Evaluation of Eating Habits and Dysgeusia During Chemotherapy Treatment in Patients Affected by Breast Cancer (CHANGE)

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ClinicalTrials.gov Identifier: NCT03210441

Recruitment Status : Unknown

Verified July 2017 by LUCIA VASSALLI, Azienda Ospedaliera Spedali Civili di Brescia.
Recruitment status was: Recruiting

First Posted : July 7, 2017

Last Update Posted : July 7, 2017

Sponsor:

Information provided by (Responsible Party):

LUCIA VASSALLI, Azienda Ospedaliera Spedali Civili di Brescia

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Unknown
Estimated Primary Completion Date :	May 6, 2018
Estimated Study Completion Date :	May 6, 2018

Publications of Results:

Ewertz M, Jensen MB, Gunnarsdóttir KÁ, Højris I, Jakobsen EH, Nielsen D, Stenbygaard LE, Tange UB, Cold S. Effect of obesity on prognosis after early-stage breast cancer. J Clin Oncol. 2011 Jan 1;29(1):25-31. doi: 10.1200/JCO.2010.29.7614. Epub 2010 Nov 29.

Other Publications:

Sinicrope FA, Dannenberg AJ. Obesity and breast cancer prognosis: weight of the evidence. J Clin Oncol. 2011 Jan 1;29(1):4-7. doi: 10.1200/JCO.2010.32.1752. Epub 2010 Nov 29.

Chlebowski RT, Aiello E, McTiernan A. Weight loss in breast cancer patient management. J Clin Oncol. 2002 Feb 15;20(4):1128-43. Review.

Goodwin PJ, Boyd NF. Body size and breast cancer prognosis: a critical review of the evidence. Breast Cancer Res Treat. 1990 Oct;16(3):205-14. Review.

Obermair A, Kurz C, Hanzal E, Bancher-Todesca D, Thoma M, Bodisch A, Kubista E, Kyral E, Kaider A, Sevelda P, et al. The influence of obesity on the disease-free survival in primary breast cancer. Anticancer Res. 1995 Sep-Oct;15(5B):2265-9.

Litton JK, Gonzalez-Angulo AM, Warneke CL, Buzdar AU, Kau SW, Bondy M, Mahabir S, Hortobagyi GN, Brewster AM. Relationship between obesity and pathologic response to neoadjuvant chemotherapy among women with operable breast cancer. J Clin Oncol. 2008 Sep 1;26(25):4072-7. doi: 10.1200/JCO.2007.14.4527.

Rosner GL, Hargis JB, Hollis DR, Budman DR, Weiss RB, Henderson IC, Schilsky RL. Relationship between toxicity and obesity in women receiving adjuvant chemotherapy for breast cancer: results from cancer and leukemia group B study 8541. J Clin Oncol. 1996 Nov;14(11):3000-8.

Trédan O, Bajard A, Meunier A, Roux P, Fiorletta I, Gargi T, Bachelot T, Guastalla JP, Lallemand Y, Faure C, Pérol D, Bachmann P. Body weight change in women receiving adjuvant chemotherapy for breast cancer: a French prospective study. Clin Nutr. 2010 Apr;29(2):187-91. doi: 10.1016/j.clnu.2009.08.003. Epub 2009 Aug 26.

Saquib N, Flatt SW, Natarajan L, Thomson CA, Bardwell WA, Caan B, Rock CL, Pierce JP. Weight gain and recovery of pre-cancer weight after breast cancer treatments: evidence from the women's healthy eating and living (WHEL) study. Breast Cancer Res Treat. 2007 Oct;105(2):177-86. Epub 2006 Nov 23.

Harvie MN, Campbell IT, Baildam A, Howell A. Energy balance in early breast cancer patients receiving adjuvant chemotherapy. Breast Cancer Res Treat. 2004 Feb;83(3):201-10.

Goodwin PJ, Ennis M, Pritchard KI, McCready D, Koo J, Sidlofsky S, Trudeau M, Hood N, Redwood S. Adjuvant treatment and onset of menopause predict weight gain after breast cancer diagnosis. J Clin Oncol. 1999 Jan;17(1):120-9.

Demark-Wahnefried W, Rimer BK, Winer EP. Weight gain in women diagnosed with breast cancer. J Am Diet Assoc. 1997 May;97(5):519-26, 529; quiz 527-8. Review.

Demark-Wahnefried W, Winer EP, Rimer BK. Why women gain weight with adjuvant chemotherapy for breast cancer. J Clin Oncol. 1993 Jul;11(7):1418-29. Review.

Demark-Wahnefried W, Hars V, Conaway MR, Havlin K, Rimer BK, McElveen G, Winer EP. Reduced rates of metabolism and decreased physical activity in breast cancer patients receiving adjuvant chemotherapy. Am J Clin Nutr. 1997 May;65(5):1495-501.

Camoriano JK, Loprinzi CL, Ingle JN, Therneau TM, Krook JE, Veeder MH. Weight change in women treated with adjuvant therapy or observed following mastectomy for node-positive breast cancer. J Clin Oncol. 1990 Aug;8(8):1327-34.

Chlebowski RT, Weiner JM, Reynolds R, Luce J, Bulcavage L, Bateman JR. Long-term survival following relapse after 5-FU but not CMF adjuvant breast cancer therapy. Breast Cancer Res Treat. 1986;7(1):23-30.

Hoskin PJ, Ashley S, Yarnold JR. Weight gain after primary surgery for breast cancer--effect of tamoxifen. Breast Cancer Res Treat. 1992;22(2):129-32.

Fisher B, Dignam J, Bryant J, DeCillis A, Wickerham DL, Wolmark N, Costantino J, Redmond C, Fisher ER, Bowman DM, Deschênes L, Dimitrov NV, Margolese RG, Robidoux A, Shibata H, Terz J, Paterson AH, Feldman MI, Farrar W, Evans J, Lickley HL. Five versus more than five years of tamoxifen therapy for breast cancer patients with negative lymph nodes and estrogen receptor-positive tumors. J Natl Cancer Inst. 1996 Nov 6;88(21):1529-42.

Day R, Ganz PA, Costantino JP, Cronin WM, Wickerham DL, Fisher B. Health-related quality of life and tamoxifen in breast cancer prevention: a report from the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Clin Oncol. 1999 Sep;17(9):2659-69.

Powles T, Eeles R, Ashley S, Easton D, Chang J, Dowsett M, Tidy A, Viggers J, Davey J. Interim analysis of the incidence of breast cancer in the Royal Marsden Hospital tamoxifen randomised chemoprevention trial. Lancet. 1998 Jul 11;352(9122):98-101.

Baum M, Buzdar A, Cuzick J, Forbes J, Houghton J, Howell A, Sahmoud T; ATAC (Arimidex, Tamoxifen Alone or in Combination) Trialists' Group. Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early-stage breast cancer: results of the ATAC (Arimidex, Tamoxifen Alone or in Combination) trial efficacy and safety update analyses. Cancer. 2003 Nov 1;98(9):1802-10.

Francini G, Petrioli R, Montagnani A, Cadirni A, Campagna S, Francini E, Gonnelli S. Exemestane after tamoxifen as adjuvant hormonal therapy in postmenopausal women with breast cancer: effects on body composition and lipids. Br J Cancer. 2006 Jul 17;95(2):153-8.

Sestak I, Harvie M, Howell A, Forbes JF, Dowsett M, Cuzick J. Weight change associated with anastrozole and tamoxifen treatment in postmenopausal women with or at high risk of developing breast cancer. Breast Cancer Res Treat. 2012 Jul;134(2):727-34. doi: 10.1007/s10549-012-2085-6. Epub 2012 May 16.

Blackburn GL, Wang KA. Dietary fat reduction and breast cancer outcome: results from the Women's Intervention Nutrition Study (WINS). Am J Clin Nutr. 2007 Sep;86(3):s878-81. doi: 10.1093/ajcn/86.3.878S. Review.

Hovan AJ, Williams PM, Stevenson-Moore P, Wahlin YB, Ohrn KE, Elting LS, Spijkervet FK, Brennan MT; Dysgeusia Section, Oral Care Study Group, Multinational Association of Supportive Care in Cancer (MASCC)/International Society of Oral Oncology (ISOO). A systematic review of dysgeusia induced by cancer therapies. Support Care Cancer. 2010 Aug;18(8):1081-7. doi: 10.1007/s00520-010-0902-1. Epub 2010 May 22. Review.

Ravasco P. Aspects of taste and compliance in patients with cancer. Eur J Oncol Nurs. 2005;9 Suppl 2:S84-91. Review.

Bernhardson BM, Tishelman C, Rutqvist LE. Self-reported taste and smell changes during cancer chemotherapy. Support Care Cancer. 2008 Mar;16(3):275-83. Epub 2007 Aug 21.

Hong JH, Omur-Ozbek P, Stanek BT, Dietrich AM, Duncan SE, Lee YW, Lesser G. Taste and odor abnormalities in cancer patients. J Support Oncol. 2009 Mar-Apr;7(2):58-65. Review.

Gamper EM, Giesinger JM, Oberguggenberger A, Kemmler G, Wintner LM, Gattringer K, Sperner-Unterweger B, Holzner B, Zabernigg A. Taste alterations in breast and gynaecological cancer patients receiving chemotherapy: prevalence, course of severity, and quality of life correlates. Acta Oncol. 2012 Apr;51(4):490-6. doi: 10.3109/0284186X.2011.633554. Epub 2011 Nov 30.

Augusto C, Pietro M, Cinzia M, Sergio C, Sara C, Luca G, Scaioli V. Peripheral neuropathy due to paclitaxel: study of the temporal relationships between the therapeutic schedule and the clinical quantitative score (QST) and comparison with neurophysiological findings. J Neurooncol. 2008 Jan;86(1):89-99. Epub 2007 Jul 5.

Lee JJ, Swain SM. Peripheral neuropathy induced by microtubule-stabilizing agents. J Clin Oncol. 2006 Apr 1;24(10):1633-42. Review.

Heckmann JG, Heckmann SM, Lang CJ, Hummel T. Neurological aspects of taste disorders. Arch Neurol. 2003 May;60(5):667-71. Review.

Cella D, Peterman A, Hudgens S, Webster K, Socinski MA. Measuring the side effects of taxane therapy in oncology: the functional assesment of cancer therapy-taxane (FACT-taxane). Cancer. 2003 Aug 15;98(4):822-31.

Kano T, Kanda K. Development and validation of a chemotherapy-induced taste alteration scale. Oncol Nurs Forum. 2013 Mar;40(2):E79-85. doi: 10.1188/13.ONF.E79-E85.

Strasser F, Demmer R, Böhme C, Schmitz SF, Thuerlimann B, Cerny T, Gillessen S. Prevention of docetaxel- or paclitaxel-associated taste alterations in cancer patients with oral glutamine: a randomized, placebo-controlled, double-blind study. Oncologist. 2008 Mar;13(3):337-46. doi: 10.1634/theoncologist.2007-0217.

Rehwaldt M, Wickham R, Purl S, Tariman J, Blendowski C, Shott S, Lappe M. Self-care strategies to cope with taste changes after chemotherapy. Oncol Nurs Forum. 2009 Mar;36(2):E47-56. doi: 10.1188/09.ONF. E47-E56.

Speck RM, DeMichele A, Farrar JT, Hennessy S, Mao JJ, Stineman MG, Barg FK. Taste alteration in breast cancer patients treated with taxane chemotherapy: experience, effect, and coping strategies. Support Care Cancer. 2013 Feb;21(2):549-55. doi: 10.1007/s00520-012-1551-3. Epub 2012 Aug 5.

Buttigliero C, Monagheddu C, Petroni P, Saini A, Dogliotti L, Ciccone G, Berruti A. Prognostic role of vitamin d status and efficacy of vitamin D supplementation in cancer patients: a systematic review. Oncologist. 2011;16(9):1215-27. doi: 10.1634/theoncologist.2011-0098. Epub 2011 Aug 11. Review.

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