CancerNCT06566560
The ROAD 2.0 to Sustainable Medication Use: Redispensing Unused Oral Anticancer Drugs
A study testing redispensing oral anticancer drugs in people with Cancer and Oncology, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The goal of this prospective intervention study is to investigate the effectiveness of redispensing unused oral anticancer drugs. The main questions it aims to answer are: What are the cost-savings of redispensing unused oral anticancer drugs? What is the environmental impact of redispensing unused oral anticancer… Read more about this study
- Who is it for?
- Any age
- What is being tested?
- redispensing oral anticancer drugs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Jan 2024to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of all ages
- A clinical diagnosis of cancer using an oral anticancer drug that requires storage at room temperature according to the Summary of Product Characteristics (SmPC).
Who cannot join
- Patients that do not understand the Dutch or English language, in written or spoken.
- Patients receiving prescriptions that contain an amount of tablets that deviates from the regular package size, resulting in the pharmacy dispensing an opened package
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525 GA
Shirley Xie, 0611469114, Shirley.Xie@radboudumc.nl
About this study
Official title: Cost-savings and Environmental Impact Obtained From Redispensing Unused Oral Anticancer Drugs
The goal of this prospective intervention study is to investigate the effectiveness of redispensing unused oral anticancer drugs.
The main questions it aims to answer are:
- What are the cost-savings of redispensing unused oral anticancer drugs?
- What is the environmental impact of redispensing unused oral anticancer drugs?
Researchers will compare redispensing unused oral anticancer drugs to the standard practice of disposal.
Participants will receive their oral anticancer drugs in a sealed bag with a temperature indicator if needed. They will be asked to return any unused oral anticancer drugs to the pharmacy during their next visit to the hospital.
- Conditions
- Cancer, Oncology, Pharmacy, Drug Prescriptions
- Being tested
- redispensing oral anticancer drugs
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
redispensing oral anticancer drugsOther
Participants will receive oral anticancer drugs according to their regular prescriptions, distributed in the original manufacturer's package. Following the guideline, some oral anticancer drug (i.e. requiring temperature storage up to 25C degrees) will be supplemented with a validated temperature indicator (Timestrip Neo, customer configuration), enclosed with a seal bag. Patients are requested to return unused oral anticancer drugs to the outpatient pharmacy that distributed them.
Pharmacy staff will assess the quality of returned oral anticancer drugs, applying the following criteria:
- the seal bag is unopened
- the drug package is unopend and undamaged
- the expiry date is ≥ 3 months
- the medication has not been stored outside the product label storage claim
Oral anticancer drugs that meet all criteria are restocked, and consecutively redispensed to participants visiting the same outpatient pharmacy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Not described Receives: Other: redispensing oral anticancer drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The environmental impact of redispensing unused oral anticancer drugs of verified quality compared to standard practice of disposal.
Environmental impact will be measured in CO2-eq
Measured: From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months
Cost-savings obtained by redispensing unused oral anticancer drugs of verified quality compared to standard practice of disposal.
Cost savings will be measured in euros
Measured: From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months.
Secondary outcomes (3)
The proportion of usability of returned medication for redispensing and the reasons for quality disapproval.
Measured: From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months
The proportion of returned unused oral anticancer drugs and reasons thereof.
Measured: From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months
Patients' reasons for not wanting to participate in a redispensing program for oral anticancer drugs.
Measured: From date of first invitation to participate in the study until the end of the recruitment period, up to 8 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start10 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566560
- Sponsor's protocol ID
- 2020-7049
- Other IDs
- 111109
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-savings and Environmental Impact Obtained From Redispensing Unused Oral Anticancer Drugs
- ClinicalTrials.gov ID
- NCT06566560
- Acronym / sponsor ID
- 2020-7049
- Conditions
- Cancer, Oncology, Pharmacy, Drug Prescriptions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Aug 2024 (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.
The goal of this prospective intervention study is to investigate the effectiveness of redispensing unused oral anticancer drugs.
The main questions it aims to answer are:
- What are the cost-savings of redispensing unused oral anticancer drugs?
- What is the environmental impact of redispensing unused oral anticancer drugs?
Researchers will compare redispensing unused oral anticancer drugs to the standard practice of disposal.
Participants will receive their oral anticancer drugs in a sealed bag with a temperature indicator if needed. They will be asked to return any unused oral anticancer drugs to the pharmacy during their next visit to the hospital.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: redispensing oral anticancer drugs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of all ages
- A clinical diagnosis of cancer using an oral anticancer drug that requires storage at room temperature according to the Summary of Product Characteristics (SmPC).
Key exclusion criteria (2 listed)
- Patients that do not understand the Dutch or English language, in written or spoken.
- Patients receiving prescriptions that contain an amount of tablets that deviates from the regular package size, resulting in the pharmacy dispensing an opened package
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 |
|---|---|---|
| redispensing oral anticancer drugsParticipants will receive oral anticancer drugs according to their regular prescriptions, distributed in the original manufacturer's package. Following the guideline, some oral anticancer drug (i.e. requiring temperature storage up to 25C degrees) will be supplemented with a validated temperature indicator (Timestrip Neo, customer configuration), enclosed with a seal bag. Patients are requested to return unused oral anticancer drugs to the outpatient pharmacy that distributed them. Pharmacy staff will assess the quality of returned oral anticancer drugs, applying the following criteria: 1. the seal bag is unopened 2. the drug package is unopend and undamaged 3. the expiry date is ≥ 3 months 4. the medication has not been stored outside the product label storage claim Oral anticancer drugs that meet all criteria are restocked, and consecutively redispensed to participants visiting the same outpatient pharmacy. | Other | Intervention |
Primary outcome
The environmental impact of redispensing unused oral anticancer drugs of verified quality compared to standard practice of disposal.
Time frame: From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months
Environmental impact will be measured in CO2-eq
Cost-savings obtained by redispensing unused oral anticancer drugs of verified quality compared to standard practice of disposal.
Time frame: From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months.
Cost savings will be measured in euros
3 secondary outcomes
The proportion of usability of returned medication for redispensing and the reasons for quality disapproval.
Time frame: From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months
The proportion of returned unused oral anticancer drugs and reasons thereof.
Time frame: From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months
Patients' reasons for not wanting to participate in a redispensing program for oral anticancer drugs.
Time frame: From date of first invitation to participate in the study until the end of the recruitment period, up to 8 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing redispensing oral anticancer drugs in people with Cancer and Oncology, run by Radboud University Medical Center at 1 site in Netherlands.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Aug 2024. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shirley Xie (0611469114, Shirley.Xie@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The environmental impact of redispensing unused oral anticancer drugs of verified quality compared to standard practice of disposal. (time frame: From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months). The study lists 2 primary outcomes in all. 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 22 Aug 2024.