Impact of Adjuvant Treatment With Aromatase Inhibitor on Sleep Disturbances in Postmenopausal Women With Endocrine Responsive Early Breast Cancer

Insomnia is common in Breast cancer patients during adjuvant therapy with aromatase inhibitor.

However it is difficult to establish whether it is due to the knowledge of the disease or the treatment administred.

The investigators designed a cohort study in which questionnaires for the assessment of sleep quality (Pittsburgh Sleep Quality Index and Insomnia Severity Index), anxiety (State and Trait Anxiety Inventory), depression (Beck Depression Inventory), for the quality of life in general (Functional Assessment of Cancer Therapy) and for the evaluation of RLS (Restless Legs Syndrome Rating Scale) will be prospectively administered to patients with early breast cancer at baseline and during adjuvant treatment with aromatase inhibitors.

As secondary aims the investigators will also evaluate dietary and lifes' factors, born turn over and BMI.

Study Overview

• Status: Unknown
• Conditions: Endocrine Responsive Early Breast Cancer

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy, 25123
    • Recruiting
    • Azienda Spedali Civili Brescia DH Oncologia
    • Contact: Filippo FR Rodella, Study Coordinator; Phone Number: 00390303996536; Email: oncotrialbrescia@gmail.com
    • Principal Investigator: Rebecca RP Pedersini
    • Sub-Investigator: Lucia LV Vassalli
    • Sub-Investigator: Edda ES Simoncini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal Women with early stage endocrine responsive breast cancer

Description

Inclusion Criteria:

• Women with a histological diagnosis of invasive operated breast cancer (any pT, any pN)
• Women with more than 60 years
• Women less than 60 years with amenorrhea for at least 12 months and FSH and estradiol values in the range of menopause
• Signature of written informed consent.

Exclusion Criteria:

• Locally advanced or metastatic disease (M1)
• A history of breast cancer or other cancers diagnosed in the last 10 years, to exception of basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
• History of severe osteoporosis before the diagnosis of breast cancer
• Bisphosphonate therapy before the diagnosis of breast cancer
• Other serious medical conditions that could limit the ability of the patient to participate in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants who suffer from insomnia	We use some validated questionnaires to measure this item	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants who suffer from anxiety and depression	We use some validated questionnaires to measure this item	24 months
The number of participants who suffer from Restless	We use some validated questionnaires to measure this item	24 months
Correlating the onset of restless with anxiety, depression and insomnia	We analyse correlation into the database	24 months
Describe changes in lean body mass, fat mass, bone mineral density during treatment	We analyse this items after DEXA	24 months
The number of participants with abnormal level of vitamin d	We asses participants with levels of vitamin out of range	24 months
Correlate the changes in body composition with circulating levels of vitamin D	We use statistic software to asses changes	24 months
Number of fracture and their correlation with the density bone mineral and other parameters of body composition	We use statistic software to asses correlation	24 months

Collaborators and Investigators

• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Collaborators: Ospedale San Raffaele
• Investigators: Principal Investigator: Rebecca RP Rebecca, Pedersini, Azienda Spedali Civili Brescia

Publications and helpful links

General Publications

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• 21. Chlebowski RT, Weiner JM, Reynolds R, Luce J, Bulcavage L, Bateman JR (1986) Breast Cancer Res Treat 7(1):23-30) 22 Demark-Wahnefried W, Winer EP, Rimer BK (1993) J Clin Oncol 11(7):1418-1429). 23 Demark-Wahnefried W, Hars V, Conaway MR, et al. Am J Clin Nutr. 1997;65(5):1495-501 24 Demark-Wahnefried W, Rimer BK, Winer EP (1997) J Am Dietetic Assoc, 97(5):519-526, 529 (quiz 527-518) 25.Fisher B, Dignam J, Bryant J, et al. J Natl Cancer Inst 88(21):1529-1542, 1996 26. Day R, Ganz PA, Costantino JP, et al. J Clin Oncol 17(9):2659-2669, 1999 27. Powles T, Eeles R, Ashley S, et al. Lancet 352(9122):98-101 , 1998 28 Wahnefried WD, Campbell KL, Hayes SC. Cancer 15: 2277- 2287, 2012 29. Van Londen GJ, Perera S, Vujevich K, et al. Breast Cancer Res Treat; 125(2): 441-446, 2011 30 Berrino F, Pasanisi P, Bellati C I nt J Cancer 113: 499-502, 2005 31.Goodwin PJ, Ennis M, Pritchard KI, et al. J Clin Oncol. 2012 Jan 10;30(2):164-71. 32. Duggan C, Irwin ML, Xiao L, et al. J Clin Oncol. 2011 Jan 1;29(1):32-9. 33 Rabaglio M, Sun Z, Prince KN, et al. Ann Oncol 20: 1489-1498, 2009 34 Hillner BE, Ingle JN, Chlebowski RT, et al. J Clin Oncol. 2003 1;21(21):4042-57. 35.Kanis J, Borgstrom F, De Laet C, et al. Int 16: 581-589; 2005 36. Berruti A, Tucci M, Mosca A, Vana F et al. J Clin Oncol., 10;25(11):1455-6, 2007 37 Bischoff-Ferrari HA, Giovannucci E, Willet WC, et al. Am J clin Nutr 2006; 84: 18 38 Rastelli AL, Taylor ME, Gao F, et al. Breast Cancer Res Treat, 2011 107-16, 2011 39. Singh S, Cuzick J, Mesher D, et al. Breast cancer Res Treat 2012: 132: 625-629 40. Helzlsouer KJ, Gallicchio L, MacDonald R, et al. Breast Cancer Res Treat 2012; 131 (1): 277-85
• 41 Park S, Ham JO, Lee BK. Clin Nutr, 2013 S0261-5614(13)00256-2. 42 Buttigliero C, Monagheddu C, Petroni P, et al. Oncologist.16(9):1215-27, 2011 43 Otte J, Rand K, carpenter J et al. Journal of pain and symptom management: 1-8; 2012 44 Buysse DJ, Reynolds CF, Monk TH, et al. Psychiatry res 28: 193-213, 1989 45 Zigmond AS, Snaith RP. Acta psychiatr scand 1983; 67: 361-370 46 Brady MJ, Cella DF, Mo F. J Clin Oncol 15; 974-986, 1997 47 Abetz L, Arbuckle R, Allen RP, et al. Sleep Med 2006;7:340-349. 48.Coombes RC, Kilburn LS, Snowdon CF et al. Lancet 369: 559-570, 2007 49 Linee guida Rete oncologica lombarda 50. Hillner BE, Ingle JN, Chlebowski RT, et alClin Oncol 21:4042-4057, 2003 51. Gralow JR, Biermann JS, Farooki A, et al. J Natl Compr Canc Netw 7:S1-S32, 2009; S33-S35 (suppl 3) 52. Hadji P, Aapro MS, Body JJ, et al. Ann Oncol 22:2546-2555, 2011 53. Rizzoli R, Body JJ, De Censi A, et al. Osteoporos Int [epub ahead of print on January 20, 2012] 54. Body JJ, Bergmann P, Boonen S, et al. Osteoporos Int 18:1439-1450, 2007 55.David M, Julie D, , Richard E, et al. A consensus position statement from a UK Expert Group Cancer Treatment Reviews (2008) 34, S3- S18 56.Savard MH, Savard J, Simard S et al. Psycho-Oncology 14:429-441, 2005 57. Spielberger C. Consulting Psychologists Press; 1983. 58. Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J. Arch Gen Psychiatry. 1961 Jun;4:561-71. 59. Lichstein KL, Stone KC, Donaldson J et al. Sleep 29(2): 232-239, 2006. 60.Sack RL, Pires ML, Brandes RW et al.Vol. 24 Supplement Abstract #719.R, pg.A405, Sleep 2001. 61. King MA, Jaffre MO, Morrish E et al. Sleep Medicine 6(4): 1-7, 2005.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: May 20, 2014
• First Submitted That Met QC Criteria: June 16, 2014
• First Posted (Estimate): June 18, 2014

Study Record Updates

• Last Update Posted (Estimate): June 18, 2014
• Last Update Submitted That Met QC Criteria: June 16, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Body composition; Insomnia; Aromatase inhibitor; Restless leg syndrome
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Comfort