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Completed

NCT Number: NCT05009693

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

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.

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Key information

Conditions

Cancer-related Fatigue Light; Therapy, Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eskisehir Osmangazi University Faculty of Medicine

Eskişehir, 26450, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

White Light Application

Other

White Light Therapy

Primary outcomes

  1. White light changes general fatigue scores

    Time frame: general fatigue levels of patients on 0., 9. and 21. days

    White light changes general fatigue levels in patients with gynecological cancer

Secondary outcomes

  1. White light changes activity fatigue scores

    Time frame: activity fatigue levels of patients on 0., 9. and 21. days

    White light changes activity fatigue levels in patients with gynecological cancer

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

The Effect of White Light on Fatigue Levels in Patients With Gynecological Cancer: A Double Blind Randomized Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 17, 2021
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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