Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
Mucositis incidence |
To evaluate the incidence of grade 3 or 4 (WHO) oral mucositis on patients taking oral curcumin in post autologous transplant setting. |
Till hospital discharge or till day+28 (whichever is earlier) |
|
Secondary |
Mucositis duration |
To evaluate the duration of grade 3 or 4 (WHO) oral mucositis on patients taking oral curcumin in post autologous transplant setting. |
Till hospital discharge or till day+28 (whichever is earlier) |
|
Secondary |
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. |
Till hospital discharge or till day+28 (whichever is earlier) |
|
Secondary |
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. |
Till hospital discharge or till day+28 (whichever is earlier) |
|