Dexamethasone-free anti-emetic regimen in multi-day chemotherapy

A randomized, open-label, phase III trial evaluating dexamethasone-free anti-emetic regimen versus standard dexamethasone-containing regimen in patients receiving multi-day highly emetogenic chemotherapy (DEXA-FREE). - Anti Emetic regimen , multi day ,chemo

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096235

Enrollment

176

Registered

2025-10-21

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Experimental Group Experimental Group (DEXA-Free Regimen): Olanzapine: - 5-HT3 receptor antagonist: Palonosetron Ondansetron Granisetron - NK-1 receptor antagonist: Fosaprepitant: Exper

80 mg PO on day 2 and day 3. Subjects will be instructed to use the prescribed rescue antiemetics in the event that nausea and/or vomiting develop during the 192-hour observational period. After the s

8 mg PO on day 2-4. - Olanzapine: 10 mg orally daily on days 1-4. - 5-HT3 receptor antagonist: Palonosetron: 0.25 mg IV on day 1 and day 4 or Ondansetron: 8 mg IV on day 1 to day 3 (in 3-day chemoth

80 mg PO on day 2 and day 3. Subjects will be instructed to use the prescribed rescue antiemetics in the event that nausea and/or vomiting develop during the 192-hour observat

Eligibility

Inclusion criteria

Inclusion criteria: - Age 18-70 years. - ECOG performance status 0 to 2. - Adequate organ function. - Solid malignant tumor No prior chemotherapy - Scheduled for treatment with multi-day highly emetogenic chemotherapy.

Exclusion criteria

Exclusion criteria: - History of using any of the following drugs within 48 hours of enrolment: opioids, aprepitant, Fosaprepitant, 5-HT3 receptor antagonists, steroid, dopamine receptor blockers, anti-depressants or anti-psychotics. - Contraindications to steroid use (e.g., uncontrolled diabetes, Uncontrolled hypertension. - Symptomatic brain metastases or recent use of anti-convulsant. - Known psychiatric illness or recent use of antipsychotics. - Significant QTc prolongation on ECG at baseline. - Patients with gastro-intestinal obstruction.

Design outcomes

Primary

Measure	Time frame
complete control rate (CCR) Timepoint: The overall phase (0-192h).	—

Secondary

Measure	Time frame
-Complete response rate (CRR) -Total control rate (TCR) -Quality of lifeTimepoint: -The acute phase (0-24h)and delayed phase (24h-192h). -the acute (0-24h), delayed (24h-192h) and overall phase (0-192h). - Every visit	—

Countries

India

Contacts

Public ContactDr Amit Joshi

ACTREC,TMC

dramitjoshi74@gmail.com09769331525

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026