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NCT05935891 · ClinicalTrials.gov registry record · Early Phase 1
A Feasibility Study of Topical Cannabinoids for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS) in Adults With Hormone Receptor-Positive Breast Cancer (CanAroma)
A Early Phase 1 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 24
- Enrollment target
NCT05935891 is a Early Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 24 participants.
The verdict
NCT05935891, a Early Phase 1 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Aromatase inhibitors (AIs) are commonly used for post-menopausal women with hormone-positive breast cancer. Compared to tamoxifen, AIs improve breast cancer recurrence rates and lower 10-year breast cancer mortality. Unfortunately, nearly 2 out of 3 women with estrogen-receptor positive breast cancer treated with AIs experiences AIMSS, such as arthralgia, joint stiffness, and bone pain, and 30% of women with AIMSS report severe pain. AIMSS leads to poor adherence with therapy and discontinuation of therapy in up to 20% of patients. Despite the large number of women affected, current therapeutic interventions have shown only limited efficacy in improving AIMSS. Therefore, the presence of AIMSS may negatively impact breast cancer recurrence and survival. In this current trial, the plan is to utilize topical cannabinoid creams from Vireo Health that have been tested for potency and purity. Two distinct products with different THC/CBD ratios will be provided to patients at no cost; a) a THC-dominant cream (Red XS Balm with 375mg/jar and \<20mg of CBD) and b) a CBD-dominant cream (Violet Balm with 2210mg CBD/jar and \<0.3% THC). The study will explore the feasibility of doing larger, placebo controlled trials by first ensuring adequate patient interest, acceptable tolerability/safety of cream utilization, and preliminary efficacy measures. All patients completing assessments through day 14 will be allowed to choose either Red XS or Violet creams for an additional 2-week extension period.
Interventions
- DRUG CBD-dominant
- DRUG THC dominant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-02-09 |
| Est. Completion | 2024-04-29 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05935891
The ClinicalTrials.gov registry entry for NCT05935891 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which CBD-dominant is the first listed.
NCT05935891 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05935891 about?
NCT05935891 is a clinical study titled "A Feasibility Study of Topical Cannabinoids for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS) in Adults With Hormone Receptor-Positive Breast Cancer (CanAroma)". Aromatase inhibitors (AIs) are commonly used for post-menopausal women with hormone-positive breast cancer. Compared to tamoxifen, AIs improve breast cancer recurrence rates and lower 10-year breast cancer mortality. Unfortunately, nearly 2 out of 3 women with estrogen-receptor positive breast cance...
What is the current status of trial NCT05935891?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 24 participants. The study started on 2023-02-09. Estimated completion is 2024-04-29.
What interventions are being tested in trial NCT05935891?
The interventions under investigation include: CBD-dominant (DRUG), THC dominant (DRUG).
Who is sponsoring clinical trial NCT05935891?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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