- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06818370
The Effect of Coconut Oil on Alopecia
The Effect of Coconut Oil on Alopecia in Women Receiving Doxorubucin-Cycylophosphamide Treatment for Breast Cancer
Study Overview
Detailed Description
Cancer is a disease in which the cells in our body multiply uncontrollably and develop by metastasizing, and the symptoms, course and consequences of the disease can show complex qualities in each patient. Cancer treatments have benefits and harms. One of these side effects is alopecia.
Alopecia due to cancer treatments is a condition of hair loss, partial or complete, usually temporary but rarely permanent.
In chemotherapy-induced alopecia, the hair follicle is damaged due to the pause in the anagen phase and causes the hair to break off spontaneously during activities such as washing and brushing the hair.
Various scales are used in the evaluation of alopecia due to cancer treatments, such as the National Cancer Institute Common Terminology Criteria for Side Effects and the Dean Alopecia Scale.
Some applications are made to prevent and treat alopecia. These include strategies and pharmacological applications to physically reduce the amount of medication given to the hair follicle.
Coconut oil helps regrow damaged hair. It provides essential proteins necessary for hair and softens the scalp and hair.
In the literature, it has been observed that studies showing the effects of coconut oil for the prevention and treatment of alopecia are insufficient. This study will be conducted on 86 breast cancer patients to determine the effect of coconut oil on the development of alopecia.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: İsmail Dakdevir, Nurse
- Phone Number: +905533228416
- Email: dakdevirismail@gmail.com
Study Locations
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Yenimahalle
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Ankara, Yenimahalle, Turkey, 06170
- Recruiting
- Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• To have been diagnosed with breast cancer.
- The chemotherapy treatment plan should be planned as the Doxorubicin-Cyclophosphamide protocol.
- Volunteer to participate in the study.
- Be 18 years of age or older.
- Being a woman.
Exclusion Criteria:
• Having any health problem or disability that prevents communication (vision-hearing problems, neurological, psychiatric diseases).
- Planning other treatments other than the Doxorubicin-Cyclophosphamide protocol for the treatment of breast cancer.
- Not volunteering to participate in the study.
- Having previously experienced any disease/skin problem that causes hair loss.
- Having received chemotherapy before.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
At the beginning of the study,patients will be asked to fill out an individual information form containing demographic information and disease process before the first chemotherapy application.The coconut oil application protocol will be explained to the patients in the experimental group and 10 milliliters of coconut oil will be applied to the hair follicles once a week.
Alopecia assessment will be done every week.
|
The coconut oil application protocol will be explained to the patients in the experimental group and 10 milliliters of coconut oil will be applied to the hair follicles once a week.
Alopecia assessment will be done every week.
|
|
No Intervention: Control Group
At the beginning of the study,patients will be asked to fill out an individual information form containing demographic information and disease process before the first chemotherapy application.
Patients in the control group will be asked not to apply anything to their hair.
In each subsequent week, the presence of hair loss of the patients will be evaluated with the alopecia evaluation scale.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
National Cancer Instute (NCI) Common Terminology Criteria for Adverse Events (CTCAE); Alopecia
Time Frame: 1-12 WEEK
|
Grade 1; 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 Grade 2; Hair loss of >=50% normal for that individual that is readily apparent to others; a wig or hair piece is necessary if the patient desires to completely camouflage the hair loss; associated with psychosocial impact
|
1-12 WEEK
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ankara Onkoloji EAH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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