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Pharmaceutical Care for Patients Using Capecitabine

F

Faculdade de Farmácia

Status

Completed

Conditions

Pharmaceutical Services
Capecitabine
Adverse Drug Reaction (ADR)
Cancer Gi
Cancer Colorectal

Treatments

Other: Pharmaceutical Care

Study type

Interventional

Funder types

Other

Identifiers

NCT07063706
5.855.089 (Other Identifier)
5.313.716 (Other Identifier)
5.204.291

Details and patient eligibility

About

This is a longitudinal, prospective and intervention study, which will be carried out with patients undergoing treatment with capecitabine, where the impact of pharmaceutical care will be evaluated.

Full description

Pharmaceutical care (PC) is a professional service in which the pharmacist, actively and in direct interaction with the patient, seeks to achieve concrete health results through the use of medications that improve their quality of life, considering their socioeconomic and cultural context. Through the practice of PC, it becomes possible to detect drug-related problems (DRPs), in addition to the possibility of preventing and resolving negative outcomes associated with the drug (NMR). With recent advances in cancer treatment, the increasing use of oral antineoplastic agents has accelerated. Despite the advantages involved in the use of oral chemotherapy compared to intravenous chemotherapy, there are associated risks that can compromise patient safety and the effectiveness of anticancer therapy. PC as a strategy to ensure and promote the safe and rational use of oral antineoplastics has been increasingly used in the care of cancer patients.

This is a longitudinal, prospective, interventional study that will be conducted with patients undergoing treatment with capecitabine. The study will last 30 months, from March 1, 2022 to August 30, 2024. The study will be conducted in two reference centers for oncology treatment in the city of Rio de Janeiro.

Enrollment

176 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients initiating treatment with capecitabine, either: as monotherapy, or in combination with other antineoplastic therapies and/or radiotherapy.
  • No restrictions regarding therapeutic regimen or disease stage.
  • Age 18 years or older.
  • Patients being followed at one or both of the following institutions: Hospital do Câncer I of the National Cancer Institute (INCA), and/or Clementino Fraga Filho University Hospital (UFRJ).

Exclusion criteria

  • Patients who have previously started capecitabine treatment, with more than one full cycle completed prior to enrollment.
  • Inability to communicate verbally or significant difficulty in understanding that prevents adherence to pharmaceutical care instructions.
  • Refusal or inability to sign the Informed Consent Form.
  • Participation in another clinical study that may interfere with outcomes related to pharmaceutical care.
  • Any clinical condition that, in the investigator's judgment, may compromise full participation in the study.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

176 participants in 2 patient groups

Control group
No Intervention group
Description:
Participants in the control group received pharmaceutical guidance at the time of dispensing capecitabine.
Pharmaceutical care
Active Comparator group
Description:
Participants in the intervention group received pharmaceutical care.
Treatment:
Other: Pharmaceutical Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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