Efficacy of Zinc on Concurrent Chemo-radiotherapy Induced Taste Alterations

NCT03824925 | Completed Phase 3

• 1 other identifier: AHKhan
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Taste, Altered

Keywords

Taste alterations; zinc sulfate; oral cancer; taste acuity

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Placebo oral zinc capsules

PLACEBO COMPARATOR

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

Drug: Placebo oral Zinc capsule; Drug: Zinc Sulfate 220 MG

Zinc Sulfate 220 MG

EXPERIMENTAL

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.

Drug: Placebo oral Zinc capsule; Drug: Zinc Sulfate 220 MG

Interventions

Placebo oral Zinc capsule DRUG

Look alike cap of corn starch as a placebo of Zinc to be given on day 1 of chemo-radiotherapy

Also known as: Corn Starch

Placebo oral zinc capsules; Zinc Sulfate 220 MG

Zinc Sulfate 220 MG DRUG

Zinc sulfate in test group dose was 220 mg which is equivalent to 50 mg of elemental zinc

Also known as: Zincat

Placebo oral zinc capsules; Zinc Sulfate 220 MG

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, 76000, Pakistan

Location

MeSH Terms

Conditions

Dysgeusia; Mouth Neoplasms

Interventions

Starch; Zinc Sulfate

Condition Hierarchy (Ancestors)

Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Asma Khan, MSc-DS

  Dow Ishrat ul Ebad Institute of Oral Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Each patient was asked to pick one of the sealed envelopes from a box. The sealed envelopes contained either alphabets A or B. The sealed envelopes were blinded to both the investigator and the patient. The generation of random allocation sequence and assignment of participants to intervention were done by the principal investigator. Both the investigator and the patient were blinded (double-blinded) about the groups and intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Trainee

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 31, 2019
• Study Start: December 1, 2016
• Primary Completion: October 18, 2018
• Study Completion: November 26, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

PA (1)