Breast CancerPhase 1CoQ10NCT00096356
Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer
A Phase 1 study testing CoQ10 & Vitamin E in people with Breast Cancer and Fatigue, run by Wake Forest University Health Sciences at 31 sites in United States.
Trial summary
RATIONALE: Coenzyme Q10 is a vitamin that may be effective in relieving fatigue and depression in women who are undergoing chemotherapy for breast cancer. PURPOSE: This randomized clinical trial is studying how well coenzyme Q10 works in relieving treatment-related fatigue in women with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Fatigue
- What is being tested?
- CoQ10 & Vitamin E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 31 sitesUnited States
- Study dates
- 27 Aug 2004to 31 Aug 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed consent
- Hg > 11g/dl; supportive measures (erythropoietin, transfusion, iron therapy) should be utilized to assist with maintaining Hgb levels
- Total cholesterol > 160mg/dL.
- Female with primary cancer diagnosis (breast)
- Planned adjuvant chemotherapy (neoadjuvant chemotherapy is excluded)
- KPS > 60
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- Bilirubin < 1.5 x ULN
- SGOT < 2.5 x ULN
- SGPT < 2.5 x ULN
Who cannot join
- Recent involuntary weight loss (> 5% of body weight in the past 3 months)
- Statin therapy - current or planned during study. Below is a list of some commonly used statin drugs.(Note: This is a helpful guide, not a complete list.)
- Atorvastatin (Lipitor)
- Cerivastatin
- Fluvastatin (Lescol)
- Lovastatin (Mevacor, Altocor, Advicor)
Show all 18Show fewer
- Mevastatin
- Pravastatin (Pravachol)
- Rosuvastatin
- Simvastatin (Zocor)
- Current or planned use of the following medications for fatigue
- Corticosteroids (intermittent use as part of chemotherapy regimen is allowed)
- Amphetamines or other stimulants including methylphenidate (Ritalin)or modafinil (Provigil)
- Patients diagnosed with uncontrolled hypertension
- Breast cancer patients who are male
- Pregnant women are excluded from participation in this study. A Serum pregnancy test is required within 1 week of registration if the patient is a woman of childbearing potential.
- Anticoagulant therapy - current or planned during study (except for maintenance of catheter patency)
- Patients with uncontrolled thyroid dysfunction
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
Alamance Cancer Center at Alamance Regional Medical Center
Burlington, North Carolina, 27216
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403
MBCCOP - JHS Hospital of Cook County
Chicago, Illinois, 60612
CCOP - Columbus
Columbus, Ohio, 43215
Danville Regional Medical Center
Danville, Virginia, 24541
CCOP - Central Illinois
Decatur, Illinois, 62526
Southeastern Medical Oncology Center - Goldsboro
Goldsboro, North Carolina, 27534
Cancer Centers of the Carolinas - Eastside
Greenville, South Carolina, 29615
Pardee Memorial Hospital
Hendersonville, North Carolina, 28791
High Point Regional Hospital
High Point, North Carolina, 27261
South Carolina Cancer Specialists, PA at Hilton Head Medical Center
Hilton Head Island, South Carolina, 29925
Caldwell Memorial Hospital
Lenoir, North Carolina, 28645
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
Martinsville, Virginia, 24115-4788
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
Helen F. Graham Cancer Center at Christiana Hospital
Newark, Delaware, 19713
CCOP - Western Regional, Arizona
Phoenix, Arizona, 85006-2726
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65804
CCOP - Heartland Research Consortium
St Louis, Missouri, 63131
Missouri Baptist Cancer Center
St Louis, Missouri, 63131
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1030
About this study
Official title: A Randomized Double-Blind Placebo-Controlled Study Of Oral Coenzyme Q10 To Relieve Self-Reported Cancer Treatment Related Fatigue In Breast Cancer Patients
RATIONALE: Coenzyme Q10 is a vitamin that may be effective in relieving fatigue and depression in women who are undergoing chemotherapy for breast cancer.
PURPOSE: This randomized clinical trial is studying how well coenzyme Q10 works in relieving treatment-related fatigue in women with breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the effect of coenzyme Q_10 on cancer treatment-related fatigue in women with breast cancer.
Secondary
- Determine the effect of this drug on overall quality of life of these patients.
- Determine the effect of this drug on depression in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to planned radiotherapy (yes vs no) and type of chemotherapy (anthracycline vs non-anthracycline). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning on the first day of chemotherapy treatment, patients receive oral coenzyme Q_10 and oral vitamin E three times daily.
- Arm II: Beginning on the first day of chemotherapy treatment, patients receive oral vitamin E and an oral placebo three times daily.
Treatment in both arms continues for 24 weeks in the absence of unacceptable toxicity.
Quality of life, fatigue, and depression are assessed at baseline and at 8, 16, and 24 weeks.
PROJECTED ACCRUAL: A total of 101-236 patients will be accrued for this study.
- Conditions
- Breast Cancer, Fatigue
- Being tested
- CoQ10 & Vitamin E, Placebo & Vitamin E
- Keywords
- fatigue, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoQ10 & Vitamin EDietary supplement
Also called CoenzymeQ10
Placebo & Vitamin EDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - CoQ10 & Vitamin E | Active comparator | CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day. Receives: Dietary Supplement: CoQ10 & Vitamin E; Dietary Supplement: Placebo & Vitamin E |
| Arm 2 - Placebo & Vitamin E | Placebo comparator | Placebo-Vitamin E 100 mg/day in 3 doses Receives: Dietary Supplement: Placebo & Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization
POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue.
Measured: 24 weeks
Secondary outcomes (2)
Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization
FACT-B stands for Functional Assessment of Cancer Therapy - Breast. It measures quality of life. It is the total of the FACT subscales (emotional, social, functional, and physical) and the Breast subscale. Scores range from 0 to 144; higher scores reflect better overall quality of life.
Measured: 24 weeks
Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization
CES-D is the Center for Epidemiologic Studies Depression Form. It consists of 20 questions. The total score ranges from 0 to 60. Higher scores indicate greater depression.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2004 (estimated)
- Study start27 Aug 2004
- Primary completion31 Aug 2009
- Study completion31 Aug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Glenn J. Lesser, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096356
- Sponsor's protocol ID
- REBACCCWFU-97202
- Other IDs
- U10CA081851
- Acronym
- CoQ10
- Status last verified
- Sep 2021
- First submitted
- 9 Nov 2004
- Last updated
- 29 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Vitolins MZ, Case LD, Rapp SR, Lively MO, Shaw EG, Naughton MJ, Giguere J, Lesser GJ. Self-reported adherence and biomarker levels of CoQ10 and alpha-tocopherol. Patient Prefer Adherence. 2018 Apr 24;12:637-646. doi: 10.2147/PPA.S158682. eCollection 2018.
PubMed 29731611Lesser GJ, Case D, Stark N, Williford S, Giguere J, Garino LA, Naughton MJ, Vitolins MZ, Lively MO, Shaw EG; Wake Forest University Community Clinical Oncology Program Research Base. A randomized, double-blind, placebo-controlled study of oral coenzyme Q10 to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer. J Support Oncol. 2013 Mar;11(1):31-42. doi: 10.1016/j.suponc.2012.03.003.
PubMed 22682875
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Placebo-Controlled Study Of Oral Coenzyme Q10 To Relieve Self-Reported Cancer Treatment Related Fatigue In Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00096356
- Acronym / sponsor ID
- CoQ10 / REBACCCWFU-97202
- Conditions
- Breast Cancer, Fatigue
- Keywords
- fatigue, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Aug 2004 (actual)
- Primary completion
- 31 Aug 2009 (actual)
- Study completion
- 31 Aug 2009 (actual)
- First posted
- 9 Nov 2004 (estimated)
- Results
- Posted 29 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Coenzyme Q10 is a vitamin that may be effective in relieving fatigue and depression in women who are undergoing chemotherapy for breast cancer.
PURPOSE: This randomized clinical trial is studying how well coenzyme Q10 works in relieving treatment-related fatigue in women with breast cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the effect of coenzyme Q_10 on cancer treatment-related fatigue in women with breast cancer.
Secondary
- Determine the effect of this drug on overall quality of life of these patients.
- Determine the effect of this drug on depression in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to planned radiotherapy (yes vs no) and type of chemotherapy (anthracycline vs non-anthracycline). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning on the first day of chemotherapy treatment, patients receive oral coenzyme Q_10 and oral vitamin E three times daily.
- Arm II: Beginning on the first day of chemotherapy treatment, patients receive oral vitamin E and an oral placebo three times daily.
Treatment in both arms continues for 24 weeks in the absence of unacceptable toxicity.
Quality of life, fatigue, and depression are assessed at baseline and at 8, 16, and 24 weeks.
PROJECTED ACCRUAL: A total of 101-236 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - CoQ10 & Vitamin E | Active comparator | Dietary Supplement: CoQ10 & Vitamin E, Dietary Supplement: Placebo & Vitamin ECoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day. |
| Arm 2 - Placebo & Vitamin E | Placebo comparator | Dietary Supplement: Placebo & Vitamin EPlacebo-Vitamin E 100 mg/day in 3 doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed consent
- Hg > 11g/dl; supportive measures (erythropoietin, transfusion, iron therapy) should be utilized to assist with maintaining Hgb levels
- Total cholesterol > 160mg/dL.
- Female with primary cancer diagnosis (breast)
- Planned adjuvant chemotherapy (neoadjuvant chemotherapy is excluded)
Key exclusion criteria (18 listed)
- Recent involuntary weight loss (> 5% of body weight in the past 3 months)
- Statin therapy - current or planned during study. Below is a list of some commonly used statin drugs.(Note: This is a helpful guide, not a complete list.)
- Current or planned use of the following medications for fatigue
- Patients diagnosed with uncontrolled hypertension
- Breast cancer patients who are male
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoQ10 & Vitamin EAlso: CoenzymeQ10 | Dietary supplement | Arm 1 - CoQ10 & Vitamin E |
| Placebo & Vitamin E | Dietary supplement | Arm 1 - CoQ10 & Vitamin E, Arm 2 - Placebo & Vitamin E |
Primary outcome
Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization
Time frame: 24 weeks
POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue.
2 secondary outcomes
Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization
Time frame: 24 weeks
Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29731611Vitolins MZ, Case LD, Rapp SR, Lively MO, Shaw EG, Naughton MJ, Giguere J, Lesser GJ. Self-reported adherence and biomarker levels of CoQ10 and alpha-tocopherol. Patient Prefer Adherence. 2018 Apr 24;12:637-646. doi: 10.2147/PPA.S158682. eCollection 2018.
- Results publication: PubMed 22682875Lesser GJ, Case D, Stark N, Williford S, Giguere J, Garino LA, Naughton MJ, Vitolins MZ, Lively MO, Shaw EG; Wake Forest University Community Clinical Oncology Program Research Base. A randomized, double-blind, placebo-controlled study of oral coenzyme Q10 to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer. J Support Oncol. 2013 Mar;11(1):31-42. doi: 10.1016/j.suponc.2012.03.003.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn J. Lesser, MD principal investigator
Wake Forest University Health Sciences
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CoQ10 & Vitamin E in people with Breast Cancer and Fatigue, run by Wake Forest University Health Sciences at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00096356, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.