Clinical trial · Interventional
Optimizing the Management of Patients With Oral Therapy
Optimizing the Management of Patients With Oral Therapy: a Randomized Trial Evaluating the Impact of Management on the Occurrence of Side Effects
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Following an insufficient recruitment, the sponsor decided to halt prematurely inclusions
Summary
Brief summary (as posted)
Oral anticancer treatments account a quarter of cancer treatments. These oral treatments are allowed at home, avoid hospitalization and limit the use of central venous routes. Oral treatments cause many side effects and patients are reluctant to report them because they are afraid that their treatment will be changed. But when these side effects are poorly managed, they can reduce adherence to treatment. The main hypothesis of this randomized study is that the combination of an initial consultation with a trio (nurse, doctor, pharmacist) and a weekly telephone nurse follow-up during the administration of oral anticancer treatments decreases the rate and duration of side effects. The main objective is to evaluate the impact at 3 months of a optimized management by an initial consultation with a trio nurse, doctor, pharmacist and a weekly nurse telephone follow-up versus a standard management on the level of digestive, skin and mucosal side effects of grade 3 in patients with oral chemotherapy. This randomized study is realized in patients with kidney or breast cancer.
Conditions
Conditions (2)
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 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| managment of oral therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- accented follow-up
- description
- Initial consultation with a trio oncologist / pharmacist / nurse; weekly telephone follow-up with a nurse between each treatment and follow-up visit with the oncologist at each renewal of treatment.
- interventionNames
- Other: managment of oral therapy
- type
- NO_INTERVENTION
- label
- standard follow-up
- description
- Initial consultation with the oncologist and follow-up visit with the oncologist
Primary outcomes (1)
- measure
- Rate of side effects
- timeFrame
- 6 months
- description
- Side effects evaluated: digestive, cutaneous and mucosal grade 3 and 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient over 18 years old. 2. Men or women with kidney cancer treated with Sutent® chemotherapy (Cohort 1) according to the following schedule: 42-day course: 28 days of treatment + 14 days of break therapeutic) 3. Women with breast cancer treated with Xeloda® (Cohort 2) chemotherapy according to the following schedule: 21-day course: 14 days of treatment + 7 days of therapeutic break). 4. Patient (e) able to understand French read, write, speak. 5. Patient who received information about the study. 6. Written and signed consent. 7. Affiliation to a social security scheme. 8. Patient reachable by phone. Exclusion Criteria: 1. Patient under guardianship, curatorship or safeguard of justice. 2. Patient with severe mental retardation impairing comprehension abilities. 3. Impossibility of submitting to the medical follow-up of the test. 4. If hospitalized at the time of inclusion: hospitalization forecast greater than 1 week.
References
Publications (0)
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