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

NCT02879864 | Unknown DMC

• 1 other identifier: EFFLUX
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

fatigue; tiredness; luxo therapy; therapy by light

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Assessment of change of Quality of life (EORTC-QLQ-C30 SCORE)

  Day 1, week 12, week 24 and week 28

• Assessment of change of Health General condition WHO SCORE

  Day 1, week 12, week 24 and week 28

• Assessment of change of Pain SCORE

  Day 1, week 12, week 24 and week 28

• Assessment of change of Depression Scale

  Day 1, week 12, week 24 and week 28

• Assessment of change of slumber

  Day 1, week 12, week 24 and week 28

Study Arms (2)

Light therapy

EXPERIMENTAL

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

usual care

ACTIVE COMPARATOR

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

Interventions

light therapy DEVICE

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

Usual care DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Neoplasms; Fatigue

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: August 26, 2016
• Study Start: March 20, 2019
• Primary Completion: September 20, 2023
• Study Completion: April 20, 2024
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

FR (1)