Vit D3 and Omega 3 in Chemo Induced Neuropathy
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| ClinicalTrials.gov Identifier: NCT02294149 |
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Recruitment Status : Unknown
Verified April 2015 by Nathaniel Bouganim, McGill University Health Center.
Recruitment status was: Recruiting
First Posted : November 19, 2014
Last Update Posted : April 7, 2015
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Sponsor:
McGill University Health Center
Information provided by (Responsible Party):
Nathaniel Bouganim, McGill University Health Center
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Brief Summary:
The purpose of this study is to determine whether administration of mammalian Omega 3 FA(fatty acid) with Vitamin D3 supplements would lower or prevent the risk of neuropathy due to chemotherapy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer Neuropathy | Drug: mammalian Omega 3 Fatty acids Drug: placebo | Phase 3 |
The primary objective of this study is to evaluate the impact of mammalian oil Omega 3 FA with Vitamin D3 supplementation on resolution or prevention of Taxanes or Platinum induced peripheral neuropathy compared with placebo. Patients will be allocated to receive the Omega 3 FA & Vitamin D3 supplements or placebo for 6 months. Approximately 600 patients in total will be enrolled in the 2 study arms. The evaluation of neuropathy will be accomplished by electromyography (EMG), Total neuropathy score(TNS), Brief pain inventory (BFI) and the 11-item FACT/GOG-Ntx, version 4 questionnaire (a subscale validated to assess neuropathy due to chemotherapy). In addition, other validated functional measures such as "Time to button a six hole shirt" and "50 ft walk speed test" will be used to test patients physical limitations imposed by peripheral neuropathy. All our patients will undergo an EMG at their first visit, in 3 months and after 6months. Previously mentioned functional measures will also be completed at the patients' first visit, in 3 months and after 6 months.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 600 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | A Randomized Controlled Trial of Mammalian Omega 3 With Vitamin D3 in Patients at Risk of Chemotherapy Induced Peripheral Neuropathy. |
| Study Start Date : | January 2015 |
| Actual Primary Completion Date : | April 2015 |
| Estimated Study Completion Date : | November 2016 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
A ineffective placebo drug with the same taste, route of administration and physical appearance as the study drug (omega 3/Vit D 3) that has received approval by health Canada.
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Drug: placebo |
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Experimental: Omega 3 FA/Vitamin D3 sublingual
patients will be allocated randomly to receive Sub-lingual Omega 3 FA and Vitamin D3 supplements for 6 months, twice daily ,1/2 tea spoon with instructions to keep it under the tongue for 45 sec.
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Drug: mammalian Omega 3 Fatty acids
A mammalian oil derived Omega 3 FA that is a further concentrated and purified supplement as compared to the regular fish oil derived Omega 3 FA supplement. |
Primary Outcome Measures :
- percentage of participants with a 50% decreases in Total neuropathy score [ Time Frame: 3 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Will be receiving chemotherapy(Platinums and/or Taxanes) in the following 2 weeks.
- Histologically confirmed diagnosis of cancer
- ECOG 0 to 2
Exclusion Criteria:
- Prior chemotherapy treatment
- Pre-existing peripheral PN due to DM,HIV, alcohol abuse, thyroid dysfunction and hereditary PN associated disorders.
- Taking any nutritional supplement( fish oil, vitamins and minerals) at least there months before enrollment.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294149
Contacts
| Contact: Ralph Maroun, MD | 5147080701 | ralph-maroun@hotmail.com | |
| Contact: Nathaniel Bouganim, MD | 514-934-1934 ext 34970 | nathaniel.bouganim@mail.mcgill.ca |
Locations
| Canada, Quebec | |
| McGill university health center, Royal Victoria hospital | Recruiting |
| Montreal, Quebec, Canada, h3a 1a1 | |
| Contact: Nathaniel Bouganim, MD 514-934-1934 ext 34970 nathaniel.bouganim@mail.mcgill.ca | |
Sponsors and Collaborators
McGill University Health Center
| Responsible Party: | Nathaniel Bouganim, Dr. Nathaniel Bouganim, Medical Oncologist at Royal Victoria Hospital muhc, McGill University Health Center |
| ClinicalTrials.gov Identifier: | NCT02294149 History of Changes |
| Other Study ID Numbers: |
4086 |
| First Posted: | November 19, 2014 Key Record Dates |
| Last Update Posted: | April 7, 2015 |
| Last Verified: | April 2015 |
Keywords provided by Nathaniel Bouganim, McGill University Health Center:
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chemotherapy Omega 3 |
Additional relevant MeSH terms:
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Vitamins Vitamin D Cholecalciferol Micronutrients |
Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |