- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02106806
Zinc Supplementation on Markers of Oxidative Stress in Post Operative Colorectal Cancer During Chemotherapy Cycles
April 3, 2014 updated by: Selma Freire de Carvalho da Cunha, University of Sao Paulo
Objective: To determine the oxidative stress during cycles of chemotherapy in patients after surgery for colorectal cancer, with or without oral zinc supplementation.
Subjects: Twenty four adults from both genders participated in this study.
All patients underwent stage II, III or IV colorectal cancer surgical resection and were starting chemotherapy in HCFMRP- USP.
Patients were randomized into two groups.
The first one (QTx-Zn Group, n=10) received 70 mg/d of zinc orally and the second one received placebo (QTx-Placebo Group, n=14) for 16 weeks.
The study also included 30 healthy volunteers matched for age, gender and socioeconomic status, who received 70 mg/d of zinc supplement (Control-Zn Group, n=21) or placebo (Control-Placebo Group, n=9) for 16 weeks.
Methods: The questionnaires about dietary intake (semiquantitative food frequency and food record), fatigue and quality of life (FACIT-F) and questionnaires that assess the side effects of chemotherapy (CTCAE) were evaluated.
Anthropometry and bioelectrical impedance measurements were made.
Blood collection was performed before the 1st, 2nd, 3rd and 4th cycles of chemotherapy (median duration of 21 days among cicles).
Routine laboratory tests, vitamin E and markers anti and pro-oxidants (MDA, SOD, GPx and isoprostane) ere determined.
The control group underwent the same procedures, except for chemotherapy.
A longitudinal linear mixed effects model was adjusted for each of the variables of interest.
The models were fitted using PROC MIXED of SAS version 9 (SAS, CARY, NC, USA).
To analyze the association of categorical variables in the different items of the CTCAE, the investigators used the Fisher exact test.
Results: The oral zinc supplementation was sufficient to increase plasma levels of zinc and did not alter food intake, body composition and routine laboratory evaluation of patients undergoing chemotherapy for colorectal cancer.
Compared with QTx-Placebo Group, QTx-Zn Group showed lower prevalence of complaint on the salivary gland (17 vs. 75%).
Fatigue (43 ± 6 vs. 36 ± 13) and quality of life (126 ± 160 vs. 116 ± 27) has become worst in the period between the 1st and 4th cycles of QTx in QTx-Placebo Group.
When compared with QTx-Placebo Group, QTx-Zn Group had higher values of SOD before the 1st (2297 ± 503 vs. 1604 ± 352 USOD/g Hb), 2nd (2037 ± 515 vs. 1712 ± 417 USOD/g Hb) and 4th (2202 ± 323 vs. 1821 ± 360 USOD/g Hb) cycles of QTx.
GPx values decreased in QTx-Zn Group before the 3rd cycle of QTx (48.5 ± 7.0 vs. 54.3 ± 2.3 mol NADPH/min/gHb).
Conclusions: These data suggest that zinc supplementation reduces complaints related to the change in salivary gland, preserving the quality of life and preventing the worsening of fatigue.
The increase in SOD can be attributed to zinc supplementation per se, whereas this mineral is a cofactor that endogenous antioxidant enzyme.
The highest activity of SOD increases the production of H2O2, whose detoxification involves the participation of GPx, justifying its reduction.
There were no changes in plasma levels of vitamin E, MDA and isoprostane during the study period.
Considering the values of MDA and isoprostane, the data indicate that regardless of zinc supplementation, the lipid peroxidation of the cell membrane was unchanged during chemotherapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Objective: To determine the oxidative stress during cycles of chemotherapy in patients after surgery for colorectal cancer, with or without oral zinc supplementation.
Subjects: Twenty four adults from both genders participated in this study.
All patients underwent stage II, III or IV colorectal cancer surgical resection and were starting chemotherapy in HCFMRP- USP.
Patients were randomized into two groups.
The first one (QTx-Zn Group, n=10) received 70 mg/d of zinc orally and the second one received placebo (QTx-Placebo Group, n=14) for 16 weeks.
The study also included 30 healthy volunteers matched for age, gender and socioeconomic status, who received 70 mg/d of zinc supplement (Control-Zn Group, n=21) or placebo (Control-Placebo Group, n=9) for 16 weeks.
Methods: The questionnaires about dietary intake (semiquantitative food frequency and food record), fatigue and quality of life (FACIT-F) and questionnaires that assess the side effects of chemotherapy (CTCAE) were evaluated.
Anthropometry and bioelectrical impedance measurements were made.
Blood collection was performed before the 1st, 2nd, 3rd and 4th cycles of chemotherapy (median duration of 21 days among cicles).
Routine laboratory tests, vitamin E and markers anti and pro-oxidants (MDA, SOD, GPx and isoprostane) ere determined.
The control group underwent the same procedures, except for chemotherapy.
A longitudinal linear mixed effects model was adjusted for each of the variables of interest.
The models were fitted using PROC MIXED of SAS version 9 (SAS, CARY, NC, USA).
To analyze the association of categorical variables in the different items of the CTCAE, the investigators used the Fisher exact test.
Results: The oral zinc supplementation was sufficient to increase plasma levels of zinc and did not alter food intake, body composition and routine laboratory evaluation of patients undergoing chemotherapy for colorectal cancer.
Compared with QTx-Placebo Group, QTx-Zn Group showed lower prevalence of complaint on the salivary gland (17 vs. 75%).
Fatigue (43 ± 6 vs. 36 ± 13) and quality of life (126 ± 160 vs. 116 ± 27) has become worst in the period between the 1st and 4th cycles of QTx in QTx-Placebo Group.
When compared with QTx-Placebo Group, QTx-Zn Group had higher values of SOD before the 1st (2297 ± 503 vs. 1604 ± 352 USOD/g Hb), 2nd (2037 ± 515 vs. 1712 ± 417 USOD/g Hb) and 4th (2202 ± 323 vs. 1821 ± 360 USOD/g Hb) cycles of QTx.
GPx values decreased in QTx-Zn Group before the 3rd cycle of QTx (48.5 ± 7.0 vs. 54.3 ± 2.3 mol NADPH/min/gHb).
Conclusions: These data suggest that zinc supplementation reduces complaints related to the change in salivary gland, preserving the quality of life and preventing the worsening of fatigue.
The increase in SOD can be attributed to zinc supplementation per se, whereas this mineral is a cofactor that endogenous antioxidant enzyme.
The highest activity of SOD increases the production of H2O2, whose detoxification involves the participation of GPx, justifying its reduction.
There were no changes in plasma levels of vitamin E, MDA and isoprostane during the study period.
Considering the values of MDA and isoprostane, the data indicate that regardless of zinc supplementation, the lipid peroxidation of the cell membrane was unchanged during chemotherapy.
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
Ribeirão Preto, São Paulo, Brazil, 14049-900
- Division of Medical Nutrition, Department of Internal Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- colon or rectum adenocarcinoma stages II, III, or IV
Exclusion Criteria:
- liver, kidney, or chronic inflammatory autoimmune diseases;
- active infectious diseases;
- undergoing therapy with immunosuppressant;
- use vitamin or mineral supplementation;
- had been under chemo- or radiotherapy in the previous twelve months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Zinc chemotherapy
Patients in colorectal chemotherapy supplemented with zinc
|
35 mg of elemental zinc twice daily for 16 weeks
Other Names:
|
Placebo Comparator: Placebo chemotherapy
Patients in colorectal chemotherapy with placebo
|
One capsule, twice daily for 16 weeks
Other Names:
|
Other: Zinc Control
Healthy volunteers supplemented with zinc
|
35 mg of elemental zinc twice daily for 16 weeks
Other Names:
|
Other: Placebo Control
Volunteers received placebo
|
One capsule, twice daily for 16 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
oxidative stress markers
Time Frame: 18 months
|
SOD, GPx, MDA, Isoprostane, Vitamin C, Vitamin E
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
FACIT-F
Time Frame: 18 months
|
18 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CTCAE
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sofia Miranda Ribeiro, R.D., MSc, University of Sao Paulo
- Study Director: Selma Freire Cunha, M.D., PhD, University of Sao Paulo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
March 31, 2014
First Submitted That Met QC Criteria
April 3, 2014
First Posted (Estimate)
April 8, 2014
Study Record Updates
Last Update Posted (Estimate)
April 8, 2014
Last Update Submitted That Met QC Criteria
April 3, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Dermatologic Agents
- Trace Elements
- Micronutrients
- Astringents
- Zinc
- Zinc Sulfate
Other Study ID Numbers
- FAPESP 2011/07867-4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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