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Body composition and chemotherapy toxicity in women with early breast cancer (CANDO-3): protocol for an observational cohort study

Body composition and chemotherapy toxicity in women with early breast cancer (CANDO-3): protocol for an observational cohort study
Body composition and chemotherapy toxicity in women with early breast cancer (CANDO-3): protocol for an observational cohort study
Introduction Systemic anticancer therapy is given to
selected patients with early breast cancer (EBC) before or
after surgery with the aim of eradicating micrometastatic
spread and reducing the risk of cancer recurrence.
Chemotherapy treatment is most effective when patients
receive the optimum dose, on time and without delays or
reductions in their treatment doses. Most chemotherapy
drugs are dosed according to body surface area calculated
from a patient’s height and weight. These calculations
were however designed based on data from normal weight
patients. This has resulted in uncertainty as to the optimal
dosing for patients with different amounts of blood,
muscle and fatty tissue (body composition). This study
uses segmental bioelectrical impedance analysis (using
the Seca mBCA 515) to determine whether differences
in the measures of resistance and reactance, and
derived estimates of body composition, are predictive of
chemotherapy toxicity in the treatment of EBC.
Methods and analysis A prospective observational
cohort study of women with EBC in whom adjuvant or
neoadjuvant chemotherapy is planned. A total of 300
participants will be recruited across nine UK hospital
sites. The primary outcome is to determine if higher fat
mass index is associated with increased National Cancer
Institute Common Terminology Criteria for Adverse Events
v5.0 grade 3 (or higher) chemotherapy toxicity.
Ethics and dissemination This study has received
ethical approval from the South Central Hampshire B
Research Ethics Committee, England (19/SC/0596: IRAS:
263666). The chief investigator and coinvestigators will be
responsible for publication of the study findings in a peer-reviewed
journal, on behalf of all collaborators.
Trial registration number ISRCTN79577461.
breast tumours, chemotherapy, nutrition & dietetics, toxicity
2044-6055
Wootton, Stephen
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Durkin, Kesta
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Heetun, Mohammad, Adam
40ba9eee-8ec3-428e-9994-9baae9363864
Ewings, Sean
326656df-c0f0-44a1-b64f-8fe9578ca18a
Munday, Richard
5595543c-3816-40a0-9d63-0b2a3594f55a
Turner, Lesley
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Copson, Ellen
a94cdbd6-f6e2-429d-a7c0-462c7da0e92b
Cutress, Ramsey
68ae4f86-e8cf-411f-a335-cdba51797406
Wootton, Stephen
bf47ef35-0b33-4edb-a2b0-ceda5c475c0c
Durkin, Kesta
3241256e-5543-4dda-9cd4-ab65e04b0dd6
Heetun, Mohammad, Adam
40ba9eee-8ec3-428e-9994-9baae9363864
Ewings, Sean
326656df-c0f0-44a1-b64f-8fe9578ca18a
Munday, Richard
5595543c-3816-40a0-9d63-0b2a3594f55a
Turner, Lesley
5c548bd6-c6b6-4b24-8807-4674e987e390
Copson, Ellen
a94cdbd6-f6e2-429d-a7c0-462c7da0e92b
Cutress, Ramsey
68ae4f86-e8cf-411f-a335-cdba51797406

Wootton, Stephen, Durkin, Kesta, Heetun, Mohammad, Adam, Ewings, Sean, Munday, Richard, Turner, Lesley, Copson, Ellen and Cutress, Ramsey (2022) Body composition and chemotherapy toxicity in women with early breast cancer (CANDO-3): protocol for an observational cohort study. BMJ Open, 12 (2), [e054412]. (doi:10.1136/bmjopen-2021-054412).

Record type: Article

Abstract

Introduction Systemic anticancer therapy is given to
selected patients with early breast cancer (EBC) before or
after surgery with the aim of eradicating micrometastatic
spread and reducing the risk of cancer recurrence.
Chemotherapy treatment is most effective when patients
receive the optimum dose, on time and without delays or
reductions in their treatment doses. Most chemotherapy
drugs are dosed according to body surface area calculated
from a patient’s height and weight. These calculations
were however designed based on data from normal weight
patients. This has resulted in uncertainty as to the optimal
dosing for patients with different amounts of blood,
muscle and fatty tissue (body composition). This study
uses segmental bioelectrical impedance analysis (using
the Seca mBCA 515) to determine whether differences
in the measures of resistance and reactance, and
derived estimates of body composition, are predictive of
chemotherapy toxicity in the treatment of EBC.
Methods and analysis A prospective observational
cohort study of women with EBC in whom adjuvant or
neoadjuvant chemotherapy is planned. A total of 300
participants will be recruited across nine UK hospital
sites. The primary outcome is to determine if higher fat
mass index is associated with increased National Cancer
Institute Common Terminology Criteria for Adverse Events
v5.0 grade 3 (or higher) chemotherapy toxicity.
Ethics and dissemination This study has received
ethical approval from the South Central Hampshire B
Research Ethics Committee, England (19/SC/0596: IRAS:
263666). The chief investigator and coinvestigators will be
responsible for publication of the study findings in a peer-reviewed
journal, on behalf of all collaborators.
Trial registration number ISRCTN79577461.

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e054412.full - Version of Record
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Accepted/In Press date: 26 January 2022
Published date: 22 February 2022
Keywords: breast tumours, chemotherapy, nutrition & dietetics, toxicity

Identifiers

Local EPrints ID: 456307
URI: http://eprints.soton.ac.uk/id/eprint/456307
ISSN: 2044-6055
PURE UUID: fcdfe69e-fcd8-4e91-a303-1de3ce6992f6
ORCID for Sean Ewings: ORCID iD orcid.org/0000-0001-7214-4917

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Date deposited: 27 Apr 2022 02:10
Last modified: 28 Apr 2022 02:02

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Contributors

Author: Stephen Wootton
Author: Kesta Durkin
Author: Mohammad, Adam Heetun
Author: Sean Ewings ORCID iD
Author: Richard Munday
Author: Lesley Turner
Author: Ellen Copson
Author: Ramsey Cutress

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