Breast CancerCHANGENCT03210441
Evaluation of Eating Habits and Dysgeusia During Chemotherapy Treatment in Patients Affected by Breast Cancer
An observational study of Breast Cancer and Dysgeusia, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
In post-menopause women affected by breast cancer and treated with chemotherapy, overweight and obesity are considered both a risk factors as well as a negative prognostic factors since they increase the risk of early relapse and death. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Dysgeusia, Eating Behavior
- How many people
- 204 participants
- Where
- 1 siteItaly
- Study dates
- 6 May 2014to 6 May 2018
- 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: Patients affected by invasive breast cancer
Who may be able to join
- Pre- and post-menopause women with histologic diagnosis of invasive breast cancer surgically treated (all pT and all pN)
- Patients must provide written informed consent to be enrolled in the study
Who cannot join
- Locally extended or metastatic (M1) disease;
- Previous surgical or radio therapeutic treatment (up to one year before the selection) in oral or nasal region;
- Other serious medical conditions that can limit patient capability to participate in this study.
Trial locations and contacts
1 site in 1 country.
Lucia Vassalli, MD contact
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123
Lucia Vassalli, MD, lucia.vassalli@libero.it
About this study
Official title: Evaluation of Eating Habits and Dysgeusia During Chemotherapy Treatment: a Prospective Cohort Study on Patients Affected by Breast Cancer
In post-menopause women affected by breast cancer and treated with chemotherapy, overweight and obesity are considered both a risk factors as well as a negative prognostic factors since they increase the risk of early relapse and death. Furthermore, a decrease in weight may also occur during chemotherapy and is associated to a reduced quality of life and survival. Also, the majority of patients under chemotherapy refer dysgeusia, an alteration in taste that can determine food aversion, selection of hypercaloric food or reduced food introduction up to malnutrition. Our aim is to evaluate eating habits changes in patients affected by breast cancer and under chemotherapy treatment and to better understand how this alterations influence the quality of life, anxiety, depression and insomnia of patients as well as overall survival.
Read the detailed description
INTRODUCTION
Overweight and obesity represent a risk factor for hormone dependent cancers such as breast, endometrium, ovarian, uterine and gastrointestinal cancer.
In particular, overweight and obesity are risk factors for breast cancer in post-menopause women since they are associated to higher level of circulating estrogens, insulin, insulin-like growth factor levels, leptin, adiponectin, growth factors (such as hepatocyte growth factor) and inflammatory cytokines (TNFα and Interleukin-6 (IL-6)). Moreover, they reduce sex hormone binding globulin (SHBG) plasma levels. Overweight and obesity are also negative prognostic factors for breast cancer in post-menopause women since they increase the risk of early relapse and death. An increased weight (2.5-6.2 Kg) is commonly reported during chemotherapy treatment in post-menopause women. This is due to increased appetite, hyperphagia and hydric retention associated with reduced metabolism and physic activities. However, the weight gain during therapy is still not recognised as a negative prognostic factor.
Furthermore, a decrease in weight may also occur during chemotherapy. This is mainly due to lower appetite and early satiety, dysgeusia, nausea and vomiting or intolerance to certain foods. Decreasing weight can determine less efficacy and tolerance in therapy, more complications/infections, more and longer hospitalisations and, as a consequence, a reduced quality of life and survival.
Dysgeusia is an alteration in taste that can determine food aversion, selection of hypercaloric food or reduced food introduction up to malnutrition. More than 75% of patients under chemotherapy refer dysgeusia; this is related to drugs (such as folic acid competitors, cyclophosphamide cisplatin and taxanes) and can last for weeks. ln particular, taxanes determine a peripheral nerves degeneration. The results are a metallic taste and an alteration in salted perception. In addition, they determine a dose-dependent chemotherapy-induced peripheral neuropathy (CIPN) with painful paraesthesia, total areflexia and muscular extremities weakness. Dysgeusia is an underestimated problem. Instrumental examinations and laboratory tests can be useful but they cannot replace a detailed medical history and a close physical examination associated with international validate questionnaires.
At the moment, no agreement was found on chemotherapy-induced dysgeusia prevention and therapy. Patients resolve this problems with cold food, candies before meals and sugary drinks and these behaviours lead to increasing in weight.
STUDY DESIGN
This is a prospective cohort study for the evaluation of eating habits changes and dysgeusia in patients with breast cancer during chemotherapy treatment. It will explore also the potential relations with anxiety, depression, insomnia and quality of life. These evaluations will be actuated using internationally validate questionnaires.
METHODS
This study is based on the collection of data with international validate questionnaires:
- Food frequency questionnaire (FFQ) and photography atlas
- Chemotherapy-induced taste alteration scale (CiTAS): evaluation of changes in taste.
- Functional assessment of cancer therapy (FACT_B): evaluation of quality of life for physical health, social and familiar health, emotional health, functional health and health in relation with the pathology.
- Beck depression inventory (BDI) and HADS: evaluation of depression presence and its intensity.
- Pittsburgh sleep quality index (PSQI) and insomnia severity index (ISI): evaluation of sleep quality.
- State and trait anxiety inventory (STAI-Y): evaluation of anxiety presence and its intensity.
STATISTICAL CONSIDERATIONS
Based on the proportion of the women in overweight before chemotherapy is 30% and the proportion of the women in overweight after chemotherapy is 50% (with a 5% α error and an 80% strength), the established number of patients to include in the study is 186. In prevision of a 10% loss of patients in follow-up, 204 patients will be included in the study.
- Conditions
- Breast Cancer, Dysgeusia, Eating Behavior, Quality of Life
- Medical subject headings
- Breast Neoplasms, Dysgeusia, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients affected by breast cancer and potentially treated with taxane chemotherapy | |
| Group 2 | Patients affected by breast cancer and not potentially treated without taxane chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate eating habits changes in patients affected by breast cancer during chemotherapy treatment
Appearence of dysgeusia, asthenia, diarrhoea, decreased or increased appetite, mucositis, nausea, stypsis, vomiting and meteorism will be evaluated throught Food frequency questionaire (FFQ) compared to baseline (nefore chemotherapy)
Measured: From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Secondary outcomes (7)
Evaluation of dysgeusia
Presence of changes in food taste (sweet, salt, bitter) and food smell compared to baseline in patients treated with taxanes throught the evaluation of a food questionnaire
Measured: From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of weight alterations
Evaluation of the correlation between eating habits changes and dysgeusia with changes in weight through weight/height measurement and BMI calculation to evaluate the influence of eating habits changes and changes in weight on outcome in patients (relapse free interval (RFI) and overall survival (OS))
Measured: From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of eating habits changes
Food frequency questionnaire (FFQ), chemotherapy-induced taste alteration scale questionnaire (CiTAS)
Measured: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of the impact of eating habits changes and dysgeusia on quality of life
functional assessment of cancer therapy questionnaire (FACT_B)
Measured: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of the impact of eating habits changes and dysgeusia on depression
beck depression inventory (BDI) and HADS test
Measured: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of the impact of eating habits changes and dysgeusia on insomnia
pittsburgh sleep quality index (PSQI) and insomnia severity index (ISI)
Measured: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of the impact of eating habits changes and dysgeusia on anxiety, depression
state and trait anxiety inventory (STAI-Y) will be administered to patients
Measured: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start6 May 2014
- Primary completion6 May 2018 (estimated)
- Study completion6 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LUCIA VASSALLI, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Lucia Vassalli, MD, Principal investigator, Asst Degli Spedali Civili Di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210441
- Sponsor's protocol ID
- NP2488
- Acronym
- CHANGE
- Status last verified
- Jul 2017
- First submitted
- 15 Jun 2017
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. No abstract available.
PubMed 21115867Chlebowski RT, Aiello E, McTiernan A. Weight loss in breast cancer patient management. J Clin Oncol. 2002 Feb 15;20(4):1128-43. doi: 10.1200/JCO.2002.20.4.1128.
PubMed 11844838Goodwin 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. doi: 10.1007/BF01806329.
PubMed 2085672Obermair 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.
PubMed 8572635Litton 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.
PubMed 18757321Rosner 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. doi: 10.1200/JCO.1996.14.11.3000.
PubMed 8918498Tredan O, Bajard A, Meunier A, Roux P, Fiorletta I, Gargi T, Bachelot T, Guastalla JP, Lallemand Y, Faure C, Perol 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.
PubMed 19713014Saquib 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. doi: 10.1007/s10549-006-9442-2. Epub 2006 Nov 23.
PubMed 17123151Harvie 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. doi: 10.1023/B:BREA.0000014037.48744.fa.
PubMed 14758090Goodwin 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. doi: 10.1200/JCO.1999.17.1.120.
PubMed 10458225Demark-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. doi: 10.1016/s0002-8223(97)00133-8.
PubMed 9145091Demark-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. doi: 10.1200/JCO.1993.11.7.1418.
PubMed 8315439Demark-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. doi: 10.1093/ajcn/65.5.1495.
PubMed 9129482Camoriano 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. doi: 10.1200/JCO.1990.8.8.1327.
PubMed 2199619Chlebowski 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. doi: 10.1007/BF01886732.
PubMed 3516262
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Eating Habits and Dysgeusia During Chemotherapy Treatment: a Prospective Cohort Study on Patients Affected by Breast Cancer
- ClinicalTrials.gov ID
- NCT03210441
- Acronym / sponsor ID
- CHANGE / NP2488
- Conditions
- Breast Cancer, Dysgeusia, Eating Behavior, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 6 May 2014 (actual)
- Primary completion
- 6 May 2018 (estimated)
- Study completion
- 6 May 2018 (estimated)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In post-menopause women affected by breast cancer and treated with chemotherapy, overweight and obesity are considered both a risk factors as well as a negative prognostic factors since they increase the risk of early relapse and death. Furthermore, a decrease in weight may also occur during chemotherapy and is associated to a reduced quality of life and survival. Also, the majority of patients under chemotherapy refer dysgeusia, an alteration in taste that can determine food aversion, selection of hypercaloric food or reduced food introduction up to malnutrition. Our aim is to evaluate eating habits changes in patients affected by breast cancer and under chemotherapy treatment and to better understand how this alterations influence the quality of life, anxiety, depression and insomnia of patients as well as overall survival.
Detailed description
INTRODUCTION
Overweight and obesity represent a risk factor for hormone dependent cancers such as breast, endometrium, ovarian, uterine and gastrointestinal cancer.
In particular, overweight and obesity are risk factors for breast cancer in post-menopause women since they are associated to higher level of circulating estrogens, insulin, insulin-like growth factor levels, leptin, adiponectin, growth factors (such as hepatocyte growth factor) and inflammatory cytokines (TNFα and Interleukin-6 (IL-6)). Moreover, they reduce sex hormone binding globulin (SHBG) plasma levels. Overweight and obesity are also negative prognostic factors for breast cancer in post-menopause women since they increase the risk of early relapse and death. An increased weight (2.5-6.2 Kg) is commonly reported during chemotherapy treatment in post-menopause women. This is due to increased appetite, hyperphagia and hydric retention associated with reduced metabolism and physic activities. However, the weight gain during therapy is still not recognised as a negative prognostic factor.
Furthermore, a decrease in weight may also occur during chemotherapy. This is mainly due to lower appetite and early satiety, dysgeusia, nausea and vomiting or intolerance to certain foods. Decreasing weight can determine less efficacy and tolerance in therapy, more complications/infections, more and longer hospitalisations and, as a consequence, a reduced quality of life and survival.
Dysgeusia is an alteration in taste that can determine food aversion, selection of hypercaloric food or reduced food introduction up to malnutrition. More than 75% of patients under chemotherapy refer dysgeusia; this is related to drugs (such as folic acid competitors, cyclophosphamide cisplatin and taxanes) and can last for weeks. ln particular, taxanes determine a peripheral nerves degeneration. The results are a metallic taste and an alteration in salted perception. In addition, they determine a dose-dependent chemotherapy-induced peripheral neuropathy (CIPN) with painful paraesthesia, total areflexia and muscular extremities weakness. Dysgeusia is an underestimated problem. Instrumental examinations and laboratory tests can be useful but they cannot replace a detailed medical history and a close physical examination associated with international validate questionnaires.
At the moment, no agreement was found on chemotherapy-induced dysgeusia prevention and therapy. Patients resolve this problems with cold food, candies before meals and sugary drinks and these behaviours lead to increasing in weight.
STUDY DESIGN
This is a prospective cohort study for the evaluation of eating habits changes and dysgeusia in patients with breast cancer during chemotherapy treatment. It will explore also the potential relations with anxiety, depression, insomnia and quality of life. These evaluations will be actuated using internationally validate questionnaires.
METHODS
This study is based on the collection of data with international validate questionnaires:
- Food frequency questionnaire (FFQ) and photography atlas
- Chemotherapy-induced taste alteration scale (CiTAS): evaluation of changes in taste.
- Functional assessment of cancer therapy (FACT_B): evaluation of quality of life for physical health, social and familiar health, emotional health, functional health and health in relation with the pathology.
- Beck depression inventory (BDI) and HADS: evaluation of depression presence and its intensity.
- Pittsburgh sleep quality index (PSQI) and insomnia severity index (ISI): evaluation of sleep quality.
- State and trait anxiety inventory (STAI-Y): evaluation of anxiety presence and its intensity.
STATISTICAL CONSIDERATIONS
Based on the proportion of the women in overweight before chemotherapy is 30% and the proportion of the women in overweight after chemotherapy is 50% (with a 5% α error and an 80% strength), the established number of patients to include in the study is 186. In prevision of a 10% loss of patients in follow-up, 204 patients will be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients affected by breast cancer and potentially treated with taxane chemotherapy |
| Group 2 | – | –Patients affected by breast cancer and not potentially treated without taxane chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by invasive breast cancer
Key inclusion criteria (2 listed)
- Pre- and post-menopause women with histologic diagnosis of invasive breast cancer surgically treated (all pT and all pN)
- Patients must provide written informed consent to be enrolled in the study
Key exclusion criteria (3 listed)
- Locally extended or metastatic (M1) disease;
- Previous surgical or radio therapeutic treatment (up to one year before the selection) in oral or nasal region;
- Other serious medical conditions that can limit patient capability to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate eating habits changes in patients affected by breast cancer during chemotherapy treatment
Time frame: From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Appearence of dysgeusia, asthenia, diarrhoea, decreased or increased appetite, mucositis, nausea, stypsis, vomiting and meteorism will be evaluated throught Food frequency questionaire (FFQ) compared to baseline (nefore chemotherapy)
7 secondary outcomes
Evaluation of dysgeusia
Time frame: From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of weight alterations
Time frame: From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of eating habits changes
Time frame: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of the impact of eating habits changes and dysgeusia on quality of life
Time frame: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of the impact of eating habits changes and dysgeusia on depression
Time frame: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of the impact of eating habits changes and dysgeusia on insomnia
Time frame: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Evaluation of the impact of eating habits changes and dysgeusia on anxiety, depression
Time frame: from basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- Background: PubMed 21115867Sinicrope 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. No abstract available.
- Background: PubMed 11844838Chlebowski RT, Aiello E, McTiernan A. Weight loss in breast cancer patient management. J Clin Oncol. 2002 Feb 15;20(4):1128-43. doi: 10.1200/JCO.2002.20.4.1128.
- Background: PubMed 2085672Goodwin 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. doi: 10.1007/BF01806329.
- Background: PubMed 8572635Obermair 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.
- Background: PubMed 18757321Litton 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.
- Background: PubMed 8918498Rosner 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. doi: 10.1200/JCO.1996.14.11.3000.
- Background: PubMed 19713014Tredan O, Bajard A, Meunier A, Roux P, Fiorletta I, Gargi T, Bachelot T, Guastalla JP, Lallemand Y, Faure C, Perol 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.
- Background: PubMed 17123151Saquib 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. doi: 10.1007/s10549-006-9442-2. Epub 2006 Nov 23.
- Background: PubMed 14758090Harvie 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. doi: 10.1023/B:BREA.0000014037.48744.fa.
- Background: PubMed 10458225Goodwin 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. doi: 10.1200/JCO.1999.17.1.120.
- Background: PubMed 9145091Demark-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. doi: 10.1016/s0002-8223(97)00133-8.
- Background: PubMed 8315439Demark-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. doi: 10.1200/JCO.1993.11.7.1418.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucia Vassalli, MD contact
Lucia Vassalli, MD principal investigator
Asst Degli Spedali Civili Di Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Dysgeusia, 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 2 inclusion and 3 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 7 Jul 2017. 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 Lucia Vassalli, MD (lucia.vassalli@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate eating habits changes in patients affected by breast cancer during chemotherapy treatment (time frame: From basal visit and after every 3 months (during and post-chemotherapy) up to 12 months post- chemotherapy). 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 NCT03210441, which also lists 38 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 7 Jul 2017.