Evidence map›Paper›PMID 40751295›Full record

Trial reportCancer medicine2025

Pilot Study of Cannabidiol for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Breast Cancer.

Nicole M G Fleege, Elise A Miller, Kelley M Kidwell, Zeb R Zacharias, Jon Houtman, Kelly Scheu, Kathleen Kemmer, Kevin F Boehnke, N Lynn Henry

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04754399 (Phase 2 Trial of Cannabidiol), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04754399 phase2completednot on this map

Phase 2 Trial of Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias

TypeinterventionalSponsorUniversity of Michigan Rogel Cancer CenterRan2021 to 2023Enrolled40ConditionsArthralgia, Breast CancerArmsCannabidiol (CBD)
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Nicole M G FleegeUniversity of Michigan Medical School, Ann Arbor, Michigan, USA.ORCID https://orcid.org/0000-0001-9268-7070
Elise A MillerDepartment of Biostatistics, University of Michigan School of Public Health, Ann Arbor, Michigan, USA.
Kelley M KidwellDepartment of Biostatistics, University of Michigan School of Public Health, Ann Arbor, Michigan, USA.
Zeb R ZachariasHuman Immunology Core, Holden Comprehensive Cancer Center, Iowa City, Iowa, USA.
Jon HoutmanHuman Immunology Core, Holden Comprehensive Cancer Center, Iowa City, Iowa, USA.ORCID https://orcid.org/0000-0002-5307-9854
Kelly ScheuUniversity of Michigan Medical School, Ann Arbor, Michigan, USA.
Kathleen KemmerUniversity of Michigan Medical School, Ann Arbor, Michigan, USA.
Kevin F BoehnkeUniversity of Michigan Medical School, Ann Arbor, Michigan, USA.
N Lynn HenryUniversity of Michigan Medical School, Ann Arbor, Michigan, USA.ORCID https://orcid.org/0000-0002-4771-5930

Funding

Viral VectorP30CA086862 · NCI · UNIVERSITY OF IOWA · PI Jon C.D. Houtman · 2000 to 2026
$70.0M
Michigan Institute for Clinical and Health Research (MICHR)UM1TR004404 · NCATS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Julie C Lumeng · 2023 to 2026
$39.8M
Conquer Cancer FoundationNCATS NIH HHS UM1 TR004404NIH HHS P30CA086862NIH HHS UM1TR004404Rising Tide Foundation for Clinical Cancer Research
6 · The paper itself

Abstract

introductionAromatase inhibitor (AI) therapy reduces breast cancer recurrence risk. However, some patients stop treatment early because of AI-associated musculoskeletal symptoms (AIMSS). AIMSS is due in part to systemic inflammation. Cannabidiol (CBD) has anti-nociceptive and anti-inflammatory properties, making it a potential treatment option for AIMSS.

methodsWomen with stage 0-3 hormone receptor-positive breast cancer experiencing AIMSS enrolled in this phase 2 clinical trial. Patients received CBD (Epidiolex), titrated over 4 weeks to 100 mg BID, for a total of 15 weeks. Patient-reported outcomes were collected serially. The primary endpoint was the number of patients with at least a 2-point reduction in worst pain from baseline to 15 weeks. Statistical analysis was completed using paired t-tests and linear mixed models.

resultsOf 39 eligible patients, 28 completed protocol-directed study treatment. Eleven discontinued treatment due to toxicity (n = 5) or per patient preference (n = 6). Seventeen of 39 patients met the primary endpoint (43.6%, 95% CI [28%, 60%]). Worst pain improved 0.13 per week of treatment (p < 0.001) for all patients; average improvement in worst pain was 1.95 points at the end of 15 weeks. Of the 28 patients who completed the study, average reduction in worst pain was 2.36 points (95% CI [-3.22, -1.49]) between baseline and Week 15.

conclusionTreatment with CBD was safe, tolerable, and associated with improvement in joint pain for a subset of patients. Additional studies are needed to further understand the impact of CBD on AIMSS and which patients are most likely to benefit from CBD treatment.

trial registrationwww. CLINICALTRIALS: gov: NCT04754399.

Indexed as

Aromatase InhibitorsBreast NeoplasmsCannabidiolMusculoskeletal DiseasesAdultAgedFemaleHumansMiddle AgedPatient Reported Outcome MeasuresPilot ProjectsTreatment OutcomeAromatase InhibitorsCannabidiolaromatase inhibitor associated musculoskeletal symptomsbreast cancercannabidiolcannabisclinical trialendocrine therapyquality of lifesupportive care

Identifiers

PMID40751295
PMCPMC12316815

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.