This is a study to compare two types of medicines (four drugs vs extended four drugs) for the prevention of nausea and vomiting in chemotherapy for bone marrow transplant patients

Standard vs extended four-drugs for chemotherapy-induced nausea and vomiting prophylaxis in hematopoietic stem cell transplant (SENVIT): A phase III randomized control trial. - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/068139

Enrollment

198

Registered

2024-05-31

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C81-C96- Malignant neoplasms of lymphoid, hematopoietic and related tissue Health Condition 2: D60-D64- Aplastic and other anemias and other bone marrow failure syndromes Health Condition 3: C00-D49- Neoplasms

Interventions

Intervention1: Extended 4 drugs: Cap Aprepitant 125 mg on day 1, 80mg daily till 6 days from the beginning of conditioning regimen or till last day of conditioning regimen whichever is longer. Dexame

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 12yrs- 65 yrs. undergoing: a. Conditioning for autologous hematopoietic stem cell transplant b. Conditioning for allogenic hematopoietic stem cell transplant 2. Weight = 30 kg

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
1A) Complete Response Complete response (CR) was defined as absence of vomiting/ retching and no more than mild nausea during the specified phase. 1B) Vomiting counts Number of vomiting episodes separated by at least 5 minutes of nausea and retching free intervalTimepoint: From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen.	—

Secondary

Measure	Time frame
2) Overall CR rates will be further subdivided into that for acute and delayed phase: 2A) Acute: Any episode occurring after the administration of the first chemotherapy dose until 24 h after the last chemotherapy in the conditioning regimen. 2B) Delayed: Any episode occurring from 24 h up to 6 days after the last dose of chemotherapy in the conditioning regimen. Timepoint: From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen.;3) Complete Protection No nausea, no vomiting and no use of rescue medications for either nausea or vomiting. Timepoint: From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen.;4) Counts of rescue antiemetic doses defined as any therapy given in addition to the standard treatment, for uncontrolled retching/ vomiting, based on clinical judgementTimepoint: From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen.;Individual toxicity episodesTimepoint: From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen.;6) Comparison of quality of life scores between the two armsTimepoint: From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen.	—

Measure

Time frame

2) Overall CR rates will be further subdivided into that for acute and delayed phase: 2A) Acute: Any episode occurring after the administration of the first chemotherapy dose until 24 h after the last chemotherapy in the conditioning regimen. 2B) Delayed: Any episode occurring from 24 h up to 6 days after the last dose of chemotherapy in the conditioning regimen. Timepoint: From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen.;3) Complete Protection No nausea, no vomiting and no use of rescue medications for either nausea or vomiting. Timepoint: From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen.;4) Counts of rescue antiemetic doses defined as any therapy given in addition to the standard treatment, for uncontrolled retching/ vomiting, based on clinical judgementTimepoint: From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen.;Individual toxicity episodesTimepoint: From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen.;6) Comparison of quality of life scores between the two armsTimepoint: From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen.

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Countries

India

Contacts

Public ContactDr Deepam Pushpam

All India Institute of Medical Sciences

deepampushpam@gmail.com9650629370

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026