type)
• Patient eligible for first-line chemotherapy
• Life expectancy> 3 months
• WHO PS ≤ 2
• Age ≥ 18 years
• Informed consent signed and dated
• Affiliation to a social security scheme

Exclusion Criteria:

• Macular degeneration
• Diabetic retinopathy
• Glaucoma
• untreated cataract
• Patient treated with vitamin D
• Psychiatric disorders (bipolar disorder, paranoia, schizophrenia)
• For patients with other comorbidities may indicate against-the practice of therapy: application specialist opinion (ophthalmologist or psychiatrist)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Light therapy; 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).	Device: light therapy; 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).
Active Comparator: usual care; 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	Device: Usual care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of change of Tiredness: PIPER Score	Tiredness: PIPER Score (main variable) (22 items targeted in 4 dimensions: behavioral tiredness / intensity, emotional, sensory and cognitive / mood)	Day 1, week 12, week 24 and week 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of change of Quality of life (EORTC-QLQ-C30 SCORE)	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).	Day 1, week 12, week 24 and week 28
Assessment of change of Health General condition WHO SCORE	General condition: WHO	Day 1, week 12, week 24 and week 28
Assessment of change of Pain SCORE	Pain: BPI-Short Form (BPI-SF) and analgesic consumption	Day 1, week 12, week 24 and week 28
Assessment of change of Depression Scale	Depression / Anxiety: scale of depression and anxiety (HADS)	Day 1, week 12, week 24 and week 28
Assessment of change of slumber	Sleep: Pittsburgh questionnaire (PSQI)	Day 1, week 12, week 24 and week 28

Collaborators and Investigators

• Sponsor: Fondation Hôpital Saint-Joseph

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2019
• Primary Completion (Actual): September 20, 2023
• Study Completion (Estimated): April 20, 2024

Study Registration Dates

• First Submitted: August 23, 2016
• First Submitted That Met QC Criteria: August 23, 2016
• First Posted (Estimated): August 26, 2016

Study Record Updates

• Last Update Posted (Actual): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: fatigue; tiredness; luxo therapy; therapy by light
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: EFFLUX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No