CTRI/2021/08/035980CompletedPhase 3
Thalidomide for the prevention of chemotherapy-induced nausea andvomiting (CINV) in the second cycle among patients receiving HighlyEmetogenic Chemotherapy (HEC) and having any nausea in the first cycle:A Randomized, Double-blind, Placebo-controlled trial
Jawaharlal Institute of Postgraduate Medical Education Research0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Age =18 years
- •2. Patients receiving first-line therapy with one of the below HEC regimens:
- •? Anthracycline/Cyclophosphamide combination
- •? Regimens with Cisplatin > 50 mg /m2
- •? ABVD regimen
- •3. Patients must provide written informed consent (including consent for telephonic conversation/questionnaire both in the current and next cycle of chemotherapy).
- •4. ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, and 2
- •at the time of enrolment in the study
- •5. Adequate blood counts and organ functions:
- •? ANC: > 1500/cumm
- •? Total Bilirubin= 1.5 x ULN
- •? AST (SGOT) = 3 x ULN
- •? ALT (SGPT) = 3 x ULN
- •? Serum creatinine = 2 mg/dL or measured creatinine clearance = 40
- •mL/min according to Cockcroft-Gault formula
- •6. Nausea/Vomiting of any grade in the acute/delayed period of first chemotherapy cycle.
- •7. Receiving the same chemotherapy without dose modifications in the second cycle.
- •8. Negative serum/urine pregnancy test in women of childbearing potential
- •(WOCBP) within past 7 days of enrollment and willing to adapt childbirth
- •control throughout the study period.
Exclusion Criteria
- •1. Nausea/vomiting in the past 24 hours (prior to initial enrolment and prior to 2nd HEC cycle).
- •2. The following malignancies will be excluded as they will cause GI symptoms: GI/ Hepato pancreaticobiliary malignancies, ovarian cancers
- •3. Severe neurocognitive impairment.
- •4. Known history of central nervous system organic disorder (e.g., Brain metastasis/malignancy, raised ICT)
- •5. Known psychiatric disorder
- •6. Pre-existing > grade 2 peripheral neuropathy
- •7. Human Immunodeficiency Virus (HIV) infection/and or on anti-retroviral therapy and/ or HCV infection (patients who are anti-HCV positive but have been treated and have undetectable viral load would be permitted to be part of the study).
- •8. Active Hepatitis B infection (in patients who are Hepatitis B carriers, the markers of active infection such as HBeAg and HBV DNA titers must be negative, and patients would be continued on appropriate prophylaxis with antivirals throughout the study).
- •9. Concurrent radiotherapy
- •10. Regular alcohol intake (3 or more drinks equivalent of 45 ml of liquor per week)
- •11. No known hypersensitivity to the study agents
- •12. No known cardiac arrhythmia, uncontrolled CHF, or acute MI within the last 6 months
- •13. No history of uncontrolled DM
Investigators
Similar Trials
Recruiting
Unknown
Hilotherapy for prevention of chemotherapy-induced peripheral polyneuropathy - A unicentric, prospective-controlled, randomized clinical trial for comparison of local hilotherapy vs. no therapy to prevent peripheral polyneuropathy during Taxan-based chemotherapy regimeG62.0C50.9C54C56C53Drug-induced polyneuropathyBreast, unspecifiedMalignant neoplasm of corpus uteriMalignant neoplasm of ovaryMalignant neoplasm of cervix uteriDRKS00027242niversitätsklinikum Ulm150
Not yet recruiting
Not Applicable
Music therapy for chemotherapy induced nausea and vomitingCancerACTRN12622001495718Flinders Foundation24
Completed
Phase 3
Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and VomitingNeoplasmsNCT02203253China Medical University, China642
Unknown
Phase 2
Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) in Patients With Multiple MyelomaMultiple MyelomaNCT00124813University Hospital, Bonn80
Completed
Phase 3
The use of thalidomide as a treatment for cancer cachexiaCachexia associated with upper gastrointestinal adenocarcinomaMalignant neoplasm of other and ill-defined digestive organsCancerISRCTN51456701Portsmouth Hospitals Trust (UK)180
