Clinical trial NCT05009693: Effect of White Light on Fatigue Levels in Patients With Gynecological Cancer
Official title: The Effect of White Light on Fatigue Levels in Patients With Gynecological Cancer: A Double Blind Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer-related Fatigue
Light; Therapy, Complications
Keywords: Cancer-related fatigue
White light therapy
Chemotherapy
Clinical trial
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: White light therapy is one of the non-pharmacological methods in the management of fatigue. Cancer-related fatigue (CRF) is a persistent, subjective sense of physical, emotional, and/or cognitive tiredness or burnout. It is associated with cancer or cancer treatment from the first diagnosis until the end of life that is not proportional to recent physical activity.

It was founded that 10,000 Lux bright white light administered in the morning hours reduced fatigue by 17% in patients with cancer and that the mean fatigue scores of patients decreased from 30.37 to 9.48 compared to before the light administration. According to NCCN (2020), white light of 10,000 Lux can be applied for 30-90 minutes in the morning hours to regulate sleep and manage fatigue in the post treatment period as well as in cancer patients receiving active treatment. However, studies on this subject consist of small sample groups, and more studies are needed to identify the risks and benefits of the application and to determine the optimal application time and duration. The present study was aimed to evaluate the effect of white light on the fatigue levels of patients with gynecological cancer who were treated with chemotherapy. The patients with high levels of fatigue in every dimension were selected so as to have a homogeneous group. The research hypotheses were determined as follows:

H0: White light has no effect on fatigue levels in patients with gynecological cancer.

H1: White light reduces fatigue levels in patients with gynecological cancer.


Eligibility criteria: Inclusion Criteria:

* had a normal state of consciousness,
* had no communication disorders, did not work in the night shift,
* had a general fatigue level score of ≥1 according to the Brief Fatigue Inventory

Exclusion Criteria:

* had natural/artificial lenses,
* used medication that causes photosensitivity (tetracycline, doxycycline, nalidixic acid, voriconazole, amiodarone, hydrochlorothiazide, naproxen, piroxicam, chlorpromazine)
* had a change in their treatment plan in the last 6 weeks were not included in the study

Primary outcomes:
measure: White light changes general fatigue scores
timeFrame: general fatigue levels of patients on 0., 9. and 21. days
Secondary outcomes:
measure: White light changes activity fatigue scores
timeFrame: activity fatigue levels of patients on 0., 9. and 21. days
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University Faculty of Medicine
Study officials:
References:
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