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

NCT05009693 | Completed

• 1 other identifier: WHITELTESOGU
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer-related Fatigue; Light; Therapy, Complications

Keywords

Cancer-related fatigue; White light therapy; Chemotherapy; Clinical trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• White light changes activity fatigue scores

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

Study Arms (2)

white light intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Interventions

White Light Application OTHER

White Light Therapy

white light intervention group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi University Faculty of Medicine

Eskişehir, 26450, Turkey (Türkiye)

Location

Related Publications (17)

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  PMID: 33070045 BACKGROUND

• National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. Cancer related fatigue [Internet]. Version 1.2021. 2020. Available from: https://www.nccn.org/professionals/physician_gls/pdf/fatigue.pdf

  BACKGROUND

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  BACKGROUND

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  PMID: 19884558 BACKGROUND

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  PMID: 30789284 BACKGROUND

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  PMID: 19995675 BACKGROUND

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  PMID: 25993156 BACKGROUND

• Alcantara-Silva TR, de Freitas-Junior R, Freitas NMA, de Paula Junior W, da Silva DJ, Machado GDP, Ribeiro MKA, Carneiro JP, Soares LR. Music Therapy Reduces Radiotherapy-Induced Fatigue in Patients With Breast or Gynecological Cancer: A Randomized Trial. Integr Cancer Ther. 2018 Sep;17(3):628-635. doi: 10.1177/1534735418757349. Epub 2018 Apr 10.

  PMID: 29633652 BACKGROUND

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  PMID: 23737693 BACKGROUND

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  PMID: 30200906 BACKGROUND

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  PMID: 29127575 BACKGROUND

• Mendoza TR, Wang XS, Cleeland CS, Morrissey M, Johnson BA, Wendt JK, Huber SL. The rapid assessment of fatigue severity in cancer patients: use of the Brief Fatigue Inventory. Cancer. 1999 Mar 1;85(5):1186-96. doi: 10.1002/(sici)1097-0142(19990301)85:53.0.co;2-n.

  PMID: 10091805 BACKGROUND

• 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. No abstract available.

  PMID: 24798589 BACKGROUND

• Steur LMH, Kaspers GJL, Van Someren EJW, Van Eijkelenburg NKA, Van der Sluis IM, Dors N, Van den Bos C, Tissing WJE, Grootenhuis MA, Van Litsenburg RRL. Sleep-wake rhythm disruption is associated with cancer-related fatigue in pediatric acute lymphoblastic leukemia. Sleep. 2020 Jun 15;43(6):zsz320. doi: 10.1093/sleep/zsz320.

  PMID: 31889198 BACKGROUND

• Kronish IM, Cheung YK, Julian J, Parsons F, Lee J, Yoon S, Valdimarsdottir H, Green P, Suls J, Hershman DL, Davidson KW. Clinical Usefulness of Bright White Light Therapy for Depressive Symptoms in Cancer Survivors: Results from a Series of Personalized (N-of-1) Trials. Healthcare (Basel). 2019 Dec 30;8(1):10. doi: 10.3390/healthcare8010010.

  PMID: 31905890 BACKGROUND

• Ozerdogan N, Ozkaraman A, Tuncer Yilmaz B, Oge T, Yalcin OT. The Effect of Bright White Light on Fatigue Levels in Patients with Gynecological Cancer: A Randomized Control Trial. J Palliat Care. 2023 Oct;38(4):416-423. doi: 10.1177/08258597221127795. Epub 2022 Sep 25.

  PMID: 36154518 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd Research Assistant

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 17, 2021
• Study Start: May 1, 2019
• Primary Completion: June 20, 2020
• Study Completion: June 20, 2020
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)