Infections

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Warts

Communicable Diseases

Papillomavirus Infections

Virus Diseases

DNA Virus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

Hypoglycemic Agents

All Drugs and Chemicals

Dermatologic Agents

Pharmaceutical Solutions

Micronutrients

Insulin

Insulin, Globin Zinc

Zinc Sulfate

Zinc

Astringents

The first group will receive Intralesional injection of Candidal antigen with a dose of (0.1ml -0.3ml) by insulin syringe in the largest wart at the first visit.( Only those patients who showed a positive response to the Candida test antigen).I njections will be repeated for all patients into the same lesion every 3 weeks for three treatment sessions. Follow up for next six months for any recurrences.

Storage: A 1ml multidose vial of candidal antigen (Candin) which is an intradermal test antigen, stored between 2c-8c.

The second group will receive an IL injection of 2%Zn sulfate with a dose of (0.1ml-0.3ml) by insulin syringe ,in the largest one .the wart is injected with the solution till blanching or bleb formation. Subcutaneous injections and acral parts such as fingers and toes will be avoided, as it may cause vascular necrosis \[19\]. Injections will be repeated for all patients into the same lesion every 2 weeks for three treatment sessions.Follow up for next six months for any recurrences.

Preparation of 2% zinc sulfate: A measure of 2g. of zinc sulfate powder is to be dissolved in 100 ml of sterile distilled water and autoclaved at 95c for 20 min(20).

Candida Antigen

Eman Mohamed Kamal, MD

Radwa Bakr, MD

Eman Kamal, MD

Warts are common and infectious viral diseases of the skin and are prevalent worldwide. Warts are caused by the human papilloma virus (HPV), which has more than 100 strains; some of them are known to be premalignant .Although warts can appear at any age, they are more common in children and adolescents. The prognosis of warts cannot be predicted. In some patients they may spontaneously disappear, whereas others show persistence and progression with spreading to other body sites, leading to physical and emotional distress to the patients. \[ 1 \].

Forty percent of children spontaneously clear in two years without treatment owing to natural immunity \[ 2,3.\]. However, warts can persist and increase in size and number \[2\] .

Warts may reflect a localized or systemic cell-mediated immune (CMI) deficiency to HPV. Various reasons like lack of production of memory T cells to target HPV infection, failure of clonal expansion of lymphocytes to adequate stimulation, inability of T lymphocytes to traffic to sites of infection and weak effector response mechanism have been hypothesized. \[4\] .\] Consequently, warts are particularly exuberant in patients with Hodgkin's disease, AIDS and those on immunosuppressant \[ 5 \].

The conventional modalities in treatment of warts include destructive therapies such as salicylic acid, trichloroacetic acid, cryotherapy, silver nitrate, phenol, canthiridin, electrocautary, surgical interventions and lasers; antiproliferative agents such as bleomycin, vitamin D analogs, podophyllin, and 5-fluro uracil; antiviral agents such as cidofovir and retinoids. Because of the cumbersome nature of these procedures and a high risk of recurrence, immunotherapy is becoming more and more popular, especially in the treatment of refractory cutaneous and genital warts \[ 6 \] . It enhances recognition of the virus by the immune system. This allows not only clearing of the treated wart, and frequently warts at distant anatomic sites, but also may prevent future clinical infection \[ 7 \] .

Immunotherapy in warts can be administered by various methods. The first method is topical application of certain inorganic molecules that are capable of eliciting a contact hypersensitivity reaction with secondary activation of an immunological response \[ 8 \] . A second modality is the use of oral immune modulators such as cimetidine and zinc(10mg/kg/day for 2months) \[ 9 , 10 \] .

A third method is Intralesional injection of immunotherapeutic agent that utilizes the ability of the immune system to mount a delayed type hypersensitivity response to various antigens and also the wart tissue leading to production of Th1 cytokines which activate cytotoxic and natural killer cells to eradicate HPV infection. This clears not only the local warts but also distant warts unlike traditional wart therapies \[ 11 \] .

There are a few side effects reported by most of the studies. The most common side effect was pain and discomfort during injection, however, serious side effects such as vitiligo-like depigmentation and painful purple digit have also been reported \[ 12 \] .

Zinc is important for immune regulation as it stimulates the leucocytes and natural killer cells. It has been shown that there is a deficiency of zinc in patients with multiple or recurrent warts \[ 13 ,14 \].The use of zinc in treatment of warts was proven in many studies either in the topical form or systemic oral therapy \[ 15 \].. However, Little studies have utilized intralesional injection of 2% zinc sulfate solution for the treatment of common wart one of them was of \[16\] .

Intralesional Candidal Antigen Versus Intralesional Zinc Sulphate in Treatment of Cutaneous Warts

Intralesional Candidal Antigen Versus Intralesional Zinc Sulphate in Treatment of Cutaneous Warts, A Randomized Clinical Trial

Assiut University

principle investigator

Neoplasms

Mouth and Tooth Diseases

Nervous System Diseases

Rare Diseases

Mouth Neoplasms

Dysgeusia

Taste Disorders

Sensation Disorders

Neurologic Manifestations

Oral Cancer

Lip and Oral Cavity Cancer

Trace Elements

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

Placebo oral Zinc capsule

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

Zinc Sulfate 220 MG

Asma Khan, MSc-DS

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.

Consecutive Sampling was used. It was a two-stage sampling method. Data was collected from patients visiting the Oncology Section at Atomic Energy Medical Centre Karachi from September 2017 to March 2018 on a proforma after being examined by the section head oncologist for the tumor. A standard proforma was used to record the taste acuity of the participants. Furthermore, the proforma also had details about patient's site of tumor, stage of tumor, daily fraction of dose, total dose of radiotherapy, chemotherapeutic drug and duration of the treatment for the record.

The international Standard Organization ISO 3972:2011/Cor 1:2012 provides guidelines for Method of investigating sensitivity of taste. Therefore, all solutions were prepared in accordance with the ISO. The solutions were prepared with deionized water in grams/litre and stored in 1000ml glass bottles at room temperature. All solutions were colorless and odorless. Eight increasing concentration of each taste (salty, sweet, sour and bitter; altogether 32 bottles), zinc capsules and placebo (filled with cornstarch) were prepared by ATCO pharmaceuticals. Sodium chloride was used as a stimulus for salty, sucrose for sweet, citric acid for sour and caffeine for bitter.

Patients were instructed to refrain from eating or drinking 30 mins to 1 hour before the procedure. If any patient was wearing denture it was taken off before the procedure and mouth was thoroughly rinsed with water before each trial. Each subject was given single 15ml of each solution in a cup and asked to hold the solution for 30 seconds in their mouth and gargle out to make sure the whole of oral cavity will be exposed to the taste solution (sip and spit procedure). After each presentation, patient mouth was thoroughly rinsed with water to remove any after taste and to avoid the residual effect of the previous taste solution. The water used for rinsing was identical with that used for preparing solutions. Each trial was spaced at least 15 seconds apart. The time spent for each data collection tool was 20-30 mins.

Taste function of each patient for four basic taste (salty, sweet, sour and bitter) was assessed by detection and recognition threshold which were noted on a proforma. The proforma had three columns (baseline, end chemoradiation and follow-up a month after chemoradiation) for each taste and marking from 1 to 8 corresponding to the increasing concentration of the taste solutions (D8-D1) for each taste. D1 was considered as the highest concentration whereas D8 was the lowest concentration of each taste solution.

The cut-off values that were set for each patient for detection and recognition threshold were:

1-8 = able to identify and recognize the taste 0 = unable to identify and recognize any response For Detection threshold (DT) A sample of deionized water and a taste sample was presented to the patient. The order of presentation was randomized for every subject. Participants were asked to indicate which of the sample contains the taste. Detection threshold (DT) was considered as the lowest level at which a subject can perceive a stimulus. This was the minimum concentration at which the subject can detect that there is something different from water, but may not identify its quality. D1 was the highest concentration of solution for each taste and was marked on proforma as 1 and D8 was the minimum concentration and was marked as 8.

For Recognition threshold (RT) Participants were also asked to describe the taste of the solution either salty, sweet, sour or bitter. Recognition threshold was considered as the lowest level of a solution at which a subject can correctly recognize its taste, i.e., sucrose for sweet, sodium chloride (NaCl) for salty, citric acid for sour and caffeine for bitter. D1 was the highest concentration of solution for each taste and was marked as 1 whereas D8 was the minimum concentration and was marked as 8.

Solutions were presented in the increasing order of their concentration and the lowest concentration of solution was marked for each taste that was perceived by the patient. Any subject who was unable to detect the difference between the water and the tastant, the concentration of the taste solution was increased.

Data was entered and analyzed by the IBM SPSS software for windows version 20. Data is shown as mean ± SD for descriptive statistics and as median \[IQR\] for intervention statistics. First, the normality was assessed of all four taste variables by Shapiro-Wilk test. The normality tests are given below.

The baseline characteristics of the test and control group were compared by Chi square and independent t test. To observe difference within the two groups, Wilcoxon Signed Ranks test was applied. To observe the difference between the two groups, Mann-Whitney U test was used. P-value was calculated by Friedman test. Statistical significance was accepted at P \< 0.05.

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.

Efficacy of Zinc on Concurrent Chemo-radiotherapy Induced Taste Alterations

Efficacy of Zinc Sulfate on Concurrent Chemoradiotherapy Induced Taste Alterations in Oral Cancer Patients- A Double Blind Randomized Controlled Trial

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.

Dow University of Health Sciences

Post Graduate Trainee

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intralesional Candidal Antigen Versus Intralesional Zinc Sulphate in Treatment of Cutaneous Warts	NCT03158168	Warts	Candida Antigen Zinc Sulfate	5 Years - 50 Years	Assiut University
Efficacy of Zinc on Concurrent Chemo-radiotherapy Induced Taste Alterations	NCT03824925	Taste, Altered	Placebo oral Zi... Zinc Sulfate 22...	20 Years - 60 Years	Dow University of Health Sciences

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