Effects of Chemotherapy on the Concentration of Minerals in Hair

NCT ID: NCT04039425

Last Updated: 2020-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-04-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Hair cut

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Edward Bitok

Assistant Professor, Department of Nutrition and Dietitics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Edward Bitok, DrPH

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Loma Linda University

Loma Linda, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5190216

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.