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Effect of White Light on Fatigue Levels in Patients With Gynecological Cancer

Sponsor
Eskisehir Osmangazi University (Other)
Overall Status
Completed
CT.gov ID
NCT05009693
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
13.7
Actual Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: White Light Application
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effect of White Light on Fatigue Levels in Patients With Gynecological Cancer: A Double Blind Randomized Trial
Actual Study Start Date :
May 1, 2019
Actual Primary Completion Date :
Jun 20, 2020
Actual Study Completion Date :
Jun 20, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: white light intervention group

Between the second and the eighth days of the application phase, the patients in the intervention group were administered a standard white light at 10,000 Lux intensity by an independent nurse (RA1) in their home environment using a Litebook Elite light source (The Litebook Company Ltd., Medicine Hat, AB). The distance between the light source and the patient's face was set at 50 cm, and the intensity of the light for each patient was checked using a Lux Meter. The intervention was applied between 07:00 and 10:00 in the morning for 30 minutes without interruption, and it was continued for seven successive days. The light application procedure was followed based on the previous studies on oncology patients. The second and third evaluations of the fatigue status of patients were completed on the 9th and 21st days.

Other: White Light Application
White Light Therapy
No Intervention: Control group

Outcome Measures

Primary Outcome Measures

  1. White light changes general fatigue scores [general fatigue levels of patients on 0., 9. and 21. days]

    White light changes general fatigue levels in patients with gynecological cancer

Secondary Outcome Measures

  1. White light changes activity fatigue scores [activity fatigue levels of patients on 0., 9. and 21. days]

    White light changes activity fatigue levels in patients with gynecological cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eskisehir Osmangazi University Faculty of Medicine Eskisehir Turkey 26450

Sponsors and Collaborators

  • Eskisehir Osmangazi University

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Burcu Tuncer Yilmaz, Phd Research Assistant, Eskisehir Osmangazi University
ClinicalTrials.gov Identifier:
NCT05009693
Other Study ID Numbers:
  • WHITELTESOGU
First Posted:
Aug 17, 2021
Last Update Posted:
Aug 17, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Burcu Tuncer Yilmaz, Phd Research Assistant, Eskisehir Osmangazi University
Cancer-related fatigue
White light therapy
Chemotherapy
Clinical trial
Additional relevant MeSH terms:
Fatigue

Study Results

No Results Posted as of Aug 17, 2021