Oral Mucositis (Ulcerative)Phase 3NCT04896164
Randomized Trial of Curcumin to Reduce Mucositis in Autologous Transplant Setting
A Phase 3 study testing Curcumin Lozenges in people with Oral Mucositis (Ulcerative), run by Tata Memorial Centre at 1 site in India.
Trial summary
Mucositis is a very common complication in bone marrow transplant setting. It is a result of injury to the gut caused by high dose chemotherapy. Currently there are no universal protocols that have been accepted as a standard to prevent and treat mucositis in the transplant setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis (Ulcerative)
- What is being tested?
- Curcumin Lozenges
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteIndia
- Study dates
- 16 Dec 2018to 16 May 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients 18 years and above.
- Patients who give written informed consent
- Patients with performance status - 0,1 or 2 (ECOG scale)
- Patients receiving any of the following high dose chemotherapy regimens for autologous transplant in any indicated malignant disease.
- Melphalan- 200 mg/m2 or more (MEL-200 mg/m2)
- Busulfan and Melphalan (BuMEL)
Show all 9Show fewer
- Carmustine (BCNU), Etoposide, Cytosine Arabinoside and Melphalan ( BEAM)
- Patients who have creatinine clearance > 50 ml/min
- Patients with serum bilirubin levels < 2mg/dl. and serum liver enzymes (ALT or AST or both) lesser than 5 times the upper limit of normal value.
Who cannot join
- Patients who are on NSAIDs, aspirin, antioxidants or systemic steroids for more than 3 months and the last dose taken within the last one week.
- Patients being treated for active infection at the time of starting high dose chemotherapy.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Centre
Navi Mumbai, Maharashtra, 410210
Navin Khattry, MD, DM, 022-24705000 ext. 5034, nkhattry@gmail.com
About this study
Official title: Phase III Randomized, Double Blind, Placebo Controlled Study of Curcumin to Reduce Mucositis in Autologous Transplant Setting
Mucositis is a very common complication in bone marrow transplant setting. It is a result of injury to the gut caused by high dose chemotherapy. Currently there are no universal protocols that have been accepted as a standard to prevent and treat mucositis in the transplant setting. Post transplant upto 80% of patients suffer from a severe mucositis. Proinflammatory cytokines play a major role in the development of mucositis. Interventions that decrease the levels of these cytokines may be beneficial in preventing mucositis. This study is aimed at evaluating the role of curcumin in reducing cytokine levels and the incidence and duration of mucositis in patients undergoing autologous stem cell transplantation.
Read the detailed description
Mucositis is an inevitable side-effect of intensive conditioning therapy used for hematopoietic stem cell transplantation and affects the quality of life of patients undergoing transplant. The incidence of oral mucositis (WHO grades 3/4 ) with certain myeloablative conditioning regimens has been reported in up to 90% with range of severe mucositis (WHO grade 3/4) from 10 to 78%. Pro-inflammatory cytokines such as IL-1, IL-6, IL-8, IL-17, TNF-α, TGF-B, IFN-γ and certain prostaglandins play a central role in its pathogenesis. Transcription factors such as NF-kappa B, modify the genetic expression of these cytokines and enzymes which are critical in producing tissue damage.
A number of agents and methods have been investigated to prevent or reduce mucositis in transplant setting. Some of them are amifostine, caphasol, palifermin, cryotherapy, chlorhexidine, glutamine, GM-CSF, histamine, misoprostol, laser therapy and traumeel, but only palifermin and cryotherapy have shown significant benefit.
Curcumin, polyphenol derivative with low toxicity profile, is commonly used in India for its anti-inflammatory actions. Curcumin inhibits various inflammatory cytokines through inhibition of Nuclear Factor Kappa- β. It is derived from the plant Curcuma longa. In vitro studies have shown potent anti-inflammatory activity at concentrations of 1 umol/L.
The investigators conducted the first study evaluating the role of curcumin on oral mucositis in transplant setting. In this pilot study (n=40), patients who received curcumin lozenges (n=30) had decreased levels of salivary TGF-β, IL-17 and serum PGE2 compared to patients who did not receive the curcumin lozenges (n=10). Patients who received the curcumin lozenges had higher levels of serum IL-8 which is a prohealing cytokine. The incidence of grade 3 and 4 oral mucositis and diarrhea was less in those who received curcumin lozenges. Curcumin lozenges were also well tolerated and none of the 30 patients who were administered curcumin developed any treatment related grade 3/4 toxicity. This encouraging data is the basis of the current phase III randomized study comparing curcumin lozenges to placebo, to assess the ability of curcumin to reduce the incidence and duration of oral mucositis in patients undergoing autologous bone marrow transplantation.
The formulation being used is a Solip Lipid Curcumin microParticle (SLCP). The formulation is developed by Pharmanza Herbals Pvt. Ltd., Gujarat, India. Gota et al reported a phase I clinical trial of SLCP where upto 4 grams of the formulation containing 20-30% curcumin was evaluated for safety and pharmacokinetics in patients with high-risk osteosarcoma (Ref). The SLCP formulation showed oral bioavailability of curcumin with linear pharmacokinetics. Average peak plasma concentration of 41 ng/mL was observed at the highest dose level of 4g. All doses were well tolerated and no adverse events were observed. Based on these observations (on safety and bioavailability), and the reported anti-inflammatory properties of curcumin, it was envisaged that it could be potentially useful for the prophylaxis and treatment of oral mucositis following high-dose chemotherapy.
- Conditions
- Oral Mucositis (Ulcerative)
- Being tested
- Curcumin Lozenges, Placebo Lozenges
- Keywords
- Curcumin, Mucositis, Autologous stem cell transplant
- Medical subject headings
- Stomatitis, Ulcer, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin LozengesDrug
Also called Longvida (Pharmanza Herbal Pvt Ltd.)
Curcumin lozenges (each containing 100 mg of curcumin) will be given at a dose of 4 lozenges (total dose 400 mg curcumin) BD. Formulation is Solid Lipid Curcumin Particle (SLCP). Oral curcumin lozenges will be given from two days prior to receiving high dose chemotherapy till day+28 of transplant.
Placebo LozengesOther
Placebo lozenges will be given from two days prior to receiving high dose chemotherapy till day+28 of transplant.
| Study group | Role | What they receive |
|---|---|---|
| Investigational arm | Experimental | Patients in the investigational arm will receive curcumin lozenges (4 gm BD containing 400 mg curcumin BD) as prophylaxis from two days prior to receiving high dose chemotherapy . Receives: Drug: Curcumin Lozenges |
| Control arm | Placebo comparator | patients in the control arm will receive matching placebo lozenges from two days prior to receiving high dose chemotherapy Receives: Other: Placebo Lozenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 3 and 4 oral mucositis
In both groups, patients will be evaluated clinically for oral mucositis. The incidence of grade III/IV oral mucositis will be recorded as per WHO grading criteria.
Measured: Day+28
Secondary outcomes (28)
Incidence of any grade of oral mucositis.
In both groups, patients will be evaluated clinically for oral mucositis and grade will be recorded as per WHO grading criteria.
Measured: Day+28
Duration of grade 3 and 4 oral mucositis in both groups
In both groups, duration of oral mucositis will be recorded.
Measured: Day+28
Incidence of use of Total Parenteral Nutrition
Incidence of use of Total Parenteral Nutrition in both groups.
Measured: Day+28
Duration of use of Total Parenteral Nutrition
The duration of use of total parenteral nutrition will be recorded in both groups.
Measured: Day+28
Serum TNF alpha AUC (0-14)
This will be calculated using serum TNF alpha levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model.
Measured: Day+14
Salivary TNF alpha AUC (0-14)
This will be calculated using Salivary TNF alpha levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model.
Measured: Day+14
Serum Interleukin 1 AUC (0-14)
This will be calculated using Serum Interleukin 1 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model.
Measured: Day+14
Salivary Interleukin 1 AUC (0-14)
This will be calculated using Salivary Interleukin 1 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model.
Measured: Day+14
Serum Interleukin 6 AUC (0-14)
This will be calculated using Serum Interleukin 6 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model.
Measured: Day+14
Salivary Interleukin 6 AUC (0-14)
This will be calculated using Salivary Interleukin 6 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model.
Measured: Day+14
Serum Interleukin 8 AUC (0-14)
This will be calculated using Serum Interleukin 8 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model.
Measured: Day+14
Salivary Interleukin 8 AUC (0-14)
This will be calculated using Salivary Interleukin 8 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model.
Measured: Day+14
Serum Interleukin 17 AUC (0-14)
This will be calculated using Serum Interleukin 17 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model.
Measured: Day+14
Salivary Interleukin 17 AUC (0-14)
This will be calculated using Salivary Interleukin 17 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model.
Measured: Day+14
Serum TGF-beta AUC (0-14)
This will be calculated using Serum TGF-beta levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model.
Measured: Day+14
Salivary TGF-beta AUC (0-14)
This will be calculated using Salivary TGF-beta levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model.
Measured: Day+14
Serum Interferon gamma AUC (0-14)
This will be calculated using Serum Interferon gamma levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model.
Measured: Day+14
Salivary Interferon gamma AUC (0-14)
This will be calculated using Salivary Interferon gamma levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model.
Measured: Day+14
Serum Prostaglandin E2 AUC (0-14)
This will be calculated using Serum Prostaglandin E2 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model.
Measured: Day+14
Salivary Prostaglandin E2 AUC (0-14)
This will be calculated using Salivary Prostaglandin E2 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model.
Measured: Day+14
Plasma curcumin AUC (0-12 hr)
This will be done using plasma curcumin levels measured within 1 hr of dosing, 0.5-3 hr, 4-6 hr, and 8 - 12 hr post dose on day 7 of starting curcumin or placebo.
Measured: Up to 12 hours from 1st dose
Plasma Bis-demethoxycurcumin AUC (0-12 hr)
This will be done using plasma Bis-demethoxycurcumin levels measured within 1 hr of dosing, 0.5-3 hr, 4-6 hr, and 8 - 12 hr post dose on day 7 of starting curcumin or placebo.
Measured: Up to 12 hours from 1st dose
Plasma demethoxycurcumin AUC (0-12 hr)
This will be done using plasma demethoxycurcumin levels measured within 1 hr of dosing, 0.5-3 hr, 4-6 hr, and 8 - 12 hr post dose on day 7 of starting curcumin or placebo.
Measured: Up to 12 hours from 1st dose
Duration of use of analgesics for pain due to oral mucositis
Duration of use of analgesics for pain due to oral mucositis in both groups will be recorded.The severity of pain will be measured using the visual analog pain scale.
Measured: Day+28
Incidence of grade 3 and 4 nausea
In both groups, grade of nausea will be recorded as per CTCAE v 4.0 grading criteria.
Measured: Day+28
Incidence of grade 3 and 4 vomiting
In both groups, grade of vomiting will be recorded as per CTCAE v 4.0 grading criteria.
Measured: Day+28
Incidence of grade 3 and 4 diarrhea
In both groups, grade of diarrhea will be recorded as per CTCAE v 4.0 grading criteria.
Measured: Day+28
Duration of hospital stay
The duration of hospital stay will be recorded in both groups.
Measured: From date of hospital admission until date of hospital discharge assessed up to day +28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start16 Dec 2018
- Primary completion16 May 2025 (estimated)
- Study completion16 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Mucositis (Ulcerative)Studies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients receiving high dose chemotherapy with any of the conditioning regimens specified in the inclusion criteria will be randomized in two arms. Central telephonic randomization will be carried out with the help of a computer generated random sequence using permuted blocks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Navin Khattry, Tata Memorial Centre
- Investigators
- Navin Khattry, MD, DM, Principal investigator, Tata Memorial Centre Advanced Centre for Treatment, Research and Education in Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896164
- Sponsor's protocol ID
- 900503
- Other IDs
- CTRI/2018/09/015846
- Status last verified
- Nov 2023
- First submitted
- 15 May 2021
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized, Double Blind, Placebo Controlled Study of Curcumin to Reduce Mucositis in Autologous Transplant Setting
- ClinicalTrials.gov ID
- NCT04896164
- Acronym / sponsor ID
- 900503
- Conditions
- Oral Mucositis (Ulcerative)
- Keywords
- Curcumin, Mucositis, Autologous stem cell transplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- 16 Dec 2018 (actual)
- Primary completion
- 16 May 2025 (estimated)
- Study completion
- 16 May 2025 (estimated)
- First posted
- 21 May 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.
Mucositis is a very common complication in bone marrow transplant setting. It is a result of injury to the gut caused by high dose chemotherapy. Currently there are no universal protocols that have been accepted as a standard to prevent and treat mucositis in the transplant setting. Post transplant upto 80% of patients suffer from a severe mucositis. Proinflammatory cytokines play a major role in the development of mucositis. Interventions that decrease the levels of these cytokines may be beneficial in preventing mucositis. This study is aimed at evaluating the role of curcumin in reducing cytokine levels and the incidence and duration of mucositis in patients undergoing autologous stem cell transplantation.
Detailed description
Mucositis is an inevitable side-effect of intensive conditioning therapy used for hematopoietic stem cell transplantation and affects the quality of life of patients undergoing transplant. The incidence of oral mucositis (WHO grades 3/4 ) with certain myeloablative conditioning regimens has been reported in up to 90% with range of severe mucositis (WHO grade 3/4) from 10 to 78%. Pro-inflammatory cytokines such as IL-1, IL-6, IL-8, IL-17, TNF-α, TGF-B, IFN-γ and certain prostaglandins play a central role in its pathogenesis. Transcription factors such as NF-kappa B, modify the genetic expression of these cytokines and enzymes which are critical in producing tissue damage.
A number of agents and methods have been investigated to prevent or reduce mucositis in transplant setting. Some of them are amifostine, caphasol, palifermin, cryotherapy, chlorhexidine, glutamine, GM-CSF, histamine, misoprostol, laser therapy and traumeel, but only palifermin and cryotherapy have shown significant benefit.
Curcumin, polyphenol derivative with low toxicity profile, is commonly used in India for its anti-inflammatory actions. Curcumin inhibits various inflammatory cytokines through inhibition of Nuclear Factor Kappa- β. It is derived from the plant Curcuma longa. In vitro studies have shown potent anti-inflammatory activity at concentrations of 1 umol/L.
The investigators conducted the first study evaluating the role of curcumin on oral mucositis in transplant setting. In this pilot study (n=40), patients who received curcumin lozenges (n=30) had decreased levels of salivary TGF-β, IL-17 and serum PGE2 compared to patients who did not receive the curcumin lozenges (n=10). Patients who received the curcumin lozenges had higher levels of serum IL-8 which is a prohealing cytokine. The incidence of grade 3 and 4 oral mucositis and diarrhea was less in those who received curcumin lozenges. Curcumin lozenges were also well tolerated and none of the 30 patients who were administered curcumin developed any treatment related grade 3/4 toxicity. This encouraging data is the basis of the current phase III randomized study comparing curcumin lozenges to placebo, to assess the ability of curcumin to reduce the incidence and duration of oral mucositis in patients undergoing autologous bone marrow transplantation.
The formulation being used is a Solip Lipid Curcumin microParticle (SLCP). The formulation is developed by Pharmanza Herbals Pvt. Ltd., Gujarat, India. Gota et al reported a phase I clinical trial of SLCP where upto 4 grams of the formulation containing 20-30% curcumin was evaluated for safety and pharmacokinetics in patients with high-risk osteosarcoma (Ref). The SLCP formulation showed oral bioavailability of curcumin with linear pharmacokinetics. Average peak plasma concentration of 41 ng/mL was observed at the highest dose level of 4g. All doses were well tolerated and no adverse events were observed. Based on these observations (on safety and bioavailability), and the reported anti-inflammatory properties of curcumin, it was envisaged that it could be potentially useful for the prophylaxis and treatment of oral mucositis following high-dose chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients receiving high dose chemotherapy with any of the conditioning regimens specified in the inclusion criteria will be randomized in two arms. Central telephonic randomization will be carried out with the help of a computer generated random sequence using permuted blocks.
| Arm | Type | Receives |
|---|---|---|
| Investigational arm | Experimental | Drug: Curcumin LozengesPatients in the investigational arm will receive curcumin lozenges (4 gm BD containing 400 mg curcumin BD) as prophylaxis from two days prior to receiving high dose chemotherapy . |
| Control arm | Placebo comparator | Other: Placebo Lozengespatients in the control arm will receive matching placebo lozenges from two days prior to receiving high dose chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female patients 18 years and above.
- Patients who give written informed consent
- Patients with performance status - 0,1 or 2 (ECOG scale)
- Patients receiving any of the following high dose chemotherapy regimens for autologous transplant in any indicated malignant disease.
- Patients who have creatinine clearance > 50 ml/min
Key exclusion criteria (2 listed)
- Patients who are on NSAIDs, aspirin, antioxidants or systemic steroids for more than 3 months and the last dose taken within the last one week.
- Patients being treated for active infection at the time of starting high dose chemotherapy.
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 |
|---|---|---|
| Curcumin LozengesAlso: Longvida (Pharmanza Herbal Pvt Ltd.)Curcumin lozenges (each containing 100 mg of curcumin) will be given at a dose of 4 lozenges (total dose 400 mg curcumin) BD. Formulation is Solid Lipid Curcumin Particle (SLCP). Oral curcumin lozenges will be given from two days prior to receiving high dose chemotherapy till day+28 of transplant. | Drug | Investigational arm |
| Placebo LozengesPlacebo lozenges will be given from two days prior to receiving high dose chemotherapy till day+28 of transplant. | Other | Control arm |
Primary outcome
Incidence of grade 3 and 4 oral mucositis
Time frame: Day+28
In both groups, patients will be evaluated clinically for oral mucositis. The incidence of grade III/IV oral mucositis will be recorded as per WHO grading criteria.
28 secondary outcomes
Incidence of any grade of oral mucositis.
Time frame: Day+28
Duration of grade 3 and 4 oral mucositis in both groups
Time frame: Day+28
Incidence of use of Total Parenteral Nutrition
Time frame: Day+28
Duration of use of Total Parenteral Nutrition
Time frame: Day+28
Serum TNF alpha AUC (0-14)
Time frame: Day+14
Salivary TNF alpha AUC (0-14)
Time frame: Day+14
Serum Interleukin 1 AUC (0-14)
Time frame: Day+14
Salivary Interleukin 1 AUC (0-14)
Time frame: Day+14
Serum Interleukin 6 AUC (0-14)
Time frame: Day+14
Salivary Interleukin 6 AUC (0-14)
Time frame: Day+14
Serum Interleukin 8 AUC (0-14)
Time frame: Day+14
Salivary Interleukin 8 AUC (0-14)
Time frame: Day+14
Serum Interleukin 17 AUC (0-14)
Time frame: Day+14
Salivary Interleukin 17 AUC (0-14)
Time frame: Day+14
Serum TGF-beta AUC (0-14)
Time frame: Day+14
Salivary TGF-beta AUC (0-14)
Time frame: Day+14
Serum Interferon gamma AUC (0-14)
Time frame: Day+14
Salivary Interferon gamma AUC (0-14)
Time frame: Day+14
Serum Prostaglandin E2 AUC (0-14)
Time frame: Day+14
Salivary Prostaglandin E2 AUC (0-14)
Time frame: Day+14
Plasma curcumin AUC (0-12 hr)
Time frame: Up to 12 hours from 1st dose
Plasma Bis-demethoxycurcumin AUC (0-12 hr)
Time frame: Up to 12 hours from 1st dose
Plasma demethoxycurcumin AUC (0-12 hr)
Time frame: Up to 12 hours from 1st dose
Duration of use of analgesics for pain due to oral mucositis
Time frame: Day+28
Incidence of grade 3 and 4 nausea
Time frame: Day+28
Incidence of grade 3 and 4 vomiting
Time frame: Day+28
Incidence of grade 3 and 4 diarrhea
Time frame: Day+28
Duration of hospital stay
Time frame: From date of hospital admission until date of hospital discharge assessed up to day +28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- 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.
Navin Khattry, MD, DM principal investigator
Tata Memorial Centre Advanced Centre for Treatment, Research and Education in Cancer
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 Curcumin Lozenges in people with Oral Mucositis (Ulcerative), run by Tata Memorial Centre at 1 site in India.
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 9 inclusion and 2 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 24 Nov 2023. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Navin Khattry, MD, DM (022-27405000 ext. 5034, nkhattry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade 3 and 4 oral mucositis (time frame: Day+28). 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 24 Nov 2023.