Clinical trial · Interventional
Endocrinological Changes Due to Pre-medications of Chemotherapy in Patients With Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Treatment for patients with high-risk breast cancer diagnoses is based on chemotherapy drugs with side effects. Dexamethasone is a drug that is part of the arsenal of pre-chemotherapy medications to prevent adverse events resulting from treatment, however common endocrine pathological conditions resulting from high doses of this corticoid are clinically evident in these individuals. The aim of this study is to evaluate the omission of corticosteroid doses as a pre-medication in cancer treatment after the second week of treatment with taxane in a curative setting.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control group | Other | — | UNRESOLVED |
| Drug omission | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EXPERIMENTAL GROUP
- description
- In the experimental group, dexamethasone will be omitted from the second application of paclitaxel. Pre-chemotherapy with the AC protocol: ondansetron 8mg and dexamethasone 10mg + Pre-chemotherapy with paclitaxel: ranitidine 50mg, ondansetron 8mg, diphenhydramine 50mg.
- interventionNames
- Drug: Drug omission
- type
- ACTIVE_COMPARATOR
- label
- CONTROL GROUP
- description
- Pre-chemotherapy with the AC protocol: ondansetron 8mg and dexamethasone 10mg + Pre-chemotherapy with paclitaxel: ranitidine 50mg, ondansetron 8mg, diphenhydramine 50mg and dexamethasone 10mg.
- interventionNames
- Other: Control group
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients from the oncology services of ICESP and its Osasco unit. * Over 18 years of age. * Diagnosed with breast cancer who will be treated with an ACT Icesp scheme in the setting with curative intent (neoadjuvant and adjuvant). Exclusion Criteria: * Patients with significant cognitive impairment that prevents the questionnaire from being applied. * Patients who are not fluent in Portuguese, or illiterate, who did not sign the ICF. * ECOG 3 and KPS \<70%. * Metastatic patients, with the presence of other important morbidities that may interfere with laboratory findings. * Patients with chronic use of steroidal and non-steroidal anti-inflammatory drugs.
References
Publications (1)
- DERIVEDScontre VA, Toyoshima MTK, Estevez-Diz MDP. Pharmacologic de-escalation of dexamethasone during weekly paclitaxel: a randomized phase III trial evaluating safety, endocrine effects, and quality of life. Cancer Chemother Pharmacol. 2026 Jul 13;96(1):75. doi: 10.1007/s00280-026-04920-x. PMID 42439956