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Efficacy of Zinc Sulfate on Concurrent Chemoradiotherapy Induced Taste Alterations in Oral Cancer Patients- A Double Blind Randomized Controlled Trial
Sponsor study identifier
interventional
70
1 country
1
Study Start
December 1, 2016
Actual (reported)Primary Completion
October 18, 2018
Actual (reported)Study Completion
November 26, 2018
Actual (reported)Taste changes are common in cancer patients receiving concurrent chemoradiation which become a significant complaint and a cause of distress and morbidity. Loss of gustatory function further advances to malnutrition, weight loss, reduced quality of life, poor compliance and even diminished response to drug therapy. Taste is an essential sensation which serves oral intake of food and enables to prevent the ingestion of potentially harmful and poisonous substances. The sense of taste is crucial for an individual's well-being and psychological health. Taste changes may advance to reduced appetite, dietary insufficiency, food repulsion affecting body weight and anorexia further leading to impaired immunity, decline in health status and malnutrition. As taste impairment is not a life-threatening event therefore it might not be reported by some patients. Hence, this aspect is neglected despite being a common and distressing side-effect of chemoradiation. Due to the location of the cancer and the long-term effects of cancer therapies, patients with oral cavity cancers have a specially high prevalence of chemosensory disorders. Zinc is comparatively non-toxic if taken orally, and rather non-toxic in contrast to other trace metals such as manganese and iron. Zinc is an integral element in both the maintenance and repair of taste buds. It is involved in promoting the diffusion of taste stimuli to taste buds. Salivary zinc has been found in association with Gustin (carbonic anhydrase, CA VI), a zinc-metalloprotein enzyme that may be involved with providing nutrition to the human taste buds. Zinc influences the synthesis of gustin required for the growth, development, maintenance and production of taste buds and regulation of taste function. The hypothesis was: Null hypotheses: There is no difference in the taste acuity between test and control group with the administration of zinc sulfate. Alternative hypotheses: There is a difference in the taste acuity between test and control group with the administration of zinc sulfate. Thus, the present study aimed to observe changes in taste function of oral cancer patients by detection and recognition thresholds before beginning their treatment (before chemoradiation and intervention), at the end of chemoradiation and a month after and to evaluate the preventive effect of zinc sulfate on chemoradiation-induced taste changes. To the best of our knowledge, similar study has not been conducted before in our region.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 26, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 1, 2016
Actual (reported)October 18, 2018
Actual (reported)November 26, 2018
Actual (reported)January 23, 2019
Actual (reported)January 31, 2019
Actual (reported)Change in taste acuity with the administration of zinc sulfate in oral cancer patients receiving chemo-radiotherapy by detection and recognition threshold on a proforma
Every participant's taste acuity was by detection and recognition using different concentrations of taste solutions. The solutions were prepared in accordance with the International Standard Organization 3972:2011/Cor 1:2012 which provides guidelines for Method of investigating of taste sensitivity. Sodium chloride was used as a stimulus for salty, sucrose for sweet, citric acid for sour and caffeine for bitter. Detection threshold was the minimum concentration at which the subject can detect that there is something different from water, but may not identify its quality. Recognition threshold was considered as the lowest level of a solution at which a subject can correctly recognize its taste.
Taste acuity was observed for each taste at 3 stages that is, Baseline: before starting chemo-radiotherapy, after 7-8 week (on last day of chemo-radiotherapy), 11-12 week (follow-up after 1 month of their therapy)
Group A: It was the control group. Participants were advised to start taking placebo capsule of Zinc in a look alike preparation on their first day of chemo-radiotherapy and continued taking it a month after their chemo-radiotherapy ended
Group B: Cap zinc 220 mg (equivalent to 50 mg of elemental zinc) on 1st day of their chemo-radiotherapy and continued taking it a month after their chemo-radiotherapy ended.
Look alike cap of corn starch as a placebo of Zinc to be given on day 1 of chemo-radiotherapy
Zinc sulfate in test group dose was 220 mg which is equivalent to 50 mg of elemental zinc
Dow University of Health Sciences
Karachi, Sindh, 76000, Pakistan
Asma Khan, MSc-DS
Dow Ishrat ul Ebad Institute of Oral Health Sciences
70 participants (actual enrollment reported by the registry).
First Submitted
January 23, 2019
First Posted
January 31, 2019
Contact the study team to confirm eligibility.
Study Start
December 1, 2016
Actual (reported)Primary Completion
October 18, 2018
Actual (reported)Study Completion
November 26, 2018
Actual (reported)Last Updated
January 31, 2019
Record last verified: 2019-01
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