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OpenTrials
Completed

NCT Number: NCT07063706

Pharmaceutical Care for Patients Using Capecitabine

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharmaceutical care

Other

Participants in the intervention group received pharmaceutical care

Primary outcomes

  1. Instruments and questionnaire

    Time frame: Up to 6 months

    Assessment of the clinical benefits of pharmaceutical care, measured by the variation in participants' quality of life between the beginning and end of treatment with capecitabine

Secondary outcomes

  1. Pharmaceutical interventios

    Time frame: Up to 6 months

    Number of pharmaceutical interventions performed

Sponsors and collaborators

Lead sponsor

Faculdade de Farmácia

Other

Collaborators

  • Instituto Nacional de Cancer, Brazil
  • Universidade Federal Fluminense
  • Universidade Federal do Rio de Janeiro

Registry information

Official study title

Impact of Pharmaceutical Care on Patients Using Capecitabine: a Multicenter Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 14, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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