Oral Mucositis (Ulcerative)Phase 2NCT04870060
Ability of Curcumin to Decrease Cytokines Involved in Mucositis in the Autologous Transplant
A Phase 2 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 6 Oct 2010to 3 Jul 2015
- Phase
- Phase 2
- 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
- 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) greater 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.
About this study
Official title: A Pharmacokinetic-pharmacodynamic Study Assessing the Ability of Curcumin to Decrease Cytokines Involved in Mucositis in the 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 usually refers to the mucosal ulceration of mouth and throat. However, it is generally accepted that oral mucositis (OM) is in reality the most obvious manifestation of damage or injury elsewhere particularly that of the gut. The incidence of oral mucositis (WHO grades I-IV ) with certain myeloablative conditioning regimens has been reported in up to 90% with range of severe mucositis (WHO grade III/IV) from 10 to 78%.
Mucositis is a complex biological process which occurs in four phases - 1. inflammatory/vascular phase; 2. epithelial phase; 3. ulcerative/bacteriological phase; 4. healing phase. Each phase is interdependent and is the consequence of a series of actions mediated by cytokines, the direct effect of the chemotherapeutic drug on the epithelium, the oral bacterial flora and the status of the patient's bone marrow. Pro-inflammatory cytokines such as interleukin -1 (IL-1), interleukin -6 (IL-6),interleukin-8 (IL-8), interleukin-17 (IL-17), Tumour Necrosis Factor-alpha (TNF-α), Transforming Growth Factor-B (TGF-B),Interferon gamma (IFN-γ) and certain prostaglandins play a central role in its pathogenesis. Chemotherapy, in particular, affects the release of both interleukin-1 (IL-1) and tumor necrosis factor-alpha (TNF-α)from the epithelium. TNF-α is capable of causing tissue damage and may be an accelerating and initiating event in the mucositis process. IL-1 incites an inflammatory response resulting in increased sub-epithelial vascularity with a potential consequent increase in the local levels of cytotoxic agent. On the other hand, cytokines like TGF-β are known inhibitors of epithelial cell proliferation by preventing cell cycle progression and accumulating cells in G1 or G0. For clonogenic stem cells in the intestine, this might render them more resistant to the cytotoxic damage, leaving more clonogenic stem cells to start the regeneration process. Cytokine modulation is the primary mechanism of action of several agents experimented in the recent past to reduce mucositis. For example, Triclosan oral rinse and interleukin-11 (IL-11) therapy reduce ulceration and duration of mucositis by downregulation of PGE2, TNF-α, IL-12 and IFN-γ. It is quite possible that a role exists for transcription factors which modify the genetic expression of cytokines and enzymes which are critical in producing tissue damage. Such factors, such as NF-kappa B, increase the rate of gene transcription and thereby the rate of messenger RNA and protein production. Therefore inhibition of NF-kB could be beneficial in the reduction of mucosal injury.
Currently there are no universal protocols that have been accepted as a standard to prevent and treat OM in the transplant setting. Research is proceeding on several new fronts. Palifermin, recombinant human - keratinocyte growth factor-1, has been shown to the most effective agent so far in few phase II studies.
Accumulating evidence suggests that curcumin inhibits various inflammatory cytokines through inhibition of Nuclear Factor Kappa- β. Curcumin, polyphenol derivative with low toxicity profile, is commonly used in India for its anti-inflammatory actions. It is derived from the plant Curcuma longa. In vitro studies have shown potent anti-inflammatory activity at concentrations of 1 umol/L. Though oral bioavailability of curcumin is poor, in vivo sepsis models in mice have shown good anti-inflammatory activity despite poor plasma levels. Similarly significant decrease of ex vivo production of LPS induced PGE2 levels have been seen in patients treated with curcumin.
Phase I studies in cancer patients have shown that curcumin can be given at doses ranging from 440 mg to 12 grams daily without any toxicity. There was no dose-limiting toxicity; dosing was limited by the number of pills that patients could or would swallow daily. Curcumin used for cancer prevention is seldom administered in a pure chemical form. Rather, it typically consists of three separate curcuminoids consisting of curcumin itself as well as demethoxycurcumin and bisdesmethoxycurcumin. Plasma levels of curcumin and its metabolites such as curcumin glucuronide and curcumin sulphate have been shown to be in the range of 10- 50 ng/ml in patients receiving doses greater than 3.6 gms daily. This peak concentration is seen 1 hour after a given dose. In a recently published study of curcumin in pancreatic cancer little, if any, free or unconjugated curcumin was detected in the plasma of 19 subjects who received a daily dose of 8 g curcumin. An apparent steady-state level of conjugated curcumin in plasma that was achieved by day 3; this level was 22 to 41 ng/mL. Though the peak plasma concentration of curcumin detected is low, at these doses, biological activity demonstrated by either reduction of cytokine levels or decrease in the activity of NK-kB has been seen in all patients.
There are no studies exploring the role of curcumin in mucositis in patients undergoing high dose chemotherapy .The Investigators aim to study the pharmacokinetics and pharmacodynamics of curcumin in the above setting. Patients with mucositis may have difficulty in swallowing tablets. Therefore a lozenge formulation of curcumin will be employed in this study. Lozenges will be manufactured by Pharmanza Herbal Pvt. Ltd (PH). Each lozenge of 1g contains 100mg of curcumin. A capsule formulation of curcumin manufactured by PH containing 27% of curcuminoids was employed in an earlier study in osteogenic sarcoma patients at this centre. Single dose pharmacokinetics with 4g of the formulation yielded peak curcumin concentration of 37.69 ng/ml and half-life of about 2.5 hours - (unpublished data). The time to peak concentration was around 3 hours. Based on this data, a dose of four lozenges (4 gm) twice a day (BID) was deemed necessary and sufficient to achieve the desired inhibition of NF-kB.
- Conditions
- Oral Mucositis (Ulcerative)
- Being tested
- Curcumin Lozenges
- Keywords
- Curcumin, Cytokines, Mucositis, Autologous HSCT, Pharmacokinetics, Pharmacodynamics
- 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 - 4 lozenges to be chewed BD. Each lozenge contained 100 mg of curcumin and the formulation was Solid Lipid Curcumin Particle (SLCP)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients in this arm received only standard supportive care |
| Curcumin | Experimental | Patients in this arm received curcumin lozenges (4 lozenges BD) along with standard supportive care Receives: Drug: Curcumin Lozenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum TNF alpha AUC (0-28)
This will be calculated using serum TNF alpha levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Measured: Day+28
Salivary TNF alpha AUC (0-28)
This will be calculated using salivary TNF alpha levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Measured: Day+28
Serum Interleukin 1 AUC (0-28)
This will be calculated using serum IL-1 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Measured: Day+28
Salivary Interleukin 1 AUC (0-28)
This will be calculated using salivary IL-1 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Measured: Day+28
Serum Interleukin 6 AUC (0-28)
This will be calculated using serum IL-6 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Measured: Day+28
Salivary Interleukin 6 AUC (0-28)
This will be calculated using salivary IL-6 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Measured: Day+28
Serum Interleukin 8 AUC (0-28)
This will be calculated using serum IL-8 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Measured: Day+28
Salivary Interleukin 8 AUC (0-28)
This will be calculated using salivary IL-8 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Measured: Day+28
Serum Interleukin 17 AUC (0-28)
This will be calculated using serum IL-17 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Measured: Day+28
Salivary Interleukin 17 AUC (0-28)
This will be calculated using salivary IL-17 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Measured: Day+28
Serum TGF-beta AUC (0-28)
This will be calculated using serum TGF-beta levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Measured: Day+28
Salivary TGF-beta AUC (0-28)
This will be calculated using salivary TGF-beta levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Measured: Day+28
Serum Interferon gamma AUC (0-28)
This will be calculated using serum IFN-gamma levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Measured: Day+28
Salivary Interferon gamma AUC (0-28)
This will be calculated using salivary IFN-gamma levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Measured: Day+28
Serum Prostaglandin E2 AUC (0-28)
This will be calculated using serum prostaglandin E2 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Measured: Day+28
Salivary Prostaglandin E2 AUC (0-28)
This will be calculated using salivary prostaglandin E2 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Measured: Day+28
Plasma curcumin AUC (0-12 hr)
This will be done using plasma curcumin levels measured 1 hour prior to the first dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (± 15 min) hours post dose.
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 1 hour prior to the first dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (± 15 min) hours post dose.
Measured: Up to 12 hours from 1st dose
Plasma demethoxycurcumin AUC (0-12 hr)
This will be done using plasma demethoxycurcumin levels measured 1 hour prior to the first dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (± 15 min) hours post dose.
Measured: Up to 12 hours from 1st dose
Secondary outcomes (4)
Mucositis incidence
To evaluate the incidence of grade 3 or 4 (WHO) oral mucositis on patients taking oral curcumin in post autologous transplant setting.
Measured: Till hospital discharge or till day+28 (whichever is earlier)
Mucositis duration
To evaluate the duration of grade 3 or 4 (WHO) oral mucositis on patients taking oral curcumin in post autologous transplant setting.
Measured: Till hospital discharge or till day+28 (whichever is earlier)
Diarrhoea incidence
To evaluate the incidence of grade 3 or 4 (CTCAE v 3.0) diarrhea on patients taking oral curcumin in post autologous transplant setting.
Measured: Till hospital discharge or till day+28 (whichever is earlier)
Diarrhoea duration
To evaluate the duration of grade 3 or 4 (CTCAE v 3.0) diarrhea on patients taking oral curcumin in post autologous transplant setting.
Measured: Till hospital discharge or till day+28 (whichever is earlier)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start6 Oct 2010
- Primary completion3 Jul 2015
- Study completion3 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- prospective, single centre, pilot pharmacokinetic and pharmacodynamic study with an adaptive design
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870060
- Sponsor's protocol ID
- 641
- Status last verified
- Apr 2021
- First submitted
- 17 Apr 2021
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Punatar S, Katti K, Rajamanickam D, Patil P, Dhakan C, Bagal B, Gokarn A, Bonda A, Nayak L, Gurjar M, Kannan S, Chiplunkar S, Gota V, Khattry N. Role of Curcumin in Reducing Toxicities Associated With Mucosal Injury Following Melphalan-Based Conditioning in Autologous Transplant Setting. Cell Transplant. 2022 Jan-Dec;31:9636897221086969. doi: 10.1177/09636897221086969.
PubMed 35435039
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic-pharmacodynamic Study Assessing the Ability of Curcumin to Decrease Cytokines Involved in Mucositis in the Autologous Transplant Setting
- ClinicalTrials.gov ID
- NCT04870060
- Acronym / sponsor ID
- 641
- Conditions
- Oral Mucositis (Ulcerative)
- Keywords
- Curcumin, Cytokines, Mucositis, Autologous HSCT, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- 6 Oct 2010 (actual)
- Primary completion
- 3 Jul 2015 (actual)
- Study completion
- 3 Jul 2015 (actual)
- First posted
- 3 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 usually refers to the mucosal ulceration of mouth and throat. However, it is generally accepted that oral mucositis (OM) is in reality the most obvious manifestation of damage or injury elsewhere particularly that of the gut. The incidence of oral mucositis (WHO grades I-IV ) with certain myeloablative conditioning regimens has been reported in up to 90% with range of severe mucositis (WHO grade III/IV) from 10 to 78%.
Mucositis is a complex biological process which occurs in four phases - 1. inflammatory/vascular phase; 2. epithelial phase; 3. ulcerative/bacteriological phase; 4. healing phase. Each phase is interdependent and is the consequence of a series of actions mediated by cytokines, the direct effect of the chemotherapeutic drug on the epithelium, the oral bacterial flora and the status of the patient's bone marrow. Pro-inflammatory cytokines such as interleukin -1 (IL-1), interleukin -6 (IL-6),interleukin-8 (IL-8), interleukin-17 (IL-17), Tumour Necrosis Factor-alpha (TNF-α), Transforming Growth Factor-B (TGF-B),Interferon gamma (IFN-γ) and certain prostaglandins play a central role in its pathogenesis. Chemotherapy, in particular, affects the release of both interleukin-1 (IL-1) and tumor necrosis factor-alpha (TNF-α)from the epithelium. TNF-α is capable of causing tissue damage and may be an accelerating and initiating event in the mucositis process. IL-1 incites an inflammatory response resulting in increased sub-epithelial vascularity with a potential consequent increase in the local levels of cytotoxic agent. On the other hand, cytokines like TGF-β are known inhibitors of epithelial cell proliferation by preventing cell cycle progression and accumulating cells in G1 or G0. For clonogenic stem cells in the intestine, this might render them more resistant to the cytotoxic damage, leaving more clonogenic stem cells to start the regeneration process. Cytokine modulation is the primary mechanism of action of several agents experimented in the recent past to reduce mucositis. For example, Triclosan oral rinse and interleukin-11 (IL-11) therapy reduce ulceration and duration of mucositis by downregulation of PGE2, TNF-α, IL-12 and IFN-γ. It is quite possible that a role exists for transcription factors which modify the genetic expression of cytokines and enzymes which are critical in producing tissue damage. Such factors, such as NF-kappa B, increase the rate of gene transcription and thereby the rate of messenger RNA and protein production. Therefore inhibition of NF-kB could be beneficial in the reduction of mucosal injury.
Currently there are no universal protocols that have been accepted as a standard to prevent and treat OM in the transplant setting. Research is proceeding on several new fronts. Palifermin, recombinant human - keratinocyte growth factor-1, has been shown to the most effective agent so far in few phase II studies.
Accumulating evidence suggests that curcumin inhibits various inflammatory cytokines through inhibition of Nuclear Factor Kappa- β. Curcumin, polyphenol derivative with low toxicity profile, is commonly used in India for its anti-inflammatory actions. It is derived from the plant Curcuma longa. In vitro studies have shown potent anti-inflammatory activity at concentrations of 1 umol/L. Though oral bioavailability of curcumin is poor, in vivo sepsis models in mice have shown good anti-inflammatory activity despite poor plasma levels. Similarly significant decrease of ex vivo production of LPS induced PGE2 levels have been seen in patients treated with curcumin.
Phase I studies in cancer patients have shown that curcumin can be given at doses ranging from 440 mg to 12 grams daily without any toxicity. There was no dose-limiting toxicity; dosing was limited by the number of pills that patients could or would swallow daily. Curcumin used for cancer prevention is seldom administered in a pure chemical form. Rather, it typically consists of three separate curcuminoids consisting of curcumin itself as well as demethoxycurcumin and bisdesmethoxycurcumin. Plasma levels of curcumin and its metabolites such as curcumin glucuronide and curcumin sulphate have been shown to be in the range of 10- 50 ng/ml in patients receiving doses greater than 3.6 gms daily. This peak concentration is seen 1 hour after a given dose. In a recently published study of curcumin in pancreatic cancer little, if any, free or unconjugated curcumin was detected in the plasma of 19 subjects who received a daily dose of 8 g curcumin. An apparent steady-state level of conjugated curcumin in plasma that was achieved by day 3; this level was 22 to 41 ng/mL. Though the peak plasma concentration of curcumin detected is low, at these doses, biological activity demonstrated by either reduction of cytokine levels or decrease in the activity of NK-kB has been seen in all patients.
There are no studies exploring the role of curcumin in mucositis in patients undergoing high dose chemotherapy .The Investigators aim to study the pharmacokinetics and pharmacodynamics of curcumin in the above setting. Patients with mucositis may have difficulty in swallowing tablets. Therefore a lozenge formulation of curcumin will be employed in this study. Lozenges will be manufactured by Pharmanza Herbal Pvt. Ltd (PH). Each lozenge of 1g contains 100mg of curcumin. A capsule formulation of curcumin manufactured by PH containing 27% of curcuminoids was employed in an earlier study in osteogenic sarcoma patients at this centre. Single dose pharmacokinetics with 4g of the formulation yielded peak curcumin concentration of 37.69 ng/ml and half-life of about 2.5 hours - (unpublished data). The time to peak concentration was around 3 hours. Based on this data, a dose of four lozenges (4 gm) twice a day (BID) was deemed necessary and sufficient to achieve the desired inhibition of NF-kB.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, single centre, pilot pharmacokinetic and pharmacodynamic study with an adaptive design
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in this arm received only standard supportive care |
| Curcumin | Experimental | Drug: Curcumin LozengesPatients in this arm received curcumin lozenges (4 lozenges BD) along with standard supportive care |
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
- 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 - 4 lozenges to be chewed BD. Each lozenge contained 100 mg of curcumin and the formulation was Solid Lipid Curcumin Particle (SLCP) | Drug | Curcumin |
Primary outcome
Serum TNF alpha AUC (0-28)
Time frame: Day+28
This will be calculated using serum TNF alpha levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Salivary TNF alpha AUC (0-28)
Time frame: Day+28
This will be calculated using salivary TNF alpha levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Serum Interleukin 1 AUC (0-28)
Time frame: Day+28
This will be calculated using serum IL-1 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Salivary Interleukin 1 AUC (0-28)
Time frame: Day+28
This will be calculated using salivary IL-1 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Serum Interleukin 6 AUC (0-28)
Time frame: Day+28
This will be calculated using serum IL-6 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Salivary Interleukin 6 AUC (0-28)
Time frame: Day+28
This will be calculated using salivary IL-6 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Serum Interleukin 8 AUC (0-28)
Time frame: Day+28
This will be calculated using serum IL-8 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Salivary Interleukin 8 AUC (0-28)
Time frame: Day+28
This will be calculated using salivary IL-8 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Serum Interleukin 17 AUC (0-28)
Time frame: Day+28
This will be calculated using serum IL-17 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Salivary Interleukin 17 AUC (0-28)
Time frame: Day+28
This will be calculated using salivary IL-17 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Serum TGF-beta AUC (0-28)
Time frame: Day+28
This will be calculated using serum TGF-beta levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Salivary TGF-beta AUC (0-28)
Time frame: Day+28
This will be calculated using salivary TGF-beta levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Serum Interferon gamma AUC (0-28)
Time frame: Day+28
This will be calculated using serum IFN-gamma levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Salivary Interferon gamma AUC (0-28)
Time frame: Day+28
This will be calculated using salivary IFN-gamma levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Serum Prostaglandin E2 AUC (0-28)
Time frame: Day+28
This will be calculated using serum prostaglandin E2 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Salivary Prostaglandin E2 AUC (0-28)
Time frame: Day+28
This will be calculated using salivary prostaglandin E2 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14 and then on day+28. Using these values, AUC (0-28) will be calculated using linear trapezoidal model
Plasma curcumin AUC (0-12 hr)
Time frame: Up to 12 hours from 1st dose
This will be done using plasma curcumin levels measured 1 hour prior to the first dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (± 15 min) hours post dose.
Plasma Bis-demethoxycurcumin AUC (0-12 hr)
Time frame: Up to 12 hours from 1st dose
This will be done using plasma Bis-demethoxycurcumin levels measured 1 hour prior to the first dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (± 15 min) hours post dose.
Plasma demethoxycurcumin AUC (0-12 hr)
Time frame: Up to 12 hours from 1st dose
This will be done using plasma demethoxycurcumin levels measured 1 hour prior to the first dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (± 15 min) hours post dose.
4 secondary outcomes
Mucositis incidence
Time frame: Till hospital discharge or till day+28 (whichever is earlier)
Mucositis duration
Time frame: Till hospital discharge or till day+28 (whichever is earlier)
Diarrhoea incidence
Time frame: Till hospital discharge or till day+28 (whichever is earlier)
Diarrhoea duration
Time frame: Till hospital discharge or till day+28 (whichever is earlier)
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 11 Apr 2024.
- Derived from this study: PubMed 35435039Punatar S, Katti K, Rajamanickam D, Patil P, Dhakan C, Bagal B, Gokarn A, Bonda A, Nayak L, Gurjar M, Kannan S, Chiplunkar S, Gota V, Khattry N. Role of Curcumin in Reducing Toxicities Associated With Mucosal Injury Following Melphalan-Based Conditioning in Autologous Transplant Setting. Cell Transplant. 2022 Jan-Dec;31:9636897221086969. doi: 10.1177/09636897221086969.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 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: finished, as of the sponsor's last update on 11 Apr 2024. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Serum TNF alpha AUC (0-28) (time frame: Day+28). The study lists 19 primary outcomes in all. 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 NCT04870060, which also lists 1 linked publication.
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 11 Apr 2024.