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

Cancer-related Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05009693
• Other study ID #: WHITELTESOGU
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: June 20, 2020

Study information

• Verified date: August 2021
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 20, 2020
• Est. primary completion date: June 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer-related Fatigue
• Fatigue
• Light; Therapy, Complications

Intervention

Other:
• White Light Application
White Light Therapy

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University Faculty of Medicine	Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (16)

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Redd WH, Valdimarsdottir H, Wu LM, Winkel G, Byrne EE, Beltre MA, Liebman ES, Erazo T, Hayes JA, Isola L, Scigliano E, Meschian Y, Lutgendorf S, Ancoli-Israel S. Systematic light exposure in the treatment of cancer-related fatigue: a preliminary study. Psychooncology. 2014 Dec;23(12):1431-4. doi: 10.1002/pon.3553. Epub 2014 May 2. — View Citation

Starreveld DEJ, Daniels LA, Valdimarsdottir HB, Redd WH, de Geus JL, Ancoli-Israel S, Lutgendorf S, Korse CM, Kieffer JM, van Leeuwen FE, Bleiker EMA. Light therapy as a treatment of cancer-related fatigue in (non-)Hodgkin lymphoma survivors (SPARKLE trial): study protocol of a multicenter randomized controlled trial. BMC Cancer. 2018 Sep 10;18(1):880. doi: 10.1186/s12885-018-4746-2. — View Citation

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* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	White light changes general fatigue scores	White light changes general fatigue levels in patients with gynecological cancer	general fatigue levels of patients on 0., 9. and 21. days
Secondary	White light changes activity fatigue scores	White light changes activity fatigue levels in patients with gynecological cancer	activity fatigue levels of patients on 0., 9. and 21. days