AzTrials
AzTrials

Endocrine Responsive Early Breast CancerNCT02166281

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

An observational study of Endocrine Responsive Early Breast Cancer, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endocrine Responsive Early Breast Cancer
How many people
200 participants
Where
1 siteItaly
Study dates
May 2014to May 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Postmenopausal Women with early stage endocrine responsive breast cancer

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Rebecca RP Pedersini, Principal Investigator contact

03033996536

oncotrialbrescia@gmail.com

Italy1 site, 1 recruiting

  • Azienda Spedali Civili Brescia DH Oncologia

    Brescia, Brescia, 25123

    Filippo FR Rodella, Study Coordinator, 00390303996536, oncotrialbrescia@gmail.com

    Rebecca RP Pedersini

    Recruiting

Other trials in Italy

About this study

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.

Read more

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.

Keywords
Insomnia, Anxiety, Depression, Restless leg syndrome, Aromatase inhibitor, Body composition
Medical subject headings
Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Depression, Restless Legs Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of participants who suffer from insomnia

    We use some validated questionnaires to measure this item

    Measured: 24 months

Secondary outcomes (7)

  1. The number of participants who suffer from anxiety and depression

    We use some validated questionnaires to measure this item

    Measured: 24 months

  2. The number of participants who suffer from Restless

    We use some validated questionnaires to measure this item

    Measured: 24 months

  3. Correlating the onset of restless with anxiety, depression and insomnia

    We analyse correlation into the database

    Measured: 24 months

  4. Describe changes in lean body mass, fat mass, bone mineral density during treatment

    We analyse this items after DEXA

    Measured: 24 months

  5. The number of participants with abnormal level of vitamin d

    We asses participants with levels of vitamin out of range

    Measured: 24 months

  6. Correlate the changes in body composition with circulating levels of vitamin D

    We use statistic software to asses changes

    Measured: 24 months

  7. Number of fracture and their correlation with the density bone mineral and other parameters of body composition

    We use statistic software to asses correlation

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionMay 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02166281
Sponsor's protocol ID
Comfort
Status last verified
Jun 2014
First submitted
20 May 2014
Last updated
18 Jun 2014
Results posted
No
Data monitoring committee
No

Publications

  • 1.Early Breast Cancer Trialists' Collaborative Group.Lancet 2005;365:1687-1717. 2.Slamon D, Eiermann W, Robert N, et al. NEJM 2011;365:1273-1283. 3.The Arimidex, Tamoxifen, Alone or in Combination (ATAC) Trialists' Group, et al. Lancet Oncol, 2008;9:45-53. 4. The BIG 1-98 Collaborative Group. New Engl J Med 2009;361:766-776. 5. Dowsett M, Cuzick J, Ingle J, et al. J Clin Oncol 2010;28:509-518. 6. Forbes JF, Cuzick J, Buzdar A et al. Lancet Oncol 9: 45-53, 2008 7. Monnier A. Eur J Cancer Supplements 2008;6 (7):113. 8.Bower JE. J Clin Oncol. 2008, 10;26(5):768-77. 9. Desai K, Mao JJ, Su I, Demichele A, Li Q, Xie SX, Gehrman PR. Support Care Cancer. 21(1):43-51, 2013 10. Lockefeer JPM, De Vries J. Psico-oncology 2013;22(5):1127-33 11. Julienne E. Bower, Patricia A. Ganz, Michael R. Irwin, et al.J Clin Oncol. 2011,29;26(10):3517-3522. 12. Floortje Mols A, Vingerhoets B, Jan Willem Coebergh A. European Journal of Cancer 41: 2613-2619, 2005 13.Meunier A, Bachelot T, leynet E, et al. San Antonio Breast Cancer Symposium, 2008 14 Saini A, Berruti A, Ferini-Strambi L, et al. Pain Symptom Manage. 2013;46(1):56-64. 15. Luca Ostacoli, Andrea Saini, Luigi Ferini-Strambi et al. Qual Life Res, 2010 16 Tredan O, Bajard A, Meunier A, et al.Clin Nutr 29(2):187-191, 2010; 17. Harvie MN, Campbell IT, Baildam A, et al. Breast Cancer Res Treat 83(3):201-210, 2007 18. Goodwin PJ, Ennis M, Pritchard KI, et al. J Clin Oncol 17(1):120-129, 1999 19.Hoskin PJ, Ashley S, Yarnold JR. Breast Cancer Res Treat 22(2):129-132, 1992 20.Camoriano JK, Loprinzi CL, Ingle JN, Therneau TM, Krook JE,Veeder MH (1990) J Clin Oncol 8(8):1327-1334,

  • 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Endocrine Responsive Early Breast Cancer, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rebecca RP Pedersini, Principal Investigator (03033996536, oncotrialbrescia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of participants who suffer from insomnia (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02166281, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2014.

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