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Completed

NCT Number: NCT04039425

Effects of Chemotherapy on the Concentration of Minerals in Hair

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Loma Linda University

Loma Linda, California, 92350, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hair cut

Procedure

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 31, 2019
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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