NCT04039425

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2020

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

6 months

First QC Date

July 25, 2019

Last Update Submit

April 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

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

Interventions

Hair cutPROCEDURE

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.

cancer patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects diagnosed with any type of cancer, Stages 1, 2 or 3, assigned to receive immunosupressive chemotherapy treatment.

You may qualify if:

  • 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

You may not qualify if:

  • Prior chemotherapy treatment for cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Edward Bitok, DrPH

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Nutrition and Dietitics

Study Record Dates

First Submitted

July 25, 2019

First Posted

July 31, 2019

Study Start

November 1, 2019

Primary Completion

April 27, 2020

Study Completion

April 27, 2020

Last Updated

April 29, 2020

Record last verified: 2020-04

Locations