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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Edward Bitok, DrPH, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): April 27, 2020
• Study Completion (Actual): April 27, 2020

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: July 29, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 5190216

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No