Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04116827
Other study ID # SMC 2018-07-014-011
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 10, 2018
Est. completion date December 31, 2020

Study information

Verified date October 2019
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to observe the sleep and activity patterns of pre-menopausal breast cancer patients taking tamoxifen using a wrist-worn internet of things device and questionnaires.


Description:

Breast cancer is the most common malignant tumors occurring in women worldwide. Treatments include surgery, radiation therapy, chemotherapy, hormone therapy, and target therapy. As multidisciplinary treatment improves breast cancer survival, there is a growing interest in the quality of life of breast cancer survivors. Common symptoms that patients with breast cancer continue to complain of during or after their treatment include fatigue, pain, depression, sleep disorders, weight gain and hot flashes.

There are only a few studies investigating sleep problems in breast cancer patients, which mostly relied on surveys. A commonly used survey evaluation method is the Pittsburg Sleep Quality Index (PSQI). Using PSQI, one study reported that 66% of the Chinese breast cancer survivors had sleep disorders and 49% had significantly reduced sleep efficiency and time in bed. The group with sleep disorder had lower quality of life, more depression and higher overall stress than the group without sleep disorder. Another survey of breast cancer patients over 69 years old found that pain, fatigue and depression were related to sleep, and that fatigue was the strongest predictor of sleep disorders.

A recent study found that postmenopausal breast cancer patients, starting hormone therapy with aromatase inhibitor, total sleep time and sleep efficiency declined without statistical significance. However, 58% of Korean breast cancer patients are pre-menopausal patients aged 49 or younger, and thus, most patients take tamoxifen and goserelin instead of aromatase inhibitors after surgery. In this reason, results of aromatase inhibitor can not be applied in this population. As previous studies on the effects of tamoxifen on sleep were conducted retrospectively, objective comparisons of before and after applying tamoxifen are difficult and the long-term effects of tamoxifen are difficult to understand.

The aim of this study is to observe the sleep and activity patterns of pre-menopausal breast cancer patients taking tamoxifen using a wrist-worn internet of things device and questionnaires.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- diagnosed of unilateral breast cancer (stage 0 ~III)

- underwent proper cancer treatment including surgery, chemotherapy, radiation therapy

- age : 18 ~ 45

- scheduled for applying tamoxifen and goserelin

Exclusion Criteria:

- need CPAP device during sleep due to sleep apnea

- under medication for restless leg syndrome

- previous history of tamoxifen

- irregular bedtime due to shift work

- diagnosed of recurrent or metastatic cancer

- have difficulty understanding and conducting surveys and verbal instructions due to severe cognitive, communication and perception problems

- refuse to participate

- has musculoskeletal system and neurological damage and lesions

Study Design


Intervention

Drug:
Tamoxifen Oral Tablet
Patients who are scheduled for application of tamoxifen and goserelin

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

Azim HA Jr, Davidson NE, Ruddy KJ. Challenges in Treating Premenopausal Women with Endocrine-Sensitive Breast Cancer. Am Soc Clin Oncol Educ Book. 2016;35:23-32. doi: 10.14694/EDBK_159069. — View Citation

Bhave MA, Speth KA, Kidwell KM, Lyden A, Alsamarraie C, Murphy SL, Henry NL. Effect of Aromatase Inhibitor Therapy on Sleep and Activity Patterns in Early-stage Breast Cancer. Clin Breast Cancer. 2018 Apr;18(2):168-174.e2. doi: 10.1016/j.clbc.2017.12.012. — View Citation

Budhrani PH, Lengacher CA, Kip K, Tofthagen C, Jim H. An integrative review of subjective and objective measures of sleep disturbances in breast cancer survivors. Clin J Oncol Nurs. 2015 Apr;19(2):185-91. doi: 10.1188/15.CJON.185-191. Review. — View Citation

Chen D, Yin Z, Fang B. Measurements and status of sleep quality in patients with cancers. Support Care Cancer. 2018 Feb;26(2):405-414. doi: 10.1007/s00520-017-3927-x. Epub 2017 Oct 23. Review. — View Citation

Gonzalez BD, Lu Q. Sleep disturbance among Chinese breast cancer survivors living in the USA. Support Care Cancer. 2018 Jun;26(6):1695-1698. doi: 10.1007/s00520-018-4128-y. Epub 2018 Feb 26. — View Citation

Yfantis A, Intas G, Tolia M, Nikolaou M, Tsoukalas N, Lymperi M, Kyrgias G, Zografos G, Kontos M. Health-related quality of life of young women with breast cancer. Review of the literature. J BUON. 2018 Jan-Feb;23(1):1-6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary total sleep time mean total sleep time per day, recorded by wrist-worn IoT device study enroll~12 months
Primary walking steps and walking time mean walking steps and walking time per day, recorded by wrist-worn IoT device study enroll~12 months
Secondary Pittsburg Sleep Quality Index (PSQI) questionnaire developed to evaluate quality of sleep and sleep disorder study enroll~12 months
Secondary Insomnia Severity Index (ISI) questionnaire developed to evaluate insomnia study enroll~12 months
Secondary Distress thermometer well-known screening tool for psycho-social distress of cancer patients study enroll~12 months
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2