Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCIC-4738 | Other Grant/Funding Number | National Cancer Institute of Canada | |
| NCIC-8176 | Other Grant/Funding Number | National Cancer Institute of Canada | |
| NCIC-13211 | Other Grant/Funding Number | National Cancer Institute of Canada | |
| NCIC-019502 | Other Grant/Funding Number | National Cancer Institute of Canada | |
| 1R03CA141615-01 | U.S. NIH Grant/Contract | View source | |
| 018100 | Other Grant/Funding Number | National Cancer Institute of Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Canadian Cancer Trials Group | NETWORK |
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Epidemiologic studies suggest that low dietary intakes and low plasma concentrations of antioxidant vitamins and minerals are associated with increased risks of cancer, especially for epidermoid tumors. Patients with stage I or II head and neck cancer have a good prognosis, with a 5-year relative survival of 60% to 90%, depending of the tumor site. However, the benefit of treatment is often compromised by the occurrence of second primary cancers, which develop in 20% of patients during the first 5 years after diagnosis. We conducted a randomized chemoprevention trial among patients with head and neck cancer treated by radiation therapy to determine whether supplementation combining two antioxidants, alpha-tocopherol and beta-carotene, could reduce the incidence of second primary cancers in this patient population (primary objective of the trial). This study was conducted with funds from the NCIC (#008176,004738,013211) and was completed.
In this cohort of head and neck cancer patients, we evaluated whether nine potential prognostic serum markers measured at the time of diagnosis were related to recurrence, occurence of second primary cancers and survival. This study was conducted with funds from the NCIC (#018100) and was completed.
Presently, we evaluate genetic polymorphisms(GWAS) associated with prognosis (NCIC grant #019502). We also assess the relationship between vitamin D (dietary intake, serum level, and genetic polymorphisms of key vitamin D-related genes) and head and neck long-term outcomes (NCI grant #1R03CA141615-01).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alpha-Tocopherol and Beta-Carotene | Experimental | Patients received a daily supplementation of alpha-tocopherol (one capsule of 400 IU dl-alpha-tocopherol) and beta-carotene (one capsule of 30 mg) for 3 years after the end of radiation therapy. Due to ethical concerns, the beta-carotene supplementation was stopped during the trial (after the randomization of 156 patients). See details in JNCI, 2005: 97 (7), 481-8. |
|
| Placebo | Placebo Comparator | Patients received two capsules of placebos per day during 3 years. When the beta-carotene was stopped, they received only one capsule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha-Tocopherol and Beta-Carotene | Dietary Supplement | Provided by Roche Vitamins Inc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Second primary cancers | Immediately and 1 month after radiation therapy, every 6 months during the 3 years following the end of radiation therapy, and then once a year until June 30, 2003 |
| Measure | Description | Time Frame |
|---|---|---|
| Acute and late side-effects of radiation therapy | During radiation therapy (RT), at the end of RT, one month after RT, six months after RT and 1 year after RT | |
| Quality of life | Baseline, at the end of radiation therapy (RT), 1, 6,12,24 and 36 months after RT |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Isabelle Bairati, MD, PhD | Laval University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laval University Cancer Research Center | Québec | Quebec | G1R 2J6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16027437 | Result | Bairati I, Meyer F, Gelinas M, Fortin A, Nabid A, Brochet F, Mercier JP, Tetu B, Harel F, Abdous B, Vigneault E, Vass S, Del Vecchio P, Roy J. Randomized trial of antioxidant vitamins to prevent acute adverse effects of radiation therapy in head and neck cancer patients. J Clin Oncol. 2005 Aug 20;23(24):5805-13. doi: 10.1200/JCO.2005.05.514. Epub 2005 Jul 18. | |
| 15812073 | Result | Bairati I, Meyer F, Gelinas M, Fortin A, Nabid A, Brochet F, Mercier JP, Tetu B, Harel F, Masse B, Vigneault E, Vass S, del Vecchio P, Roy J. A randomized trial of antioxidant vitamins to prevent second primary cancers in head and neck cancer patients. J Natl Cancer Inst. 2005 Apr 6;97(7):481-8. doi: 10.1093/jnci/dji095. |
Not provided
Not provided
A letter was sent to each participant.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D016609 | Neoplasms, Second Primary |
| D006258 | Head and Neck Neoplasms |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D024502 | alpha-Tocopherol |
| D019207 | beta Carotene |
| ID | Term |
|---|---|
| D024505 | Tocopherols |
| D014810 | Vitamin E |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Dietary Supplement | Provided by Roche Vitamins Inc |
|
| Recurrence | Immediately and 1 month after radiation therapy, every 6 months during the 3 years following the end of radiation therapy, and then once a year until June 30, 2003 |
| Cancer free survival | Without recurrence and without second primary cancer | Immediately and 1 month after radiation therapy, every 6 months during the 3 years following the end of radiation therapy, and then once a year until June 30, 2003 |
| Overall survival | Every year |
| Disease free survival | Alive and without recurrence | Immediately and 1 month after radiation therapy, every 6 months during the 3 years following the end of radiation therapy, and then once a year until June 30, 2003 |
| Survival until death from first cancer | every year |
| Survival until death from second primary cancer | Every year |
| Survival until death from non-cancer causes | Every year |
| 16841333 | Result | Bairati I, Meyer F, Jobin E, Gelinas M, Fortin A, Nabid A, Brochet F, Tetu B. Antioxidant vitamins supplementation and mortality: a randomized trial in head and neck cancer patients. Int J Cancer. 2006 Nov 1;119(9):2221-4. doi: 10.1002/ijc.22042. |
| 17927499 | Result | Meyer F, Bairati I, Jobin E, Gelinas M, Fortin A, Nabid A, Tetu B. Acute adverse effects of radiation therapy and local recurrence in relation to dietary and plasma beta carotene and alpha tocopherol in head and neck cancer patients. Nutr Cancer. 2007;59(1):29-35. doi: 10.1080/01635580701397590. |
| 18172254 | Result | Sackett MK, Bairati I, Meyer F, Jobin E, Lussier S, Fortin A, Gelinas M, Nabid A, Brochet F, Tetu B. Prognostic significance of cyclooxygenase-2 overexpression in glottic cancer. Clin Cancer Res. 2008 Jan 1;14(1):67-73. doi: 10.1158/1078-0432.CCR-07-2028. |
| 19451440 | Result | Meyer F, Fortin A, Gelinas M, Nabid A, Brochet F, Tetu B, Bairati I. Health-related quality of life as a survival predictor for patients with localized head and neck cancer treated with radiation therapy. J Clin Oncol. 2009 Jun 20;27(18):2970-6. doi: 10.1200/JCO.2008.20.0295. Epub 2009 May 18. |
| 20103685 | Result | Meyer F, Samson E, Douville P, Duchesne T, Liu G, Bairati I. Serum prognostic markers in head and neck cancer. Clin Cancer Res. 2010 Feb 1;16(3):1008-15. doi: 10.1158/1078-0432.CCR-09-2014. Epub 2010 Jan 26. |
| 20187097 | Result | Nourissat A, Bairati I, Samson E, Fortin A, Gelinas M, Nabid A, Brochet F, Tetu B, Meyer F. Predictors of weight loss during radiotherapy in patients with stage I or II head and neck cancer. Cancer. 2010 May 1;116(9):2275-83. doi: 10.1002/cncr.25041. |
| 20533282 | Result | Meyer F, Liu G, Douville P, Samson E, Xu W, Adjei A, Bairati I. Dietary vitamin D intake and serum 25-hydroxyvitamin D level in relation to disease outcomes in head and neck cancer patients. Int J Cancer. 2011 Apr 1;128(7):1741-6. doi: 10.1002/ijc.25496. Epub 2010 Jun 7. |
| 18059031 | Result | Meyer F, Bairati I, Fortin A, Gelinas M, Nabid A, Brochet F, Tetu B. Interaction between antioxidant vitamin supplementation and cigarette smoking during radiation therapy in relation to long-term effects on recurrence and mortality: a randomized trial among head and neck cancer patients. Int J Cancer. 2008 Apr 1;122(7):1679-83. doi: 10.1002/ijc.23200. |
| 21424341 | Result | Nourissat A, Bairati I, Fortin A, Gelinas M, Nabid A, Brochet F, Tetu B, Meyer F. Factors associated with weight loss during radiotherapy in patients with stage I or II head and neck cancer. Support Care Cancer. 2012 Mar;20(3):591-9. doi: 10.1007/s00520-011-1132-x. Epub 2011 Mar 20. |
| 21640495 | Result | Meyer F, Fortin A, Wang CS, Liu G, Bairati I. Predictors of severe acute and late toxicities in patients with localized head-and-neck cancer treated with radiation therapy. Int J Radiat Oncol Biol Phys. 2012 Mar 15;82(4):1454-62. doi: 10.1016/j.ijrobp.2011.04.022. Epub 2011 Jun 2. |
| 22009713 | Result | Azad AK, Bairati I, Samson E, Cheng D, Cheng L, Mirshams M, Savas S, Waldron J, Wang C, Goldstein D, Xu W, Meyer F, Liu G. Genetic sequence variants and the development of secondary primary cancers in patients with head and neck cancers. Cancer. 2012 Mar 15;118(6):1554-65. doi: 10.1002/cncr.26446. Epub 2011 Aug 25. |
| 22076708 | Result | Azad AK, Bairati I, Samson E, Cheng D, Mirshams M, Qiu X, Savas S, Waldron J, Wang C, Goldstein D, Xu W, Meyer F, Liu G. Validation of genetic sequence variants as prognostic factors in early-stage head and neck squamous cell cancer survival. Clin Cancer Res. 2012 Jan 1;18(1):196-206. doi: 10.1158/1078-0432.CCR-11-1759. Epub 2011 Nov 10. |
| 23169318 | Result | Azad AK, Bairati I, Qiu X, Huang H, Cheng D, Liu G, Meyer F, Adjei A, Xu W. Genetic sequence variants in vitamin D metabolism pathway genes, serum vitamin D level and outcome in head and neck cancer patients. Int J Cancer. 2013 Jun 1;132(11):2520-7. doi: 10.1002/ijc.27946. Epub 2012 Dec 14. |
| 27173062 | Result | Azad AK, Bairati I, Qiu X, Girgis H, Cheng L, Waggott D, Cheng D, Mirshams M, Ho J, Fortin A, Vigneault E, Huang SH, O'Sullivan B, Waldron J, Boutros PC, Goldstein D, Meyer F, Xu W, Liu G. A genome-wide association study of non-HPV-related head and neck squamous cell carcinoma identifies prognostic genetic sequence variants in the MAP-kinase and hormone pathways. Cancer Epidemiol. 2016 Jun;42:173-80. doi: 10.1016/j.canep.2016.05.001. Epub 2016 May 9. |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |