Cancer ColorectalNCT07063706
Pharmaceutical Care for Patients Using Capecitabine
A study testing Pharmaceutical Care in people with Cancer Colorectal and Cancer Gi, run by Faculdade de Farmácia at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Colorectal, Cancer Gi, Capecitabine
- What is being tested?
- Pharmaceutical Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2022to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Nacional de Cancer
Rio de Janeiro, Rio de Janeiro, 20231-030
About this study
Official title: Impact of Pharmaceutical Care on Patients Using Capecitabine: a Multicenter Randomized Clinical Trial
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.
Read the detailed 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.
- Conditions
- Cancer Colorectal, Cancer Gi, Capecitabine, Pharmaceutical Services, Adverse Drug Reaction (ADR)
- Being tested
- Pharmaceutical Care
- Keywords
- capecitabine, pharmaceutical services, quality of life, adverse effects
- Medical subject headings
- Colonic Neoplasms, Gastrointestinal Neoplasms, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical CareOther
Participants in the intervention group received pharmaceutical care
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants in the control group received pharmaceutical guidance at the time of dispensing capecitabine. |
| Pharmaceutical care | Active comparator | Participants in the intervention group received pharmaceutical care. Receives: Other: Pharmaceutical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Instruments and questionnaire
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
Measured: Up to 6 months
Secondary outcomes (1)
Pharmaceutical interventios
Number of pharmaceutical interventions performed
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Mar 2022
- Primary completion31 Mar 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ColorectalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants in the control group received pharmaceutical guidance at the time of dispensing capecitabine and participants in the intervention group received pharmaceutical care through consultations carried out on the dates scheduled for collection of capecitabine at the pharmacy.
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Farmácia
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal Fluminense, Instituto Nacional de Cancer, Brazil, Universidade Federal do Rio de Janeiro
- Responsible party
- Sponsor
- Investigators
- CAMILLE C NIGRI, PhD, Principal investigator, Universidade Federal do Rio de JaneiroTHAISA A NOGUEIRA, PhD, Study chair, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063706
- Sponsor's protocol ID
- 5.204.291
- Other IDs
- 5.313.716, 5.855.089
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 5.204.291
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pharmaceutical Care on Patients Using Capecitabine: a Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07063706
- Acronym / sponsor ID
- 5.204.291
- Conditions
- Cancer Colorectal, Cancer Gi, Capecitabine, Pharmaceutical Services, Adverse Drug Reaction (ADR)
- Keywords
- capecitabine, pharmaceutical services, quality of life, adverse effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Faculdade de FarmáciaUniversity, hospital or other
- Collaborators
- Universidade Federal Fluminense, Instituto Nacional de Cancer, Brazil, Universidade Federal do Rio de Janeiro
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants in the control group received pharmaceutical guidance at the time of dispensing capecitabine and participants in the intervention group received pharmaceutical care through consultations carried out on the dates scheduled for collection of capecitabine at the pharmacy.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants in the control group received pharmaceutical guidance at the time of dispensing capecitabine. |
| Pharmaceutical care | Active comparator | Other: Pharmaceutical CareParticipants in the intervention group received pharmaceutical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmaceutical CareParticipants in the intervention group received pharmaceutical care | Other | Pharmaceutical care |
Primary outcome
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
1 secondary outcome
Pharmaceutical interventios
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: Yes. 5.204.291
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CAMILLE C NIGRI, PhD principal investigator
Universidade Federal do Rio de Janeiro
THAISA A NOGUEIRA, PhD study chair
Universidade Federal Fluminense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical Care in people with Cancer Colorectal and Cancer Gi, run by Faculdade de Farmácia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Instruments and questionnaire (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.