CancerPhase 1/2NCT05046171
Decreasing Polypharmacy in Older Adults With Curable Cancers Trial
A Phase 1/2 study testing Pharmacist-led deprescribing and Patient education in people with Cancer, run by University of Rochester at 1 site in United States.
Trial summary
This is a single-site cluster-randomized trial to assess efficacy and implementation outcomes of deprescribing interventions in 72 older adults with polypharmacy (PP) and curable cancers initiating chemotherapy. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Pharmacist-led deprescribing and Patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2022to 31 Dec 2025
- Phase
- Phase 1/2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Be age ≥65 years;
- Have a diagnosis of malignancy including aggressive lymphoma or cancers of the breast, gastrointestinal system, genitourinary system, or lung;
- Be initiating chemotherapy, alone or in combination with other systemic antineoplastic agents, (for a period of at least 3 months) within 4 weeks of enrollment;
- Screen positive for polypharmacy (>10 medications) or potentially inappropriate medications
- Be able to read and write English;
- Be able to give informed consent, as determined by the primary oncologist, or has a legally authorized representative to sign consent in the case of cognitive impairment.
Who cannot join
- Be planned to receive a cancer treatment regimen that does not include standard cytotoxic chemotherapy (e.g., only targeted therapies, hormonal therapies, monoclonal antibody therapies, immunotherapy, etc.),
- Have surgery or radiation without concurrent chemotherapy planned within 3 months of consent,
- Have a planned referral to the geriatric oncology clinic (SOCARE) within one month of treatment initiation,
- Lack decisional capacity, if a legally authorized representative is not available to sign consent and participate in study visits and follow-up phone calls.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decreasing Polypharmacy in Older Adults With Curable Cancers: a Pilot Cluster-randomized Trial
This is a single-site cluster-randomized trial to assess efficacy and implementation outcomes of deprescribing interventions in 72 older adults with polypharmacy (PP) and curable cancers initiating chemotherapy. Oncologists (as the cluster) will enroll 6 patients each and will be randomized to either a pharmacist-led deprescribing intervention or patient education intervention. Initial focus groups with oncologists, nurses, pharmacists, primary care physicians, and patients will provide data for initial adaptations to the pharmacist-led intervention arm, and 8 patients will be enrolled as a pre-trial cohort to further refine and adapt the pharmacist-led intervention.
Read the detailed description
Polypharmacy (PP), or the concurrent use of multiple medications, affects up to 92% of older adults with cancer. It has been associated with adverse outcomes in these patients including poor adherence to and tolerance of cancer therapy, decrease in physical functioning, unplanned hospitalizations, falls, increased symptoms, and lower survival. "Deprescribing," or the planned discontinuation of medications which may be potentially unsafe or inappropriate, is an intervention strategy which has the potential to decrease PP and improve outcomes. Deprescribing has not been studied in older adults with cancer receiving chemotherapy. The proposed study will adapt and refine potentially scalable deprescribing interventions, investigate the effects of deprescribing interventions on relative dose intensity and other adverse outcomes in older adults undergoing curative-intent chemotherapy, and identify barriers and facilitators of deprescribing interventions for patients, oncologists, and pharmacists. Focus groups and interviews with pharmacists, oncologists, nurses, primary care providers, and patient advocates will allow initial adaptation of the proposed interventions. A "pre-pilot" cohort of 8 patients with PP and cancer planned to receive curative-intent chemotherapy will undergo a pharmacist-led deprescribing intervention with additional iterative adaptations. Then, 72 patients will be allocated to a pharmacist-led deprescribing intervention versus patient education intervention in a cluster-randomized trial of 12 oncologist clusters.
- Conditions
- Cancer
- Being tested
- Pharmacist-led deprescribing, Patient education
- Keywords
- Older Adults, Cancer receiving chemotherapy, Polypharmacy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-led deprescribingOther
A pharmacist recruited onto the study will review the patient's current medication list and develop a list of targeted recommendations for deprescribing using the 3-step potentially inappropriate medications identification method.
Patient educationOther
Subjects receive a written pamphlet about deprescribing.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Pharmacist-led deprescribing intervention | Experimental | Pharmacists will complete a comprehensive medication assessment with the participant via telemedicine and discuss tailored recommendations for discontinuations of potentially inappropriate medications. The pharmacist will document the evaluation and recommendations and communicate to the participant and care team members. The pharmacist will telephone each participant at least one time after the initial intervention to assess adherence to instructions and recommendations, and to assess any symptoms potentially related to medication discontinuation. Receives: Other: Pharmacist-led deprescribing |
| Arm 2: Patient education brochure | Active comparator | Participants will receive a brochure discussing medication appropriateness and deprescribing in general terms Receives: Other: Patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change between arms in Relative dose intensity (RDI) of chemotherapy
Relative dose intensity (RDI) of chemotherapy, based upon standard dosing from National Comprehensive Cancer Network guidelines or similar reference. RDI assesses the proportion of planned therapy that the patient receives within 12 weeks of initiation of chemotherapy.
Measured: 12 Weeks
Secondary outcomes (6)
Change between arms in Changes in functional status
Changes in functional status, based on Instrumental Activities of Daily Living (IADL)
Measured: 12 Weeks
Change between arms in Changes in functional status
Changes in functional status, based on Activities of Daily Living (ADL)
Measured: 12 Weeks
Change between arms in Grade 3-5 chemotherapy toxicity
Grade 3-5 chemotherapy toxicity based on Common Terminology Criteria for Adverse Events (CTCAE) v.5
Measured: 12 Weeks
Hospitalizations
assessed as ≥1 or 0
Measured: 12 Weeks
Patient-reported falls
assessed as ≥1 or 0
Measured: 12 Weeks
Patient-reported symptoms
Patient-reported symptoms, assessed by selected elements of the NCI Patient Reported Outcomes CTCAE (PRO-CTCAE, 10-20 items).
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start14 Jun 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Erika Ramsdale, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046171
- Sponsor's protocol ID
- UMLT19186
- Other IDs
- K08CA248721
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2021
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ramsdale E, Mohamed M, Holmes HM, Zubkoff L, Bauer J, Norton SA, Mohile S. Decreasing polypharmacy in older adults with cancer: A pilot cluster-randomized trial protocol. J Geriatr Oncol. 2024 Mar;15(2):101687. doi: 10.1016/j.jgo.2023.101687. Epub 2024 Feb 1.
PubMed 38302299Ramsdale E, Malhotra A, Holmes HM, Zubkoff L, Wang J, Mohile S, Norton SA, Duberstein PR. Emotional barriers and facilitators of deprescribing for older adults with cancer and polypharmacy: a qualitative study. Support Care Cancer. 2023 Oct 17;31(12):636. doi: 10.1007/s00520-023-08084-9.
PubMed 37847423
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Polypharmacy in Older Adults With Curable Cancers: a Pilot Cluster-randomized Trial
- ClinicalTrials.gov ID
- NCT05046171
- Acronym / sponsor ID
- UMLT19186
- Conditions
- Cancer
- Keywords
- Older Adults, Cancer receiving chemotherapy, Polypharmacy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 16 Sep 2021 (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 single-site cluster-randomized trial to assess efficacy and implementation outcomes of deprescribing interventions in 72 older adults with polypharmacy (PP) and curable cancers initiating chemotherapy. Oncologists (as the cluster) will enroll 6 patients each and will be randomized to either a pharmacist-led deprescribing intervention or patient education intervention. Initial focus groups with oncologists, nurses, pharmacists, primary care physicians, and patients will provide data for initial adaptations to the pharmacist-led intervention arm, and 8 patients will be enrolled as a pre-trial cohort to further refine and adapt the pharmacist-led intervention.
Detailed description
Polypharmacy (PP), or the concurrent use of multiple medications, affects up to 92% of older adults with cancer. It has been associated with adverse outcomes in these patients including poor adherence to and tolerance of cancer therapy, decrease in physical functioning, unplanned hospitalizations, falls, increased symptoms, and lower survival. "Deprescribing," or the planned discontinuation of medications which may be potentially unsafe or inappropriate, is an intervention strategy which has the potential to decrease PP and improve outcomes. Deprescribing has not been studied in older adults with cancer receiving chemotherapy. The proposed study will adapt and refine potentially scalable deprescribing interventions, investigate the effects of deprescribing interventions on relative dose intensity and other adverse outcomes in older adults undergoing curative-intent chemotherapy, and identify barriers and facilitators of deprescribing interventions for patients, oncologists, and pharmacists. Focus groups and interviews with pharmacists, oncologists, nurses, primary care providers, and patient advocates will allow initial adaptation of the proposed interventions. A "pre-pilot" cohort of 8 patients with PP and cancer planned to receive curative-intent chemotherapy will undergo a pharmacist-led deprescribing intervention with additional iterative adaptations. Then, 72 patients will be allocated to a pharmacist-led deprescribing intervention versus patient education intervention in a cluster-randomized trial of 12 oncologist clusters.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Pharmacist-led deprescribing intervention | Experimental | Other: Pharmacist-led deprescribingPharmacists will complete a comprehensive medication assessment with the participant via telemedicine and discuss tailored recommendations for discontinuations of potentially inappropriate medications. The pharmacist will document the evaluation and recommendations and communicate to the participant and care team members. The pharmacist will telephone each participant at least one time after the initial intervention to assess adherence to instructions and recommendations, and to assess any symptoms potentially related to medication discontinuation. |
| Arm 2: Patient education brochure | Active comparator | Other: Patient educationParticipants will receive a brochure discussing medication appropriateness and deprescribing in general terms |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Be age ≥65 years;
- Have a diagnosis of malignancy including aggressive lymphoma or cancers of the breast, gastrointestinal system, genitourinary system, or lung;
- Be initiating chemotherapy, alone or in combination with other systemic antineoplastic agents, (for a period of at least 3 months) within 4 weeks of enrollment;
- Screen positive for polypharmacy (>10 medications) or potentially inappropriate medications
- Be able to read and write English;
Key exclusion criteria (4 listed)
- Be planned to receive a cancer treatment regimen that does not include standard cytotoxic chemotherapy (e.g., only targeted therapies, hormonal therapies, monoclonal antibody therapies, immunotherapy, etc.),
- Have surgery or radiation without concurrent chemotherapy planned within 3 months of consent,
- Have a planned referral to the geriatric oncology clinic (SOCARE) within one month of treatment initiation,
- Lack decisional capacity, if a legally authorized representative is not available to sign consent and participate in study visits and follow-up phone calls.
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 |
|---|---|---|
| Pharmacist-led deprescribingA pharmacist recruited onto the study will review the patient's current medication list and develop a list of targeted recommendations for deprescribing using the 3-step potentially inappropriate medications identification method. | Other | Arm 1: Pharmacist-led deprescribing intervention |
| Patient educationSubjects receive a written pamphlet about deprescribing. | Other | Arm 2: Patient education brochure |
Primary outcome
Change between arms in Relative dose intensity (RDI) of chemotherapy
Time frame: 12 Weeks
Relative dose intensity (RDI) of chemotherapy, based upon standard dosing from National Comprehensive Cancer Network guidelines or similar reference. RDI assesses the proportion of planned therapy that the patient receives within 12 weeks of initiation of chemotherapy.
6 secondary outcomes
Change between arms in Changes in functional status
Time frame: 12 Weeks
Change between arms in Changes in functional status
Time frame: 12 Weeks
Change between arms in Grade 3-5 chemotherapy toxicity
Time frame: 12 Weeks
Hospitalizations
Time frame: 12 Weeks
Patient-reported falls
Time frame: 12 Weeks
Patient-reported symptoms
Time frame: 12 Weeks
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 19 Aug 2026.
- Derived from this study: PubMed 38302299Ramsdale E, Mohamed M, Holmes HM, Zubkoff L, Bauer J, Norton SA, Mohile S. Decreasing polypharmacy in older adults with cancer: A pilot cluster-randomized trial protocol. J Geriatr Oncol. 2024 Mar;15(2):101687. doi: 10.1016/j.jgo.2023.101687. Epub 2024 Feb 1.
- Derived from this study: PubMed 37847423Ramsdale E, Malhotra A, Holmes HM, Zubkoff L, Wang J, Mohile S, Norton SA, Duberstein PR. Emotional barriers and facilitators of deprescribing for older adults with cancer and polypharmacy: a qualitative study. Support Care Cancer. 2023 Oct 17;31(12):636. doi: 10.1007/s00520-023-08084-9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pharmacist-led deprescribing and Patient education in people with Cancer, run by University of Rochester at 1 site in United States.
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 6 inclusion and 4 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 19 Aug 2026. 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change between arms in Relative dose intensity (RDI) of chemotherapy (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05046171, which also lists 2 linked publications.
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 19 Aug 2026.