Aprepitant as add-on to standard antiemetic regimen for concurrent chemoradiotherapy induced nausea vomiting in head and neck cancer

Abstract

BACKGROUND

There is dearth of literature with respect to specific antiemetic guidelines for the concurrent chemoradiotherapy (CCRT) induced nausea and vomiting. Evidence regarding the routine use of NK₁ receptor antagonists in CCRT settings also remains limited.

AIM

To evaluate the efficacy and safety of aprepitant as add-on to standard antiemetic therapy (ondansetron and dexamethasone) for prevention of CCRT-induced nausea and vomiting in patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC).

METHODS

This randomized, double-blind, placebo controlled clinical trial was conducted at a regional cancer institute in a public tertiary care hospital in North India. Treatment naïve patients with histologically confirmed LAHNSCC started on weekly cisplatin-based CCRT were randomized into 2 groups viz. Group A: Aprepitant plus standard antiemetic regimen; and Group B: Standard antiemetic regimen. Patients were followed up till four days after CCRT cycle. Primary outcome of complete response was assessed during acute (0-24 hours) and delayed phase (day 2-5). Secondary outcomes included complete protection (CP), degree of nausea and vomiting, rescue medication use and safety analysis.

RESULTS

Eighty-six patients were enrolled (43 per group). The aprepitant regimen significantly improved acute-phase complete response (97.7% vs 81.4%; P = 0.014). Delayed-phase complete response was numerically higher in the aprepitant group (74.4% vs 69.7%) but the difference was not statistically significant (P = 0.63). CP was better in the aprepitant group. Mean nausea intensity score and rescue medication use were lower in Group A. Both regimens were well tolerated with comparable adverse events.

CONCLUSION

Addition of aprepitant provides superior acute-phase control of CCRT-induced nausea and vomiting and improves nausea without compromising safety. Larger studies with multiple CCRT cycles are needed to further provide confirmatory evidence in this direction.

Key Words: Concurrent chemoradiotherapy; Aprepitant; Head and neck cancer; Antiemetic regimen; Complete response; Complete protection; Rescue medication

Core Tip: This is the first randomised, double-blind, placebo-controlled trial evaluating aprepitant as add-on to standard antiemetic therapy in locally advanced head and neck squamous cell carcinoma patients receiving weekly cisplatin-based concurrent chemoradiotherapy. Addition of aprepitant significantly improved acute-phase complete response (97.7% vs 81.4%), complete protection in both phases, and nausea intensity without compromising safety or tolerability, supporting consideration of neurokinin-1 receptor antagonists as part of antiemetic prophylaxis in this setting, while larger studies are needed to confirm benefits during the delayed phase.

INTRODUCTION

Cisplatin-based concurrent chemoradiotherapy (CCRT) is the standard treatment modality for locally advanced head and neck squamous cell carcinoma (LA-HNSCC), offering improved loco-regional control and survival[1]. However, the synergistic emetogenic effects of chemotherapy and radiotherapy when used concomitantly significantly increases the incidence, severity and duration of nausea and vomiting compared to either treatment modality used alone, resulting in greater symptom burden, increased use of rescue medication and poor quality of life[2]. Cisplatin remains the most commonly used chemotherapeutic agent in the management of LA-HNSCC because of its proven radio-sensitizing properties. It is classified as a highly emetogenic chemotherapy (HEC) agent, with an emetogenic risk exceeding 90% in the absence of prophylaxis. The incidences of nausea and vomiting with cisplatin-based CCRT in head and neck cancer have been reported as 48%-66% and 30%-47%, respectively[3-6]. Hence, there is a clear need to evaluate effective, safe and feasible antiemetic strategies to address nausea and vomiting associated with CCRT.

Recent advances in the molecular characterization of HNSCC have highlighted substantial biological heterogeneity, with distinct tumour ecosystems, metabolic signatures, and immune microenvironment profiles influencing prognosis and response to therapy. These findings are facilitating the development of more personalized therapeutic approaches, including biomarker-driven treatment strategies and novel immunomodulatory interventions. Nevertheless, concurrent cisplatin-based CCRT remains the standard treatment for the majority of patients with locally advanced disease, making optimization of supportive care, including effective prevention of treatment-related nausea and vomiting, an important component of comprehensive cancer management[7-9]. The conventional standard antiemetic regimen, comprising a 5-HT3 receptor antagonist (5-HT3 RA; commonly ondansetron) in combination with dexamethasone, has been shown to provide effective protection against acute emesis in a majority of patients. While second-generation 5-HT3 RA such as palonosetron have demonstrated improved control of delayed chemotherapy induced nausea and vomiting (CINV), particularly due to their longer half-life, first-generation agents like ondansetron continue to be widely used owing to their lower cost and acceptable efficacy[10,11]. Corticosteroids, especially dexamethasone, remain a cornerstone of both acute and delayed CINV management and are believed to enhance the efficacy of other antiemetics through central and peripheral mechanisms. A major advancement in antiemetic therapy was the introduction of selective neurokinin-1 receptor antagonists (NK1RA), which block substance P- mediated emetic signaling at both central and peripheral levels and have demonstrated significant improvement in complete response when added to the standard 5-HT3RA-dexamethasone regimen[12-14]. Triple regimen comprising of 5-HT3RA, dexamethasone and NK1RA is recommended by the current Multinational Association of Supportive Care in Cancer (MASCC)/European Society for Medical Oncology (ESMO) and National Comprehensive Cancer Network guidelines to prevent nausea and vomiting associated with HEC e.g., cisplatin[15-18].

A review of the existing literature shows that while many studies have been conducted to explore the efficacy of NK1RA such as aprepitant or fosaprepitant—either alone or in various combinations with 5-HT3 receptor antagonists, corticosteroids, or olanzapine—for the prophylaxis of CINV and radiotherapy-induced nausea and vomiting[19-24], evidence specifically addressing their role in CCRT remains limited. Few studies have evaluated the use of different NK1 RA in the setting of HEC based CCRT regimens across different cancers[1,25-27]. In this context, the present study aimed to compare the efficacy and safety of aprepitant as an add-on to the standard antiemetic regimen compared to the standard antiemetic regimen alone for the prevention of CCRT induced nausea and vomiting in patients with LAHNSCC.

MATERIALS AND METHODS

Study design and setting

This was a randomized, double blind, placebo controlled clinical trial, conducted collaboratively by the Departments of Pharmacology and Radiation Oncology at Pt. B D Sharma Postgraduate Institute of Medical Sciences, Rohtak (Haryana) from June 15, 2024 to January 15, 2026. The study was carried out in accordance with the principles of Good Clinical Practice and Declaration of Helsinki. Prior ethical clearance was obtained from the institute biomedical research ethics committee (BREC/24/364) and the trial was prospectively registered with the clinical trials registry of India (CTRI/2024/06/068878).

Study participants

Patients visiting the outpatient department and admitted in inpatient wards of Radiation oncology department of our tertiary care hospital were screened for potential inclusion in the study. The inclusion criteria were: (1) Male or female patients 18 to 80 years of age; (2) Previously untreated histologically confirmed squamous cell carcinoma of the head and neck of stages III-IVB, based on the American Joint Committee on Cancer 7^th Edition (AJCC 7^th); (3) Eastern Cooperative Oncology Group performance status 0-1; (4) Adequate organ and bone marrow function, normal hemogram & blood biochemistry; (5) Ability to swallow tablets; and (6) Willing to participate in the study and give written informed consent. The exclusion criteria were: (1) Receiving any other CCRT regimen apart from weekly cisplatin based CCRT; (2) Advanced stage malignancies (> stage IVB); (3) History of nausea and emesis within 24 hours before the start of CCRT; (4) History of severe cardiovascular, pulmonary, diabetic, mental, and other diseases that could cause nausea & vomiting; (5) Any on-going concurrent therapy with corticosteroids/benzodiazepines; and (6) Pregnant or lactating females.

Study conduct

Eligible patients were randomised in 1:1 ratio using block randomisation with block size of four technique into either of the two study arms: (1) Group A: Aprepitant as add-on to standard antiemetic regimen; and (2) Group B: Standard antiemetic regimen alone. The doses, duration, and schedule of anti-emetics followed MASSC/ESMO guidelines for HEC[16] (Table 1). Allocation sequence was generated by an individual personnel who was not directly involved in participant enrolment. Allocation concealment was done using sequentially numbered opaque sealed envelopes. Blinding for capsule aprepitant was ensured by matching placebo capsule containing multivitamins; both the patient and investigator performing outcome assessment were blinded to study treatment. All the patients received cisplatin-based CCRT regimen comprising of 50 mg weekly cisplatin intravenously and radiation dose of 66 Gy in 33 fractions over 6.3 weeks (5 days/week with 2 Gy per fraction) using Cobalt-60 teletherapy machine. The patients were followed up till four days after CCRT and contacted telephonically after hospital discharge. All the parameters - frequency, intensity and duration of nausea, frequency of vomiting, use of any rescue medication, treatment adherence in acute phase (within 24 hours of chemo-radiotherapy) and delayed phase (24 hours up to fifth day from day of receiving CCRT) were carefully recorded in each patients’ daily diary as daily recordings. Any adverse events related to the therapy as well as antiemetic regimens were also noted.

Table 1 Details of antiemetic regimens in the two study groups.

Group A (aprepitant + ondansetron + dexamethasone)	Group B (ondansetron + dexamethasone)
On day 1 (half hour before CCRT)
Inj. ondansetron 8 mg IV	Inj. ondansetron 8 mg IV
Inj. dexamethasone 12 mg IV	Inj. dexamethasone 12 mg IV
Cap aprepitant 125 mg OD	Cap placebo OD
After CCRT
Tab. ondansetron 8 mg	Tab. ondansetron 8 mg
On day 2, 3, 4, and 5
Cap Aprepitant 80 mg OD on day 2, 3	Cap placebo OD on day 2, 3
Tab ondansetron 8 mg BD on days 2, 3, 4, and 5	Tab ondansetron 8 mg BD on days 2, 3, 4, and 5

CCRT: Concurrent chemo-radiotherapy; OD: Once daily; BD: Twice daily; IV: Intravenous.

Study outcomes

Primary outcome was complete response (CR) defined as no emesis and no use of rescue medication. Secondary outcomes included: (1) Complete protection (CP) defined as no emesis, no rescue medication, and no more than mild nausea; (2) Degree of nausea & vomiting using MASSC Antiemesis Tool (MAT) and Common Terminology Criteria for Adverse Events (CTCAE); (3) Treatment adherence; and (4) Use of any rescue anti-emetic therapy.

Sample size calculation

Sample size was calculated on the basis of the study by Wang et al[1]. Considering the proportion of patients achieving the primary end point i.e., complete response in triple and dual regimen arms as 86% and 60% respectively, type 1 error at a rate of 5% and 80% power, the sample size was calculated as 43 patients in one arm, thereby requiring 86 patients in total. Considering 10% drop out rate, approximately 95 patients in both the study arms were needed to be enrolled.

Statistical analysis

Efficacy analysis was done using the modified intention-to-treat (mITT) principle and patients who had at least one post-treatment assessment on day 1 (for acute-phase analysis) and day 2 to 5 (for delayed and overall phase analysis) were included in the analysis. Safety analysis was done as per protocol principle and included patients who completed the follow up. Categorical variables were expressed as frequencies and percentages, while continuous variables were summarized as mean with standard deviation or median with interquartile range, as appropriate. Comparison of proportions of patients achieving complete response, complete protection, and those requiring rescue antiemetic therapy between the two groups was performed using the χ² test/Fisher’s exact test depending on the data. The degree of nausea and vomiting between the two groups was analysed using the Mann-Whitney U test. Statistical analysis was carried out using IBM SPSS Statistics (Trial Version 31.0.1.0); P value of less than 0.05 was considered statistically significant.

RESULTS

Out of 925 head and neck cancer patients registered in the Department of Radiation oncology during study period, 86 were eligible and randomised to two study arms (n = 43 in each arm) (Figure 1). All the patients had at least one post-treatment assessment on day 1 (for acute phase analysis) and day 2 to 5 (for delayed and overall phase analysis) and were thus included in efficacy analysis as per mITT principle. 1 patient in group A and 4 patients in group B were lost to follow up, thus 42 and 39 patients in the two groups, respectively, were included in safety analysis.

Figure 1 CONSORT chart. ECOG: Eastern Cooperative Oncology Group; CCRT: Concurrent chemoradiotherapy.

The study population predominantly comprised of males in both groups with higher age in group A (P = 0.02). There was higher frequency of oral cavity tumours in group B (18.6% vs 4.65% in group A; P value 0.04). Other baseline disease and clinical characteristics were comparable in two groups (Table 2). The proportion of patients achieving CR was significantly higher in group A than group B during acute phase (P = 0.014) while the difference was not significant during delayed phase (P = 0.63) (Figure 2). A greater proportion of group A patients achieved CP during both acute as well as delayed phases. Overall, the number of patients experiencing nausea and vomiting was lower in group A. During acute phase, grade 2 nausea as per CTCAE criteria was experienced by 12 patients in group B compared to none of the patients in group A (P < 0.0001) (Table 3). Assessment of nausea severity using the MAT scale revealed significantly lower nausea intensity in the aprepitant group during the acute phase and on key delayed-phase days, particularly Days 3 and 4 (Table 4). The number of patients needing rescue anti-emetic therapy was not significantly different between two groups during acute (1 in group A vs 5 in group B; P value = 0.09) as well as delayed phases (9 in group A vs 14 in group B; P value = 0.23) (Figure 3). Treatment adherence was calculated as per the pill count and patient daily diary entry and was recorded as 92.79% in group A and 94.65% in group B (P value = 0.49). The incidence of reported adverse events was similar in both the groups (Table 5). All the events were mild to moderate in intensity and were managed conservatively; there were no adverse event-related treatment discontinuations.

Figure 2 Comparison of complete response rates achieved in the two antiemetic regimen groups. Acute-phase (0-24 hours), delayed-phase (2^nd-5^th day post concurrent chemoradiotherapy). CR: Complete response.

Figure 3 Comparison of rescue medication use over 5 days post concurrent chemoradiotherapy in both the antiemetic regimen groups. CCRT: Concurrent chemoradiotherapy.

Table 2 Baseline demographic & disease characteristics of the two study groups, n (%)/mean ± SD/median (range).

Characteristics	Group A, n = 43	Group B, n = 43	P value
Age (years)	59.93 ± 9.18	55.12 ± 10.38	0.02
Males	39 (90.7)	38 (88.4)	0.73
BMI (kg/m2)	22.42 ± 1.11	22.84 ± 1.08	0.08
ECOG performance
0	5 (11.62)	6 (13.95)
1	38 (88.4)	37 (86)	0.75
Tumor stage
Stage III	19 (44.19)	17 (39.53)	0.67
Stage IV A	23 (53.49)	24 (55.81)	0.83
Stage IV B	1 (2.33)	2 (4.65)	0.56
Tumor location
Oral cavity	2 (4.65)	8 (18.60)	0.04
Oropharynx	34 (79.07)	26 (60.47)	0.06
Hypopharynx	0 (0.00)	2 (4.65)	0.16
Larynx	7 (16.28)	7 (16.28)	1.00
History of smoking
No. of smokers	42 (97.67)	39 (90.70)	0.17
No. of years of smoking	30 (1-55)	25 (0.5-40)	0.01
No. of bidis smoked	20 (5-40)	20 (2-50)	0.83
No. of hukka smokers	2 (4.65)	0 (0.00)
History of alcohol	34 (79.07)	27 (62.79)	0.1
Presence of comorbidities	9 (20.93)	4 (9.30)	0.1

ECOG: Eastern Cooperative Oncology Group; 0: Fully active, no restrictions; 1: Restricted in strenuous activity, ambulatory; BMI: Body mass index.

Table 3 Secondary efficacy outcomes, n/N (%).

Efficacy parameter	Acute-phase			Delayed-phase
	Group A	Group B	P value	Group A	Group B	P value
Complete protection	42/43 (97.7)	35/43 (81.4)	0.014	33/43 (76.7)	22/43 (51.2)	0.013
Degree of nausea as per CTCAE criteria1
Grade 1	5/43 (11.63)	4/43 (9.30)	0.72	9/43 (20.93)	17/43 (39.53)	0.06
Grade 2	0/43	12/43 (27.90)	0.0001	5/43 (11.63)	11/43 (25.58)	0.09
Degree of vomiting as per CTCAE criteria2
Grade 1	0/43	3/43 (6.8)	0.07	1/43 (2.3)	0/43	0.31
Grade 2	0/43	3/43 (6.8)	0.07	3/43 (6.8)	9/43 (20.9)	0.06

¹Grade 1: Loss of appetite without alteration in eating habits; Grade 2: Oral intake decreased without significant weight loss, dehydration, malnutrition; Grade 3: Inadequate oral caloric or fluid intake; tube feeding; total parenteral nutrition; hospitalization.

²Grade 1: Intervention not indicated; Grade 2: Outpatient IV hydration, medical intervention indicated; Grade 3: Tube feeding, total parenteral nutrition or hospitalization indicated; Grade 4: Life threatening consequences; Grade 5: Death.

Data analysed by Pearson χ² test. CTCAE: Common terminology criteria for adverse events.

Table 4 Degree (intensity) of nausea during acute and delayed-phases in both the groups as per MASSC Antiemesis Tool Scale, mean ± SD.

Phase of emesis	Group A	Group B	P value
Acute- phase	0.65 ± 1.85	2.49 ± 3.37	0.004
Delayed-phase
Day 2	0.76 ± 1.97	1.90 ± 3.00	0.05
Day 3	0.53 ± 1.77	2.30 ± 3.09	0.002
Day 4	0.54 ± 1.75	2.18 ± 3.11	0.004
Day 5	0.90 ± 2.30	1.53 ± 2.74	0.210

Data analysed by the Mann Whitney U test.

Table 5 Adverse events reported in the two study groups, n (%).

Symptoms	Group A	Group B	P value
Reduced appetite	19 (44.1)	28 (65.1)	0.52
Abdominal discomfort	16 (37.2)	17 (39.5)	0.82
Generalized weakness	9 (20.9)	7 (16.2)	0.58
Constipation	8 (18.6)	12 (27.9)	0.31
Headache	6 (13.9)	5 (11.6)	0.75
Diarrhoea	4 (9.3)	7 (16.2)	0.33
Abdominal discomfort with flatulence	3 (6.9)	4 (9.3)	0.69
Dizziness	3 (6.9)	1 (2.3)	0.31
Ghabrahat	0 (0.0)	2 (4.6)	0.15

DISCUSSION

The present study evaluated the efficacy and safety of a NK1RA as an adjunct to ondansetron and dexamethasone, aiming to assess whether intensification of prophylaxis provides superior antiemetic control in the setting of CCRT, where emetogenic stimuli are intensified and conventional regimens may be sub-optimal. Addition of aprepitant to the standard dual regimen (ondansetron and dexamethasone) resulted in a significantly higher acute-phase CR rate (97.7%) compared to standard regimen (81.4%; P = 0.014). Although delayed-phase CR was numerically higher in the aprepitant group, the between-group difference was not statistically significant, and therefore no definitive conclusion regarding delayed-phase complete response can be drawn from the present study. Wang et al[1], in a prospective phase II single-arm trial of triple antiemetic prophylaxis (aprepitant, ondansetron and dexamethasone) in LAHNSCC patients receiving three-weekly high-dose cisplatin, reported an overall CR of 86.0%. The higher CR in our aprepitant arm may partly be explained by the relatively lower emetogenic intensity of weekly cisplatin compared to 3 weekly higher dose cisplatin regimen used by Wang et al[1], rather than solely reflecting superior antiemetic efficacy[28,29]. Another possible reason for this reported difference in CR between two studies may be difference in drug regimens (ondansetron 5 days in our study vs 1 day in the study by Wang et al[1]. Jahn et al[21] reported overall CR rates of 75.9% (aprepitant) vs 60.7% (control) in cycle 1 in a mixed CCRT cohort, with head and neck cancer patients showing even more favourable results (86.4%), a finding consistent with our study. In the GAND emesis trial, a multinational phase 3 randomised controlled trial in cervical cancer patients receiving weekly cisplatin-based CCRT, the addition of fosaprepitant to palonosetron and dexamethasone improved the rate of sustained emesis absence from 48.7% to 65.7%, further providing evidence on superior efficacy of NK1 receptor antagonist-based regimen over standard dual antiemetic regimen[27]. Complete protection — no emesis, no rescue medication, and no more than mild nausea — incorporates nausea control, which patients consistently report as more distressing than vomiting itself. In the present study, both acute-phase (97.7% vs 81.4%; P = 0.014) and delayed-phase CP (76.7% vs 51.2%; P = 0.013) were significantly superior in Group A, suggesting a potential benefit of aprepitant in controlling persistent nausea during the delayed phase. Assessment by the MAT scale confirmed significantly lower nausea intensity in Group A during the acute phase and on Days 3 and 4 of the delayed phase — a temporal pattern consistent with the three-day duration of the aprepitant schedule. CTCAE grading further corroborated these findings: Grade 2 acute nausea was completely absent in Group A vs 27.9% in Group B (P < 0.0001). Although delayed-phase CTCAE differences showed only borderline significance, the consistent trend toward lower nausea grades in group A may be clinically meaningful, although these findings should be interpreted cautiously because statistical significance was not reached— a pattern similarly observed in earlier CCRT studies[1,25-27]. In contrast to Jahn et al[21], who observed progressive worsening of nausea across successive cycles in a heterogeneous tumour population the present study’s homogeneous head and neck cancer cohort over a single well-characterised CCRT cycle demonstrated lower overall nausea burden in both groups. Vomiting severity was limited to Grade 1 and Grade 2 events in both arms, with no Grade 3 or higher episodes — consistent with previously published CCRT antiemetic trials reporting effective prevention of severe vomiting with contemporary regimens. Rescue antiemetic use was consistently lower in Group A during both acute (2.3% vs 11.6%) and delayed phases (20.9% vs 32.6%), though neither difference reached statistical significance. Unlike prior CCRT antiemetic studies — none of which formally evaluated rescue medication use — the present study provides day-wise documentation across the five-day follow-up, enabling a granular temporal assessment of breakthrough emesis. The pattern of rescue use mirrored the nausea intensity data, with Group B showing higher requirements particularly on Days 3 and 4 — the same period during which MAT scores diverged most substantially, lending internal consistency to the findings. The overall adverse event profile was comparable between the two groups, with no statistically significant differences for any reported symptom and no treatment discontinuations in either arm. No new or unexpected adverse reactions were identified, confirming that the addition of aprepitant did not compromise the safety or tolerability of the antiemetic regimen.

Strengths and limitations

To the best of our knowledge, this is the first randomised, double-blind, placebo-controlled trial to evaluate aprepitant specifically in patients with LAHNSCC receiving weekly cisplatin-based CCRT. The double-blind design minimises subject and observer bias — particularly important given the subjective nature of nausea. Separate analysis of acute and delayed phases aligns outcome assessment with the underlying neurochemical mechanisms of CCRT induced nausea and vomiting. Two validated assessment tools (MAT scale and CTCAE) were used in combination, enabling a more comprehensive and reliable evaluation of antiemetic efficacy. Some of the limitations include the single-centre design, which may limit generalisability. Study sample size, although adequate to demonstrate significant differences in primary end point, but is potentially underpowered for certain secondary comparisons such as delayed-phase CR and rescue medication use. Some baseline characteristics including age, tumour location (oral cavity), and duration of smoking were imbalanced between the treatment groups; these variables may potentially influence treatment tolerance and the occurrence of nausea and vomiting during CCRT[30]. Such imbalances may occur by chance due to small sample size, therefore, residual confounding cannot be completely excluded and the findings should be interpreted with this consideration in mind. The study population was restricted to patients receiving weekly cisplatin-based CCRT, and the findings may not be directly applicable to patients receiving alternative chemotherapy regimens or radiotherapy schedules. Study conduct were restricted to single CCRT cycle, leaving cumulative and anticipatory emesis across multiple cycles unevaluated. Assessment of nausea and vomiting relied partly on patient-reported daily diary entries, which may be subject to recall bias despite the use of validated scales. Long-term outcomes such as quality-of-life measures beyond the 5-day observation window were not assessed. A formal pharmacoeconomic evaluation was beyond the scope of the present study. Therefore, although aprepitant demonstrated clinical benefit, the cost-effectiveness and feasibility of its routine incorporation into antiemetic protocols, particularly in public hospitals and resource-limited healthcare settings where ondansetron-based regimens remain the standard of care, could not be evaluated. Future studies incorporating comprehensive cost-effectiveness analyses are warranted to inform healthcare policy and resource allocation.

CONCLUSION

Addition of aprepitant to standard antiemetic prophylaxis significantly improved acute-phase complete response, complete protection, and nausea control in patients receiving weekly cisplatin-based CCRT without compromising safety or tolerability. Although delayed-phase complete response was numerically higher with aprepitant, this difference did not reach statistical significance. Larger adequately powered multicentre studies evaluating multiple CCRT cycles are warranted to confirm these findings.

ACKNOWLEDGEMENTS

We express our gratitude to the patients and the nursing staff in the department of Radiation Oncology at Postgraduate Institute of Medical Sciences, Rohtak.