FatiguePhase 2NCT02521077
Intravenous Ascorbic Acid in Women Receiving Adjuvant or Neo-Adjuvant Chemotherapy for Early Stage Breast Cancer
A Phase 2 study testing Ascorbic Acid and Normal Saline in people with Fatigue, run by Midwestern Regional Medical Center.
Trial summary
This is a parallel-track, randomized study will observe whether intravenous ascorbic acid reduces the reported fatigue in women receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fatigue
- What is being tested?
- Ascorbic Acid and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2017to Mar 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
- Diagnosed early stage breast cancer and scheduled to receive either adjuvant or neo-adjuvant chemotherapy;
- Willing to receive either intravenous ascorbic acid or normal saline;
- Willing to use an acceptable contraceptive method for the duration of the study and for 30 days following the last dose of study drug;
- Negative urine or serum pregnancy test within 2 weeks prior to receipt of study drug;
- Willing to complete all evaluation tools;
- Able to give informed consent to participate in the study; and
- Agree to avoid any additional supplemental ascorbic acid throughout the study.
Who cannot join
- Diagnosed Glucose-6-phosphate dehydrogenase deficiency;
- Renal insufficiency (Blood Urea Nitrogen >30 mg/dL, or Creatinine >1.5 mg/dL);
- Unwillingness or mental incapacity to complete self-reported questionnaires;
- Active smoker; and
- Male sex
About this study
Official title: Prospective Double Blind Study of the Effect of Intravenous High Dose Ascorbic Acid in Women Receiving Adjuvant or Neo-Adjuvant Chemotherapy for Early Stage Breast Cancer
This is a parallel-track, randomized study will observe whether intravenous ascorbic acid reduces the reported fatigue in women receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer.
- Conditions
- Fatigue
- Being tested
- Ascorbic Acid, Normal Saline
- Keywords
- Ascorbic Acid, Breast Neoplasms, Fatigue
- Medical subject headings
- Fatigue, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic AcidDrug
Also called Vitamin C
500 g ascorbic acid dissolved in 500 ml sterile water.
Normal SalineOther
Saline 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Odd Cycle Intravenous Ascorbic Acid | Experimental | Women randomized to this study arm will receive intravenous ascorbic acid (50g in 500 ml sterile water) prior to their odd-numbered chemotherapy cycles. During the even-numbered chemotherapy cycles, these subjects will receive intravenous normal saline (0.9%). Receives: Drug: Ascorbic Acid; Other: Normal Saline |
| Even Cycle Intravenous Ascorbic Acid | Experimental | Women randomized to this study arm will receive intravenous ascorbic acid (50g in 500 ml sterile water) prior to their even-numbered chemotherapy cycles. During the odd-numbered chemotherapy cycles, these subjects will receive intravenous normal saline (0.9%). Receives: Drug: Ascorbic Acid; Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue by self reported fatigue inventory questionnaire
Patients will complete the validated questionnaire Fatigue Symptom Inventory (FSI)
Measured: Day 8 of each 4-week treatment cycle.
Secondary outcomes (5)
Fatigue ( EORTC QLQ-FA13)
Patients will complete the validated questionnaire EORTC QLQ-FA13
Measured: Day 1 of each 4-week treatment cycle.
Fatigue ( EORTC QLQ-FA13)
Patients will complete the validated questionnaire EORTC QLQ-FA13
Measured: Day 8 of each 4-week treatment cycle.
Fatigue ( EORTC QLQ-FA13)
Patients will complete the validated questionnaire EORTC QLQ-FA13
Measured: Day 15 of each 4-week treatment cycle.
Fatigue by self reported fatigue inventory questionnaire
Patients will complete the validated questionnaire Fatigue Symptom Inventory (FSI)
Measured: Day 1 of each 4-week treatment cycle.
Fatigue by self reported fatigue inventory questionnaire
Patients will complete the validated questionnaire Fatigue Symptom Inventory (FSI)
Measured: Day 15 of each 4-week treatment cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startMay 2017 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Why it stopped: Manufacturer unwilling to provide information needed for IND application.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwestern Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Citrin, MD, Midwestern Regional Medical Center
- Investigators
- Dennis Citrin, MD, PhD, Principal investigator, Midwestern Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521077
- Sponsor's protocol ID
- MZ2015010
- Status last verified
- Jun 2017
- First submitted
- 27 Jul 2015
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Double Blind Study of the Effect of Intravenous High Dose Ascorbic Acid in Women Receiving Adjuvant or Neo-Adjuvant Chemotherapy for Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT02521077
- Acronym / sponsor ID
- MZ2015010
- Conditions
- Fatigue
- Keywords
- Ascorbic Acid, Breast Neoplasms, Fatigue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Manufacturer unwilling to provide information needed for IND application.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Midwestern Regional Medical CenterUniversity, hospital or other
- Study start
- May 2017 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a parallel-track, randomized study will observe whether intravenous ascorbic acid reduces the reported fatigue in women receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Odd Cycle Intravenous Ascorbic Acid | Experimental | Drug: Ascorbic Acid, Other: Normal SalineWomen randomized to this study arm will receive intravenous ascorbic acid (50g in 500 ml sterile water) prior to their odd-numbered chemotherapy cycles. During the even-numbered chemotherapy cycles, these subjects will receive intravenous normal saline (0.9%). |
| Even Cycle Intravenous Ascorbic Acid | Experimental | Drug: Ascorbic Acid, Other: Normal SalineWomen randomized to this study arm will receive intravenous ascorbic acid (50g in 500 ml sterile water) prior to their even-numbered chemotherapy cycles. During the odd-numbered chemotherapy cycles, these subjects will receive intravenous normal saline (0.9%). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
- Diagnosed early stage breast cancer and scheduled to receive either adjuvant or neo-adjuvant chemotherapy;
- Willing to receive either intravenous ascorbic acid or normal saline;
- Willing to use an acceptable contraceptive method for the duration of the study and for 30 days following the last dose of study drug;
- Negative urine or serum pregnancy test within 2 weeks prior to receipt of study drug;
Key exclusion criteria (5 listed)
- Diagnosed Glucose-6-phosphate dehydrogenase deficiency;
- Renal insufficiency (Blood Urea Nitrogen >30 mg/dL, or Creatinine >1.5 mg/dL);
- Unwillingness or mental incapacity to complete self-reported questionnaires;
- Active smoker; and
- Male sex
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 |
|---|---|---|
| Ascorbic AcidAlso: Vitamin C500 g ascorbic acid dissolved in 500 ml sterile water. | Drug | Even Cycle Intravenous Ascorbic Acid, Odd Cycle Intravenous Ascorbic Acid |
| Normal SalineSaline 0.9% | Other | Even Cycle Intravenous Ascorbic Acid, Odd Cycle Intravenous Ascorbic Acid |
Primary outcome
Fatigue by self reported fatigue inventory questionnaire
Time frame: Day 8 of each 4-week treatment cycle.
Patients will complete the validated questionnaire Fatigue Symptom Inventory (FSI)
5 secondary outcomes
Fatigue ( EORTC QLQ-FA13)
Time frame: Day 1 of each 4-week treatment cycle.
Fatigue ( EORTC QLQ-FA13)
Time frame: Day 8 of each 4-week treatment cycle.
Fatigue ( EORTC QLQ-FA13)
Time frame: Day 15 of each 4-week treatment cycle.
Fatigue by self reported fatigue inventory questionnaire
Time frame: Day 1 of each 4-week treatment cycle.
Fatigue by self reported fatigue inventory questionnaire
Time frame: Day 15 of each 4-week treatment cycle.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
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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.
Dennis Citrin, MD, PhD principal investigator
Midwestern Regional Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ascorbic Acid and Normal Saline in people with Fatigue, run by Midwestern Regional Medical Center.
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 8 inclusion and 5 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: withdrawn, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Fatigue by self reported fatigue inventory questionnaire (time frame: Day 8 of each 4-week treatment cycle.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2017.