An observational cohort study of toxicity in female patients treated for early breast cancer with Adriamycin and Cyclophosphamide chemotherapy.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12607000464460

Enrollment

165

Registered

2007-09-13

Start date

2007-09-10

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to help determine whether chemotherapy doses can be better adjusted for different body sizes and compositions. Chemotherapy doses are normally adjusted to match a patient’s size. There is concern It is thought that when dosing larger people in this way, they might experience more side effects from chemotherapy because of the bigger chemotherapy doses. Therefore many doctors around the world, including those at this institution, will keep chemotherapy doses below a certain maximum threshold. However some international studies have shown no increased side effects from giving larger people bigger doses of chemotherapy. This study will try to determine if there is any difference in side effects for patients of different body size when dosed in the usual manner with a maximum dose threshold in place.

Interventions

Observational - rates of toxicity related treatment modification will be observed over four cycles of Adriamycin and Cyclophosphamide chemotherapy in three cohorts of patients - capped dose (body surface area >2m2), uncapped and obese (BSA < 2m2, body mass index >30), and uncapped and non-obese (BSA<2m2, BMI<30).

Eligibility

Sex/Gender

All

Age

18 Years to -2147483648 No limit

Healthy volunteers

Inclusion criteria

Age = 18 years. Female patients receiving Adriamycin (60mg/m2) and Cyclophosphamide (600mg/m2) chemotherapy for early breast cancer in the study institution(s). Adequate pre-treatment bone marrow function defined as absolute neutrophil count = 1.5×106/L , platelet count = 100×109/L. Calculated creatinine clearance by Cockroft-Gault or MDRD (Modification of Diet in Renal Disease) equation of = 60ml/min. Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

Previous exposure to cytotoxic agents or long-term immunosuppression. Patient not willing to have chemotherapy at the study centre(s). Known hypersensitivity to Adriamycin or Cyclophosphamide. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Outcome results