Vitamin d gel on the scalp: a new hope against chemo hair loss?
NCT ID NCT01588522
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This early-stage trial is testing whether a topical solution containing calcitriol, a form of vitamin D, can safely reduce hair loss in adults receiving taxane-based chemotherapy for breast, gynecologic, or other solid tumors. Participants apply the solution to their scalp twice daily, starting before chemotherapy and continuing for at least three months. Researchers will monitor side effects, measure how much of the drug enters the blood, and track hair loss through photographs and diaries.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a topical solution of calcitriol (a form of vitamin D) applied to the scalp
- What this could lead to
- If safe and effective, this scalp treatment could help prevent or reduce chemotherapy-induced hair loss, improving quality of life for cancer patients.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the treatment may not work or could cause side effects. It is not yet known if it will be effective.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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28 people
The number who actually took part.
- Started
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Sep 2012
- Finished
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Feb 2017
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adult patients at least 18 years of age * Able to fully understand and participate in the informed consent process * Patients who are scheduled to receive a taxane-based regimen for a histologically confirmed solid tumor that is: 1. Early stage and/or treatment naïve, or 2. Relapsed or is refractory to previous therapy, or 3. Operable and necessitates adjuvant or neo-adjuvant treatment * Have no evidence of alopecia or mild alopecia (NCI CTCAE v.4.0 grade 1 alopecia defined as hair loss of \<50% of normal for that individual that is not obvious from a distance but only on close inspection; a different hair style may be required to cover the hair loss but it does not require a wig or hair piece to camouflage). Female/male-pattern baldness or age-related hair loss are allowed if not greater than grade 1, per NCI-CTCAE v. 4.0. Patients that have previously lost their hair may enroll if they currently have Grade 0 or 1 alopecia * Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1 within 14 days prior to registration * Has baseline neutrophil counts of \> 1500 cells/mm3 within 72 hours prior to registration * Has serum calcium less than or equal to upper limit of normal (ULN) (for patients with an albumin lower than 3.0, a corrected calcium serum calcium = serum calcium +\[0.8\]\[3.5-serum albumin\]) within 72 hours prior to registration Exclusion Criteria: * Patients receiving calcium-lowering therapy or drugs that may affect calcium levels (e.g., calcitonin, mithramycin, phosphate, denosumab) within 4 weeks of initiation of topical calcitriol. Patients who have been managed with bisphosphonates or calcium-lowering therapy for 3 months or greater prior to the start of the trial and have demonstrated evidence for stability of calcium metabolism would be considered eligible for participation in the trial. * Has a history of drug or alcohol abuse within 1 year of study enrollment as determined by the investigator. * Patients who elect to shave the scalp hair prior to the initiation of chemotherapy or who plan to do so during the chemotherapy treatment. * Any dermatological condition that in the opinion of the investigator will affect the absorption of the study medication, e.g. Atopic Dermatitis, etc. * Has been treated with an investigational agent within 30 days or six half-lives of its biologic activity whichever is longer, before the start of study. (Patients may not be concurrently enrolled on another trial or concurrently treated with another investigational agent) * Patients with a history of hypercalcemia or vitamin D toxicity, or hospitalization for treatment of angina, myocardial infarction, or congestive heart failure or psychiatric illness currently or within 30 days of study entry as determined by the investigator. * Has a history of significant allergy to calcitriol as determined by the investigator. * Has any condition that interferes with the ability of the subject to understand or comply with the requirements of the study. * Patients taking Vitamin D supplements during the study, unless they have been taking Vitamin D supplements for 30 days or more prior to the start of the study and that the dose of the Vitamin D supplement remain the same throughout the study. * Patients treated with medications that are known to affect calcium levels within 4 weeks of initiation of topical therapy (\>500 IU vitamin A, calcium supplements, fluoride, antiepileptics).with the exception of patients on stable therapy for more than six months * Patients with hypercalcemia or kidney stones * Patients that indicate they have significant hair breakage or hair damage and associated hair loss from hair over-processing within the last 30 days due to peroxide applications, permanent hair coloring, bleaches, streaking, perms, relaxers and/or hair oxidative dyes. * Current alopecia grade 2 or greater as per NCI-CTCAE v.4.0, or significant hair loss or hair breakage * Prior radiation to the cranium * Pregnant or breastfeeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, 10022, United States
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Samuel Oschin Comprehensive Cancer Institute Cedars-Sinai
Los Angeles, California, 90048, United States
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