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Study of CoQ10 During One Cycle of Doxorubicin Treatment for Breast Cancer

NCT00976131 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-10-17

No results posted yet for this study

Summary

This research study hopes to examine the effects of Coenzyme Q10 on doxorubicin (Adriamycin) metabolism during breast cancer treatment.

Conditions

Interventions

DRUG

CoQ10

Capsules taken daily for two weeks prior to Cycle 3 chemotherapy infusion OR Capsules taken daily for two weeks prior to Cycle 4 infusion. Dose Level 1: 300mg/d CoQ10 (2 capsules) Dose Level 2: 600mg/d CoQ10 (4 capsules) Dose Level 3: 1200mg/d CoQ10 (8 capsules)

OTHER

CoQ10 Placebo

Capsules taken daily for two weeks prior to Cycle 3 chemotherapy infusion OR Capsules taken daily for two weeks prior to Cycle 4 infusion. Dose Level 1: 300mg/d placebo (2 capsules) Dose Level 2: 600mg/d placebo (4 capsules) Dose Level 3: 1200mg/d placebo (8 capsules)

DRUG

Doxorubicin

Standard of care chemotherapy medication used to treat cancer.

DRUG

Cyclophosphamide

Standard of care chemotherapy medication used to treat cancer.

Sponsors & Collaborators

Principal Investigators

  • Heather Greenlee, ND, PhD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-09-30
Completion
2021-01-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00976131 on ClinicalTrials.gov