Radiation-Induced MucositisPhase 2/3NCT05023863
The Effect of Alpha Lipoic Acid on the Incidence and Severity of Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients
A Phase 2/3 study testing Alpha Lipoic Acid 600 MG Oral Tablets and radiation or concurrent chemoradiation in people with Radiation-Induced Mucositis, run by Ain Shams University at 1 site in Egypt.
Trial summary
A prospective, randomized, controlled, single-blinded study will be conducted at Clinical Oncology department, Ain Shams University Hospitals, assessing the effect of Alpha Lipoic Acid on the incidence and severity of radiotherapy induced oral mucositis in Head and Neck cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Radiation-Induced Mucositis
- What is being tested?
- Alpha Lipoic Acid 600 MG Oral Tablets and radiation or concurrent chemoradiation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to Aug 2022
- Phase
- Phase 2/3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age >18 years.
- Diagnosis of stage I, II, III or IV squamous cell carcinoma, nasopharyngeal carcinoma.
- Measurable disease on CT scan at baseline.
- Planned to receive radiotherapy with a total dose 60 grays or more divided on 30 fractions with or without cisplatin (100 mg/m2, administered intravenously every 21 days for three cycles or 40 mg/m2 administered weekly for up to 7 weeks).
- Adequate liver function (liver transaminases level < 3 times upper normal limits and total bilirubin < 1.5 times upper normal limits).
- Adequate kidney function (estimated glomerular filtration rate >60 ml/min).
- Adequate bone marrow function (WBCs count > 3000 cells/mm3, ANC count >1500 cells/mm3 and platelets count > 100,000 cells/mm3).
Who cannot join
- ● Diagnosis of Thyroid cancer.
- Presence of other primary cancers.
- Treatment with alpha lipoic acid for any other indication.
- Allergy to alpha lipoic acid.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
A prospective, randomized, controlled, single-blinded study will be conducted at Clinical Oncology department, Ain Shams University Hospitals, assessing the effect of Alpha Lipoic Acid on the incidence and severity of radiotherapy induced oral mucositis in Head and Neck cancer patients.
Read the detailed description
All patients presenting to the Clinical Oncology department, Ain Shams University Hospitals, will be assessed for eligibility as follow:
Inclusion criteria:
- Age >18 years.
- Diagnosis of stage I, II, III or IV squamous cell carcinoma, nasopharyngeal carcinoma.
- Measurable disease on CT scan at baseline.
- Planned to receive radiotherapy with a total dose 60 grays or more divided on 30 fractions with or without cisplatin (100 mg/m2, administered intravenously every 21 days for three cycles or 40 mg/m2 administered weekly for up to 7 weeks).
- Adequate liver function (liver transaminases level < 3 times upper normal limits and total bilirubin < 1.5 times upper normal limits).
- Adequate kidney function (estimated glomerular filtration rate >60 ml/min).
- Adequate bone marrow function (WBCs count > 3000 cells/mm3, ANC count >1500 cells/mm3 and platelets count > 100,000 cells/mm3).
Exclusion criteria:
Patients will be excluded if they have any of the following:
- Diagnosis of Thyroid cancer.
- Presence of other primary cancers.
- Treatment with alpha lipoic acid for any other indication.
- Allergy to alpha lipoic acid.
- Pregnant or lactating women. Eligible patients will be randomized to either… Alpha Lipoic Acid Group (intervention group): 35 patients will receive radiation therapy with or without platinum-based chemotherapy in addition to alpha lipoic acid 600 mg tablets twice daily (throughout the radiotherapy period). The medication will be brought from EVA company ( an Egyptian drug company ) under the trade name of thiotacid 600 mg tablets.
Control Group: 35 Patients will receive radiation therapy with or without platinum-based chemotherapy plus placebo tablets of thiotacid throughout the radiation period
All patients will be followed up weekly to assess the incidence and severity of radiation induced oral mucositis using the radiotherapy oncology group criteria also blood samples will be drawn at baseline , after three weeks (middle of radiation period) at the end of radiation period to asses changes in CRP and TAC levels
- Conditions
- Radiation-Induced Mucositis
- Being tested
- Alpha Lipoic Acid 600 MG Oral Tablets, Placebo tablets, radiation or concurrent chemoradiation
- Keywords
- Head and Neck cancer, Alpha Lipoic Acid, Mucositis
- Medical subject headings
- Head and Neck Neoplasms, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha Lipoic Acid 600 MG Oral TabletsDrug
Alpha Lipoic Acid (ALA) is a drug which has been used in treatment of diabetic neuropathy . It act through enhancing nitric oxide-mediated endothelium-dependent vasodilation, thus improving microcirculation in patients with diabetic polyneuropathy. It is considered a safe drug, generally with a daily dose of 200 to 2400 mg/day is considered tolerable without significant side effects. Only gastrointestinal tracts side effects like nausea, vomiting, dyspepsia and abdominal pain have been described in some clinical trials. Also FDA experts confirm its safety and efficacy in humans
Placebo tabletsOther
placebo tablets of the same generic of active drug which contain all the same ingredients as active tablets except alpha lipoic acid
radiation or concurrent chemoradiationRadiation
radiation or concurrent radiotherapy plus platinum-based chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Alpha Lipoic Acid Group (intervention group) | Active comparator | 35 patients will receive radiation therapy with or without platinum-based chemotherapy in addition to alpha lipoic acid 600 mg tablets twice daily (throughout the radiotherapy period). . Receives: Drug: Alpha Lipoic Acid 600 MG Oral Tablets; Radiation: radiation or concurrent chemoradiation |
| Control Group | Placebo comparator | 35 Patients will receive radiation therapy with or without platinum-based chemotherapy in addition to placebo tablets twice daily (throughout the radiotherapy period) Receives: Other: Placebo tablets; Radiation: radiation or concurrent chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of radiation induced oral mucositis
The patients will be followed up during the whole period of radiation and up to six weeks after radiation to evaluate the incidence and severity of radiation induced mucositis. Severity will be assessed by the oncologist using radiotherapy oncology group criteria (RTOG criteria)
Measured: 4 months
Secondary outcomes (1)
Time to develop grade III or IV radiation induced oral mucositis:
For each patient, the time from the start of radiotherapy till the development of grade III or IV RIOM will be recorded.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Radiation-Induced MucositisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized, controlled, single blinded study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bishoy Anwar, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023863
- Sponsor's protocol ID
- PHLCLINICAL
- Status last verified
- Aug 2021
- First submitted
- 1 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al Abdan M. Alfa-lipoic acid controls tumor growth and modulates hepatic redox state in Ehrlich-ascites-carcinoma-bearing mice. ScientificWorldJournal. 2012;2012:509838. doi: 10.1100/2012/509838. Epub 2012 May 1.
PubMed 23002387Bloomer WD, Hellman S. Normal tissue responses to radiation therapy. N Engl J Med. 1975 Jul 10;293(2):80-3. doi: 10.1056/NEJM197507102930206. No abstract available.
PubMed 1093032Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
PubMed 19097774Elsabagh HH, Moussa E, Mahmoud SA, Elsaka RO, Abdelrahman H. Efficacy of Melatonin in prevention of radiation-induced oral mucositis: A randomized clinical trial. Oral Dis. 2020 Apr;26(3):566-572. doi: 10.1111/odi.13265. Epub 2020 Jan 15.
PubMed 31869853Gillison ML. Human papillomavirus-related diseases: oropharynx cancers and potential implications for adolescent HPV vaccination. J Adolesc Health. 2008 Oct;43(4 Suppl):S52-60. doi: 10.1016/j.jadohealth.2008.07.002.
PubMed 18809146Jung JH, Jung J, Kim SK, Woo SH, Kang KM, Jeong BK, Jung MH, Kim JH, Hahm JR. Alpha lipoic acid attenuates radiation-induced thyroid injury in rats. PLoS One. 2014 Nov 17;9(11):e112253. doi: 10.1371/journal.pone.0112253. eCollection 2014.
PubMed 25401725Kim H, Yoo WS, Jung JH, Jeong BK, Woo SH, Kim JH, Kim SJ. Alpha-Lipoic Acid Ameliorates Radiation-Induced Lacrimal Gland Injury through NFAT5-Dependent Signaling. Int J Mol Sci. 2019 Nov 13;20(22):5691. doi: 10.3390/ijms20225691.
PubMed 31766286Kim JH, Jeong BK, Jang SJ, Yun JW, Jung MH, Kang KM, Kim TG, Woo SH. Alpha-Lipoic Acid Ameliorates Radiation-Induced Salivary Gland Injury by Preserving Parasympathetic Innervation in Rats. Int J Mol Sci. 2020 Mar 25;21(7):2260. doi: 10.3390/ijms21072260.
PubMed 32218158Kusiak A, Jereczek-Fossa BA, Cichonska D, Alterio D. Oncological-Therapy Related Oral Mucositis as an Interdisciplinary Problem-Literature Review. Int J Environ Res Public Health. 2020 Apr 3;17(7):2464. doi: 10.3390/ijerph17072464.
PubMed 32260309Logan RM, Stringer AM, Bowen JM, Gibson RJ, Sonis ST, Keefe DM. Serum levels of NFkappaB and pro-inflammatory cytokines following administration of mucotoxic drugs. Cancer Biol Ther. 2008 Jul;7(7):1139-45. doi: 10.4161/cbt.7.7.6207. Epub 2008 Apr 29.
PubMed 18535404Lott IT, Doran E, Nguyen VQ, Tournay A, Head E, Gillen DL. Down syndrome and dementia: a randomized, controlled trial of antioxidant supplementation. Am J Med Genet A. 2011 Aug;155A(8):1939-48. doi: 10.1002/ajmg.a.34114. Epub 2011 Jul 7.
PubMed 21739598Mallick S, Benson R, Rath GK. Radiation induced oral mucositis: a review of current literature on prevention and management. Eur Arch Otorhinolaryngol. 2016 Sep;273(9):2285-93. doi: 10.1007/s00405-015-3694-6. Epub 2015 Jun 27.
PubMed 26116012Marur S, Forastiere AA. Head and Neck Squamous Cell Carcinoma: Update on Epidemiology, Diagnosis, and Treatment. Mayo Clin Proc. 2016 Mar;91(3):386-96. doi: 10.1016/j.mayocp.2015.12.017.
PubMed 26944243Moreira PI, Harris PL, Zhu X, Santos MS, Oliveira CR, Smith MA, Perry G. Lipoic acid and N-acetyl cysteine decrease mitochondrial-related oxidative stress in Alzheimer disease patient fibroblasts. J Alzheimers Dis. 2007 Sep;12(2):195-206. doi: 10.3233/jad-2007-12210.
PubMed 17917164Pearman TP, Beaumont JL, Paul D, Abernethy AP, Jacobsen PB, Syrjala KL, Von Roenn J, Cella D. Evaluation of treatment- and disease-related symptoms in advanced head and neck cancer: validation of the national comprehensive cancer network-functional assessment of cancer therapy-head and neck cancer symptom index-22 (NFHNSI-22). J Pain Symptom Manage. 2013 Jul;46(1):113-20. doi: 10.1016/j.jpainsymman.2012.06.004. Epub 2012 Sep 25.
PubMed 23017622
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alpha Lipoic Acid on the Incidence and Severity of Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT05023863
- Acronym / sponsor ID
- PHLCLINICAL
- Conditions
- Radiation-Induced Mucositis
- Keywords
- Head and Neck cancer, Alpha Lipoic Acid, Mucositis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 27 Aug 2021 (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.
A prospective, randomized, controlled, single-blinded study will be conducted at Clinical Oncology department, Ain Shams University Hospitals, assessing the effect of Alpha Lipoic Acid on the incidence and severity of radiotherapy induced oral mucositis in Head and Neck cancer patients.
Detailed description
All patients presenting to the Clinical Oncology department, Ain Shams University Hospitals, will be assessed for eligibility as follow:
Inclusion criteria:
- Age >18 years.
- Diagnosis of stage I, II, III or IV squamous cell carcinoma, nasopharyngeal carcinoma.
- Measurable disease on CT scan at baseline.
- Planned to receive radiotherapy with a total dose 60 grays or more divided on 30 fractions with or without cisplatin (100 mg/m2, administered intravenously every 21 days for three cycles or 40 mg/m2 administered weekly for up to 7 weeks).
- Adequate liver function (liver transaminases level < 3 times upper normal limits and total bilirubin < 1.5 times upper normal limits).
- Adequate kidney function (estimated glomerular filtration rate >60 ml/min).
- Adequate bone marrow function (WBCs count > 3000 cells/mm3, ANC count >1500 cells/mm3 and platelets count > 100,000 cells/mm3).
Exclusion criteria:
Patients will be excluded if they have any of the following:
- Diagnosis of Thyroid cancer.
- Presence of other primary cancers.
- Treatment with alpha lipoic acid for any other indication.
- Allergy to alpha lipoic acid.
- Pregnant or lactating women. Eligible patients will be randomized to either… Alpha Lipoic Acid Group (intervention group): 35 patients will receive radiation therapy with or without platinum-based chemotherapy in addition to alpha lipoic acid 600 mg tablets twice daily (throughout the radiotherapy period). The medication will be brought from EVA company ( an Egyptian drug company ) under the trade name of thiotacid 600 mg tablets.
Control Group: 35 Patients will receive radiation therapy with or without platinum-based chemotherapy plus placebo tablets of thiotacid throughout the radiation period
All patients will be followed up weekly to assess the incidence and severity of radiation induced oral mucositis using the radiotherapy oncology group criteria also blood samples will be drawn at baseline , after three weeks (middle of radiation period) at the end of radiation period to asses changes in CRP and TAC levels
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, randomized, controlled, single blinded study
| Arm | Type | Receives |
|---|---|---|
| Alpha Lipoic Acid Group (intervention group) | Active comparator | Drug: Alpha Lipoic Acid 600 MG Oral Tablets, Radiation: radiation or concurrent chemoradiation35 patients will receive radiation therapy with or without platinum-based chemotherapy in addition to alpha lipoic acid 600 mg tablets twice daily (throughout the radiotherapy period). . |
| Control Group | Placebo comparator | Other: Placebo tablets, Radiation: radiation or concurrent chemoradiation35 Patients will receive radiation therapy with or without platinum-based chemotherapy in addition to placebo tablets twice daily (throughout the radiotherapy period) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Age >18 years.
Key exclusion criteria (5 listed)
- ● Diagnosis of Thyroid cancer.
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 |
|---|---|---|
| Alpha Lipoic Acid 600 MG Oral TabletsAlpha Lipoic Acid (ALA) is a drug which has been used in treatment of diabetic neuropathy . It act through enhancing nitric oxide-mediated endothelium-dependent vasodilation, thus improving microcirculation in patients with diabetic polyneuropathy. It is considered a safe drug, generally with a daily dose of 200 to 2400 mg/day is considered tolerable without significant side effects. Only gastrointestinal tracts side effects like nausea, vomiting, dyspepsia and abdominal pain have been described in some clinical trials. Also FDA experts confirm its safety and efficacy in humans | Drug | Alpha Lipoic Acid Group (intervention group) |
| Placebo tabletsplacebo tablets of the same generic of active drug which contain all the same ingredients as active tablets except alpha lipoic acid | Other | Control Group |
| radiation or concurrent chemoradiationradiation or concurrent radiotherapy plus platinum-based chemotherapy | Radiation | Alpha Lipoic Acid Group (intervention group), Control Group |
Primary outcome
Incidence and severity of radiation induced oral mucositis
Time frame: 4 months
The patients will be followed up during the whole period of radiation and up to six weeks after radiation to evaluate the incidence and severity of radiation induced mucositis. Severity will be assessed by the oncologist using radiotherapy oncology group criteria (RTOG criteria)
1 secondary outcome
Time to develop grade III or IV radiation induced oral mucositis:
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Background: PubMed 23002387Al Abdan M. Alfa-lipoic acid controls tumor growth and modulates hepatic redox state in Ehrlich-ascites-carcinoma-bearing mice. ScientificWorldJournal. 2012;2012:509838. doi: 10.1100/2012/509838. Epub 2012 May 1.
- Background: PubMed 1093032Bloomer WD, Hellman S. Normal tissue responses to radiation therapy. N Engl J Med. 1975 Jul 10;293(2):80-3. doi: 10.1056/NEJM197507102930206. No abstract available.
- Background: PubMed 19097774Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
- Background: PubMed 31869853Elsabagh HH, Moussa E, Mahmoud SA, Elsaka RO, Abdelrahman H. Efficacy of Melatonin in prevention of radiation-induced oral mucositis: A randomized clinical trial. Oral Dis. 2020 Apr;26(3):566-572. doi: 10.1111/odi.13265. Epub 2020 Jan 15.
- Background: PubMed 18809146Gillison ML. Human papillomavirus-related diseases: oropharynx cancers and potential implications for adolescent HPV vaccination. J Adolesc Health. 2008 Oct;43(4 Suppl):S52-60. doi: 10.1016/j.jadohealth.2008.07.002.
- Background: PubMed 25401725Jung JH, Jung J, Kim SK, Woo SH, Kang KM, Jeong BK, Jung MH, Kim JH, Hahm JR. Alpha lipoic acid attenuates radiation-induced thyroid injury in rats. PLoS One. 2014 Nov 17;9(11):e112253. doi: 10.1371/journal.pone.0112253. eCollection 2014.
- Background: PubMed 31766286Kim H, Yoo WS, Jung JH, Jeong BK, Woo SH, Kim JH, Kim SJ. Alpha-Lipoic Acid Ameliorates Radiation-Induced Lacrimal Gland Injury through NFAT5-Dependent Signaling. Int J Mol Sci. 2019 Nov 13;20(22):5691. doi: 10.3390/ijms20225691.
- Background: PubMed 32218158Kim JH, Jeong BK, Jang SJ, Yun JW, Jung MH, Kang KM, Kim TG, Woo SH. Alpha-Lipoic Acid Ameliorates Radiation-Induced Salivary Gland Injury by Preserving Parasympathetic Innervation in Rats. Int J Mol Sci. 2020 Mar 25;21(7):2260. doi: 10.3390/ijms21072260.
- Background: PubMed 32260309Kusiak A, Jereczek-Fossa BA, Cichonska D, Alterio D. Oncological-Therapy Related Oral Mucositis as an Interdisciplinary Problem-Literature Review. Int J Environ Res Public Health. 2020 Apr 3;17(7):2464. doi: 10.3390/ijerph17072464.
- Background: PubMed 18535404Logan RM, Stringer AM, Bowen JM, Gibson RJ, Sonis ST, Keefe DM. Serum levels of NFkappaB and pro-inflammatory cytokines following administration of mucotoxic drugs. Cancer Biol Ther. 2008 Jul;7(7):1139-45. doi: 10.4161/cbt.7.7.6207. Epub 2008 Apr 29.
- Background: PubMed 21739598Lott IT, Doran E, Nguyen VQ, Tournay A, Head E, Gillen DL. Down syndrome and dementia: a randomized, controlled trial of antioxidant supplementation. Am J Med Genet A. 2011 Aug;155A(8):1939-48. doi: 10.1002/ajmg.a.34114. Epub 2011 Jul 7.
- Background: PubMed 26116012Mallick S, Benson R, Rath GK. Radiation induced oral mucositis: a review of current literature on prevention and management. Eur Arch Otorhinolaryngol. 2016 Sep;273(9):2285-93. doi: 10.1007/s00405-015-3694-6. Epub 2015 Jun 27.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Alpha Lipoic Acid 600 MG Oral Tablets and radiation or concurrent chemoradiation in people with Radiation-Induced Mucositis, run by Ain Shams University at 1 site in Egypt.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Aug 2021. 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 Egypt. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bishoy Anwar Rizk-Allah, bachelor (01228016836, bishoyanwar.rezk@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of radiation induced oral mucositis (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05023863, which also lists 20 linked publications.
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 27 Aug 2021.