Effects of Chemotherapy on the Concentration of Minerals in Hair

Cancer Clinical Trial

Official title:

Effects of Chemotherapy on the Concentration of Minerals in Hair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04039425
• Other study ID #: 5190216
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: April 27, 2020

Study information

• Verified date: April 2020
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 27, 2020
• Est. primary completion date: April 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)