Ability of Curcumin to Decrease Cytokines Involved in Mucositis in the Autologous Transplant

NCT04870060 | Completed Phase 2

• 1 other identifier: 641
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Oral Mucositis (Ulcerative)

Keywords

Curcumin; Cytokines; Mucositis; Autologous HSCT; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (19)

• 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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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.

  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.

  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.

  Up to 12 hours from 1st dose

Secondary Outcomes (4)

• Mucositis incidence

  Till hospital discharge or till day+28 (whichever is earlier)

• Mucositis duration

  Till hospital discharge or till day+28 (whichever is earlier)

• Diarrhoea incidence

  Till hospital discharge or till day+28 (whichever is earlier)

• Diarrhoea duration

  Till hospital discharge or till day+28 (whichever is earlier)

Study Arms (2)

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

Drug: Curcumin Lozenges

Interventions

Curcumin Lozenges DRUG

Curcumin lozenges - 4 lozenges to be chewed BD. Each lozenge contained 100 mg of curcumin and the formulation was Solid Lipid Curcumin Particle (SLCP)

Also known as: Longvida (Pharmanza Herbal Pvt Ltd.)

Curcumin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Tata Memorial Centre

Navi Mumbai, Maharashtra, 410210, India

Location

Related Publications (1)

• 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.

  PMID: 35435039 DERIVED

MeSH Terms

Conditions

Stomatitis; Ulcer; Mucositis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Navin Khattry, MD, DM

  Tata Memorial Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and BMT convener

Model Details: prospective, single centre, pilot pharmacokinetic and pharmacodynamic study with an adaptive design

Study Record Dates

• First Submitted: April 17, 2021
• First Posted: May 3, 2021
• Study Start: October 6, 2010
• Primary Completion: July 3, 2015
• Study Completion: July 3, 2015
• Last Updated: April 11, 2024

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)