Melatonin Cream Against Acute Radiation Dermatitis in Patients With Early Breast Cancer
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 12% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-01-31, after 2019-04-30 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2021-01-31. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: radiationcancertherapytumorbreast
Phrases that lowered it: dermatitisinvestigateareathe aimaim of -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Primary purpose: prevention (lowers risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Responsible party: sponsor investigator (raises risk) · Design
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Minimum age: 50 (lowers risk) · Who can join
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Drug's FAERS reports with a death: 7.0% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 62.5% (lowers risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
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Disease area, dermatology: Yes (raises risk) · Disease area
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Drug's FAERS reports before start: 18330 (lowers risk) · Drug's FDA history
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 50 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 18330 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4114 (typical: 412.5)
- Drug's FAERS reports marked serious
- 62.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- dimethyl sulfoxide, melatonin
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy NCT02332928 · started 2015 · scored riskier than 75% of active trials terminated
- Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients NCT01042938 · started 2008 · scored riskier than 93% of active trials completed
- Barrier Film vs. Standard Skin Care in Preventing Dermatitis in Women With Breast Cancer Receiving Radiation NCT01762020 · started 2013 · scored riskier than 39% of active trials completed
- Preventive Effect of Boron-based Gel on Radiation Dermatitis NCT04239560 · started 2019 · scored riskier than 24% of active trials completed
- Trial Comparing Calendula Officinalis With Aqueous Cream Essex to Treat Skin Reactions From Radiotherapy of Breast Cancer NCT01688479 · started 2011 · scored riskier than 21% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.