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Effects of Chemotherapy on the Concentration of Minerals in Hair

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ClinicalTrials.gov Identifier: NCT04039425
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
Edward Bitok, Loma Linda University

Brief Summary:
The purpose of the investigator's graduate student research study is to investigate if there are significant changes in hair mineral levels in cancer patients undergoing chemotherapy.

Condition or disease Intervention/treatment
Cancer Procedure: Hair cut

Detailed Description:

Visit 1 - Before the start of chemotherapy

  • Complete a questionnaire about demographics, health, and diet.
  • Weight and height will be measured.
  • A small sample of the participant's hair will be collected from the back side of the head near the base of the neck. Only the hair in the first inch closest to the scalp will be included in the sample. This hair sample will weigh 0.25g to 1g, which is about the same weight as one to two regular paper clips.
  • The participant will be given a food frequency questionnaire

Visit 2- Approximately 2 months after start of chemotherapy

  • The participant will complete a questionnaire about their health and diet.
  • weight and height will be measured
  • A small sample of the participant's hair will be collected from the back side of the head near the base of the neck. Only the hair in the first inch closest to the scalp will be included in the sample. This hair sample will weigh 0.25g to 1g, which is about the same weight as one to two regular paper clips.
  • The participant will be given a food frequency questionnaire.

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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Chemotherapy on the Concentration of Minerals in Hair
Actual Study Start Date : November 1, 2019
Actual Primary Completion Date : April 27, 2020
Actual Study Completion Date : April 27, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Group/Cohort Intervention/treatment
cancer patient
  • Recently diagnosed cancer stage 1, 2, or 3
  • Assigned to receive immunosuppressive chemotherapy treatment
  • Natural hair that has not been dyed or permed in the past 3 months
Procedure: Hair cut
Use only head hair. Cut samples of hair from back of head (see illustration). Cut hair as close to the scalp as possible. As each piece of hair is cut from the head, save only 3.7 square inches of hair closest to the scalp. According to the Doctors Data Lab, this amount is about enough hair to fill a tablespoon. Cut off and discard the rest. Place the saved hair on the scale. Keep cutting and adding hair to the scale until it tips. Hair collection will be about the weight of one to two paper clips (about 3800 strands). Remove the hair on the scale and put it in the plastic bag. Label the plastic bag with the patient's unique random identification and the date collected. Put the hair into the plastic bag, seal, and send to The Doctor's Data Lab.




Primary Outcome Measures :
  1. hair mineral levels(ug/g) [ Time Frame: change between visit 1(baseline/start of chemotherapy) and visit 2 (about 2 months after visit 1) ]
    Mineral levels such as calcium, magnesium, manganese, lead, iron, copper, cobalt, and chromium will be tested. All mineral levels are in ug/g.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects diagnosed with any type of cancer, Stages 1, 2 or 3, assigned to receive immunosupressive chemotherapy treatment.
Criteria

Inclusion Criteria:

  • Are 18 years and older
  • Recently diagnosed cancer stage 1, 2, or 3
  • Assigned to receive immunosuppressive chemotherapy treatment
  • Natural hair that has not been dyed or permed in the past 3 months

Exclusion Criteria:

• Prior chemotherapy treatment for cancer


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039425


Locations
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United States, California
Loma Linda University
Loma Linda, California, United States, 92350
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Edward Bitok, DrPH Loma Linda University
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Responsible Party: Edward Bitok, Assistant Professor, Department of Nutrition and Dietitics, Loma Linda University
ClinicalTrials.gov Identifier: NCT04039425    
Other Study ID Numbers: 5190216
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No