Peripheral Neuropathy in Breast Cancer PatientPhase 2CIPNNCT02795572
Nutraceuticals Versus Usual Care in the Prevention or Reduction of CIPN in Patients Treated With Docetaxel as Neoadjuvant/Adjuvant Breast Cancer Therapy
A Phase 2 study testing Vitamin D, Vitamin B6 and Vitamin B12 in people with Peripheral Neuropathy in Breast Cancer Patient, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
The trial will utilize Nutraceuticals (Vitamin D 2000IU oral once daily, Vitamin B6 100 mg oral once daily, Vitamin B12 100 mcg oral once daily, Omega-3 Fatty Acids 900 mg oral three times a day) in patients treated with Docetacel as Neoadjuvant or Adjuvant Breast cancer Therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Peripheral Neuropathy in Breast Cancer Patient
- What is being tested?
- Vitamin D, Vitamin B6 and Vitamin B12
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jun 2017to 31 Aug 2017
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female 18-70 years of age
- Biopsy proven invasive breast carcinoma
- Scheduled to receive docetaxel (3-6 cycles)
- Have values for liver (AST, ALT, Bilirubin) and renal function (CREAT), within 1.5 times normal values as drawn per standard of care.
- ECOG 0-2
- Be able to provide informed consent
- Willingness to adhere to regimen
Who cannot join
- Metastatic disease
- Any peripheral neuropathy
- Known HIV (testing not required)
- Diseases causing malabsorption i.e.: Inflammatory Bowel Disease, Celiac and Whipple's Disease
- Patients with seafood allergies
- Patients on Warfarin or with a documented clinically significant bleeding disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocol Comparing a Nutraceutical Formulation Consisting of Omega-3 Fatty Acids, Vitamin D, and Vitamins B6 Plus B12 Versus No Treatment in the Prevention or Reduction of Chemotherapy Induced Peripheral Neuropathy (CIPN) in Patients Treated With Docetaxel as Neoadjuvant/Adjuvant Breast Cancer Therapy
The trial will utilize Nutraceuticals (Vitamin D 2000IU oral once daily, Vitamin B6 100 mg oral once daily, Vitamin B12 100 mcg oral once daily, Omega-3 Fatty Acids 900 mg oral three times a day) in patients treated with Docetacel as Neoadjuvant or Adjuvant Breast cancer Therapy. The trial is being conducted to see if the use of Nutraceuticals will prevent or reduce Chemotherapy Induced Peripheral Neuropathy (CIPN).
Read the detailed description
Phase 2, Single Centre, Open-label 2 Arm Randomized Trial. The intervention group will receive a daily dose of Vitamin D, Omega-3-fatty acids, Vitamin B6, and Vitamin B12. The reference group will have usual care.
Dose of Nutraceuticals: Vitamin D 2000 IU oral once daily, Vitamin B6 100 mg oral once daily, Vitamin B12 100 mcg oral once daily, Omega-3 Fatty Acids 900 mg oral three times a day (600 mg EPA, 300 mg DHA)
Population: Breast Cancer patients undergoing either neoadjuvant or adjuvant therapy with docetaxel.
106 participants in total will be needed with accrual being completed in hopefully 1 years' time. Study Investigators will screen the candidates for the study.
- Being tested
- Vitamin D, Vitamin B6, Vitamin B12, Omega-3 Fatty Acids
- Keywords
- Breast Neoplasms, Peripheral Neuropathies
- Medical subject headings
- Breast Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Vitamin D 2000 IU oral once daily
Vitamin B6Dietary supplement
Vitamin B6 100 mg oral once daily
Vitamin B12Dietary supplement
Vitamin B12 100 mcg oral once daily
Omega-3 Fatty AcidsDietary supplement
Omega-3 Fatty Acids 900 mg oral three times a day (600 mg EPA, 300 mg DHA)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will receive a daily dose of Vitamin D 2000 IU, Vitamin B6 100 mg, Vitamin B12 100 mcg and Omega-3 Fatty Acids 2700 mg [900 mg TID (600 mg EPA, 300 mg DHA)]. Receives: Dietary Supplement: Vitamin D; Dietary Supplement: Vitamin B6; Dietary Supplement: Vitamin B12; Dietary Supplement: Omega-3 Fatty Acids |
| Reference Group | No intervention | Reference group will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy Induced Peripheral Neuropathy Assessment
To determine if there is a reduction in either severity or incidence of CIPN in patients treated with docetaxel in the female breast cancer population by using a nutraceutical formulation of the investigators design.
Measured: 12 months
Secondary outcomes (2)
Delay in the onset of grade 1 or decrease in the severity of CIPN
Measured: 12 months after initiation of chemotherapy
Affect of Usage of Nutraceuticals on Response to treatment
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study start27 Jun 2017
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Why it stopped: Retirement of the Principal Investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Neuropathy in Breast Cancer PatientStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katia Tonkin, MD, Principal investigator, AHS Cancer Control Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795572
- Sponsor's protocol ID
- CIPNN-SMG-CCI-01
- Acronym
- CIPN
- Status last verified
- Jul 2019
- First submitted
- 30 May 2016
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol Comparing a Nutraceutical Formulation Consisting of Omega-3 Fatty Acids, Vitamin D, and Vitamins B6 Plus B12 Versus No Treatment in the Prevention or Reduction of Chemotherapy Induced Peripheral Neuropathy (CIPN) in Patients Treated With Docetaxel as Neoadjuvant/Adjuvant Breast Cancer Therapy
- ClinicalTrials.gov ID
- NCT02795572
- Acronym / sponsor ID
- CIPN / CIPNN-SMG-CCI-01
- Keywords
- Breast Neoplasms, Peripheral Neuropathies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Retirement of the Principal Investigator
- Enrolment
- 13 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 10 Jun 2016 (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.
The trial will utilize Nutraceuticals (Vitamin D 2000IU oral once daily, Vitamin B6 100 mg oral once daily, Vitamin B12 100 mcg oral once daily, Omega-3 Fatty Acids 900 mg oral three times a day) in patients treated with Docetacel as Neoadjuvant or Adjuvant Breast cancer Therapy. The trial is being conducted to see if the use of Nutraceuticals will prevent or reduce Chemotherapy Induced Peripheral Neuropathy (CIPN).
Detailed description
Phase 2, Single Centre, Open-label 2 Arm Randomized Trial. The intervention group will receive a daily dose of Vitamin D, Omega-3-fatty acids, Vitamin B6, and Vitamin B12. The reference group will have usual care.
Dose of Nutraceuticals: Vitamin D 2000 IU oral once daily, Vitamin B6 100 mg oral once daily, Vitamin B12 100 mcg oral once daily, Omega-3 Fatty Acids 900 mg oral three times a day (600 mg EPA, 300 mg DHA)
Population: Breast Cancer patients undergoing either neoadjuvant or adjuvant therapy with docetaxel.
106 participants in total will be needed with accrual being completed in hopefully 1 years' time. Study Investigators will screen the candidates for the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Vitamin D, Dietary Supplement: Vitamin B6, Dietary Supplement: Vitamin B12, Dietary Supplement: Omega-3 Fatty AcidsThe intervention group will receive a daily dose of Vitamin D 2000 IU, Vitamin B6 100 mg, Vitamin B12 100 mcg and Omega-3 Fatty Acids 2700 mg [900 mg TID (600 mg EPA, 300 mg DHA)]. |
| Reference Group | No intervention | –Reference group will receive usual care. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female 18-70 years of age
- Biopsy proven invasive breast carcinoma
- Scheduled to receive docetaxel (3-6 cycles)
- Have values for liver (AST, ALT, Bilirubin) and renal function (CREAT), within 1.5 times normal values as drawn per standard of care.
- ECOG 0-2
Key exclusion criteria (6 listed)
- Metastatic disease
- Any peripheral neuropathy
- Known HIV (testing not required)
- Diseases causing malabsorption i.e.: Inflammatory Bowel Disease, Celiac and Whipple's Disease
- Patients with seafood allergies
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 |
|---|---|---|
| Vitamin DVitamin D 2000 IU oral once daily | Dietary supplement | Intervention Group |
| Vitamin B6Vitamin B6 100 mg oral once daily | Dietary supplement | Intervention Group |
| Vitamin B12Vitamin B12 100 mcg oral once daily | Dietary supplement | Intervention Group |
| Omega-3 Fatty AcidsOmega-3 Fatty Acids 900 mg oral three times a day (600 mg EPA, 300 mg DHA) | Dietary supplement | Intervention Group |
Primary outcome
Chemotherapy Induced Peripheral Neuropathy Assessment
Time frame: 12 months
To determine if there is a reduction in either severity or incidence of CIPN in patients treated with docetaxel in the female breast cancer population by using a nutraceutical formulation of the investigators design.
2 secondary outcomes
Delay in the onset of grade 1 or decrease in the severity of CIPN
Time frame: 12 months after initiation of chemotherapy
Affect of Usage of Nutraceuticals on Response to treatment
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Retirement of the Principal Investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Peripheral Neuropathy in Breast Cancer Patient
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Not yet recruitingPhase 2
Evaluation of the Effect of Amantadine in the Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients
Breast Cancer, Peripheral Neuropathy Due to Chemotherapy
Active, not recruitingPhase 2
Agnostic Therapy in Rare Solid Tumors
Urachal Cancer, Parathyroid Carcinoma
Active, not recruitingPhase 2
Docetaxel or Paclitaxel in Reducing Chemotherapy-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Active, not recruitingObservational study
Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
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.
Katia Tonkin, MD principal investigator
AHS Cancer Control Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D, Vitamin B6 and Vitamin B12 in people with Peripheral Neuropathy in Breast Cancer Patient, run by AHS Cancer Control Alberta at 1 site in Canada.
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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. 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 stopped early (reason given: Retirement of the Principal Investigator). Results are not available in the source record.
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?
Chemotherapy Induced Peripheral Neuropathy Assessment (time frame: 12 months). 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 5 Jul 2019.