Taste, AlteredPhase 3NCT03824925
Efficacy of Zinc on Concurrent Chemo-radiotherapy Induced Taste Alterations
A Phase 3 study testing Zinc Sulfate 220 MG in people with Taste, Altered, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Taste, Altered
- What is being tested?
- Zinc Sulfate 220 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2016to 26 Nov 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Zinc Sulfate on Concurrent Chemoradiotherapy Induced Taste Alterations in Oral Cancer Patients- A Double Blind Randomized Controlled Trial
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Taste, Altered
- Being tested
- Placebo oral Zinc capsule, Zinc Sulfate 220 MG
- Keywords
- Taste alterations, zinc sulfate, oral cancer, taste acuity
- Medical subject headings
- Dysgeusia, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo oral Zinc capsuleDrug
Also called Corn Starch
Look alike cap of corn starch as a placebo of Zinc to be given on day 1 of chemo-radiotherapy
Zinc Sulfate 220 MGDrug
Also called Zincat
Zinc sulfate in test group dose was 220 mg which is equivalent to 50 mg of elemental zinc
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Placebo oral Zinc capsule; Drug: Zinc Sulfate 220 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start1 Dec 2016
- Primary completion18 Oct 2018
- Study completion26 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Taste, AlteredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asma Hayat Khan, Dow University of Health Sciences
- Investigators
- Asma Khan, MSc-DS, Principal investigator, Dow Ishrat ul Ebad Institute of Oral Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824925
- Sponsor's protocol ID
- AHKhan
- Status last verified
- Jan 2019
- First submitted
- 23 Jan 2019
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Zinc Sulfate on Concurrent Chemoradiotherapy Induced Taste Alterations in Oral Cancer Patients- A Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03824925
- Acronym / sponsor ID
- AHKhan
- Conditions
- Taste, Altered
- Keywords
- Taste alterations, zinc sulfate, oral cancer, taste acuity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 26 Nov 2018 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo oral zinc capsules | Placebo comparator | Drug: Placebo oral Zinc capsule, Drug: Zinc Sulfate 220 MGGroup 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 |
| Zinc Sulfate 220 MG | Experimental | Drug: Placebo oral Zinc capsule, Drug: Zinc Sulfate 220 MGGroup 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo oral Zinc capsuleAlso: Corn StarchLook alike cap of corn starch as a placebo of Zinc to be given on day 1 of chemo-radiotherapy | Drug | Placebo oral zinc capsules, Zinc Sulfate 220 MG |
| Zinc Sulfate 220 MGAlso: ZincatZinc sulfate in test group dose was 220 mg which is equivalent to 50 mg of elemental zinc | Drug | Placebo oral zinc capsules, Zinc Sulfate 220 MG |
Primary outcome
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
Time frame: 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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asma Khan, MSc-DS principal investigator
Dow Ishrat ul Ebad Institute of Oral Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zinc Sulfate 220 MG in people with Taste, Altered, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.