Efficacy of Zinc on Concurrent Chemo-radiotherapy Induced Taste Alterations

• Status: Completed
• Trial end date: 2018-11-26
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dow University of Health Sciences
• Treatments: Zinc; Zinc Sulfate

Criteria

Inclusion Criteria:

• Oral cancer patients undergoing concurrent chemotherapy with radiotherapy for the first time as a single treatment modality.

• Patients aged between 20-60 years.

• Radiation planned between 60-70 Gy of external beam radiotherapy.

• Cisplatin as primary chemotherapeutic agent.

Exclusion Criteria:

• Previous history of radiotherapy or chemotherapy regardless of time.

• Existence of oral lesions such as aphthous ulcers, stomatitis or candidosis at the time of selection.

• Cranial nerve lesions of V, VII, IX and partial or total glossectomy.

• Individuals with nose or ear infections which can influence taste, metabolic or endocrine disorders that may affect taste sensitivity (Sjogren syndrome, hypertension, diabetes mellitus, renal disease, liver disease and thyroid disease).

• Concomitant administration of a drug with Chemoradiation which may affect taste (metronidazole, diuretics and anti-depressants).

• Individuals already on medications associated with taste disturbances such as penicillamine, tetracyclines, quinolones, and bisphosphonates for any existing condition.

• Patients who didn't agree to participate and sign consent form and lack of cooperation