NCT07063706

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

2.1 years

First QC Date

June 25, 2025

Last Update Submit

July 15, 2025

Conditions

Cancer ColorectalCancer GiCapecitabinePharmaceutical ServicesAdverse Drug Reaction (ADR)

Keywords

capecitabinepharmaceutical servicesquality of lifeadverse effects

Outcome Measures

Primary Outcomes (1)

  • 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

    Up to 6 months

Secondary Outcomes (1)

  • Pharmaceutical interventios

    Up to 6 months

Study Arms (2)

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.

Other: Pharmaceutical Care

Interventions

Pharmaceutical CareOTHER

Participants in the intervention group received pharmaceutical care

Pharmaceutical care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Cancer

Rio de Janeiro, Rio de Janeiro, 20231-030, Brazil

Location

MeSH Terms

Conditions

Colonic NeoplasmsGastrointestinal NeoplasmsDrug-Related Side Effects and Adverse Reactions

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • CAMILLE C NIGRI, PhD

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR

  • THAISA A NOGUEIRA, PhD

    Universidade Federal Fluminense

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2025

First Posted

July 14, 2025

Study Start

March 1, 2022

Primary Completion

March 31, 2024

Study Completion

August 30, 2024

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

5.204.291

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
June 2025 - June 2029.
Access Criteria
Results

Locations

BR(1)