Health Condition 1: C269- Malignant neoplasm of ill-definedsites within the digestive system Health Condition 2: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
TRAC TMC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Consenting adults with moderate to severe cancer pain in age group of 18-60 years with gastrointestinal or head,neck malignancy. 2. Started on a Buprenorphine 10mcg per hour transdermal patch by the physician as per the pain. 3. Should not have received buprenorphine by any route in past 1 week. 4. Clinically acceptable renal and liver function tests A. Renal function (creatinine clearance greater than or equal to 30ml per min calculated by Cockcroft-gault formula) B. Liver functions total bilirubin less than or equal to 1.5 ULN and serum transaminase level less than or equal to 2.5 ULN or less than or equal to 5 ULN for liver metastasis and or obstructive jaundice. 5. No known allergies to transdermal systems or adhesive patches.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to buprenorphine. 2. Having any skin condition affecting the patch application. 3. Having Fever at the time of application- Axillary Temp more than 99 F 4. Pregnant or breast feeding 5. Currently on benzodiazepines for any reason. 6. Taking any CYP3A4 inhibitors and CYP3A4 inducers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether cachectic patients have similar pharmacokinetics to non-cachectic patients when treated with transdermal buprenorphine patches at day 7.Timepoint: Day 1, 3, 5, and 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine the association of serum albumin and globulins levels with the levels of unbound buprenorphine in blood at day 7.Timepoint: Day 1, 3, 5, and 7;To interpret the changes in the pain scores between cachectic and non - cachectic cancer patients through Numerical rating scale [0-10] at day 7.Timepoint: Day 1, 3, 5, and 7;To interpret the difference Oral Morphine Equivalents in mg/day required as rescue doses taken between the cachectic and non - cachectic cancer patients at day 7.Timepoint: Day 1, 3, 5, and 7;To determine the residual drug in the transdermal patch by comparing the difference in weight of the transdermal patch at day 7.Timepoint: Day 1,3,5 and 7;To determine the maximum plasma concentration achieved Cmax and minimum plasma concentration achieved CminTimepoint: Day 1, 3, 5 and 7 | — |
Countries
India
Contacts
Public ContactDr Varun T M
Advances Centre for Training, Research and Education in Cancer
Outcome results
None listed