Neoplasms

All Conditions

Symptoms and General Pathology

Head and Neck Neoplasms

Nausea

Vomiting

Signs and Symptoms, Digestive

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dermatologic Agents

Dexamethasone

Ondansetron

Aprepitant

Cisplatin

Dexamethasone acetate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Serotonin

Serotonin 5-HT3 Receptor Antagonists

Neurotransmitter Agents

Neurokinin-1 Receptor Antagonists

Substance P

Neurokinin A

Aprepitant combined with ondansetron and dexamethasone

Intensity-modulated radiotherapy was given to the patients with regimen of 69.96 Gy-73.92 Gy to the gross target volume of nasopharynx,69.96 Gy to the gross target volume of positive nodes, 60.06 Gy the high risk clinical target volume, 50.96 Gy to the low risk clinical target volume. Concurrent chemotherapy is administrated with cisplatin 100mg/m2 at d1, d22, d43 during radiotherapy. Patients receive concurrent aprepitant 125mg, dexamethasone 12mg, and ondansetron 8mg p.o. on day1. AND then patients received aprepitant 80mg, dexamethasone 8mg on day 2-5 at every chemotherapy cycle.

Junlin Yi, M.D.

To evaluate the safety and efficacy of aprepitant combined with ondansetron and dexamethasone to prevent nausea and vomiting induced by Intensity-modulated Radiotherapy (IMRT) cisplatin-chemotherapy regimen in locally advanced squamous cell carcinoma of head and neck

To evaluate the complete response rate, nause-free rate, vomiting-free rate, and the quality of life of aprepitant combined with ondansetron and dexamethasone for the nausea and vomiting induced by chemoradiotherapy in HNSCC.

Aprepitant for Nause and Vomiting Induced by Chemoradiotherapy in HNSCC

A Prospective, Open-label, Single-arm Study for Efficacy and Safety of Three-drug Antiemetic Regimen to Prevent the Emesis During Radiotherapy With Concurrent Chemoradiotherapy in Locally Advanced HNSCC

no vomiting and nausea, and no use of rescue therapy

Quality of life questionnaire core 30 chinese version is used. The total score is reported, and the high values represent a worse outcome.

Chinese Academy of Medical Sciences

Vice director of department of radiation oncology

Nervous System Diseases

Cancer Pain

Pain

Neurologic Manifestations

Pharmaceutical Solutions

Analgesics

Psychotropic Drugs

Dronabinol

Hallucinogens

Analgesics, Non-Narcotic

Drug: Dronabinol (SYNDROS) Oral solution of SYNDROS (5 mg/mL)

Drug: THC:CBG Oral solution of THC (5 mg/mL) \& CBG (5 mg/mL)

Drug: THC:CBC Oral solution of THC (5 mg/mL) \& CBC (5 mg/mL)

Assessment of Pharmacokinetic and pharmacodynamic profile of THC oral formulations in 4 arms in healthy volunteers and patients post-chemotherapy.

Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator

Aura L Pinzon Galvis, PharmB

Andres Turizo Smith, PharmB

Carlos Rodriguez Martinez, M.D.

Study based on the pharmacokinetic, pharmacodynamic, safety and stability evaluation of 3 standardized formulations of THC, to be used in healthy volunteers and post-chemotherapy patients as an adjuvant in the symptomatic treatment of the latter in discomfort associated with cancer treatment, with the aim of possible new therapeutic entities.

This evaluation project of 3 oral formulations of Δ9-THC will be carried out in two phases: Phase I evaluation of bioequivalences in healthy subjects and Phase II evaluation of safety and effectiveness comparing with the reference product (Dronabinol 5mg/mL), formulations derived from cannabis for the management of nausea, vomiting post chemotherapy and exploratory in cancer pain.

Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC

Pharmacokinetic and Pharmacodynamic Evaluation of 3 Standard Formulations of Δ9-THC in Healthy Volunteers and Post-chemotherapy Patients in Colombia

Pharmacokinetics of THC by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf)) \[ Time Frame: 0 hours (pre-dose), as well as at 0.12, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose \]

Brief pain inventory (BPI); The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. The questions ask participants to rate their pain in the prior 24-hours OR prior 7-day on a 0 to 10 Numerical Rating Scale (NRS), where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine."

Drug Effects Questionnaire (DEQ);is used in studies of acute subjective response (SR) to a variety of substances. The DEQ consists of 11 questions: "Feel Drug", "Feel High", "Like Drug", and "Want More", "dislike the sensation", "any sensations", "feel a head rush", "like drug effect", "dislike any effects". To calculate the DEQ- 'Good Drug Effects'. Each question was measured on a scale with a minimum score of 0 and a maximum score of 100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome

To investigate THC oral formulations in terms of the proportion of patients with no significant nausea (none or mild nausea) following initiation of oral formulations of THC (dronabinol) in post-chemotherapy patients

Evaluate the Safety and Tolerability of Oral Formulations of THC, Number of AEs during 14 days for healthy subjects and 20 days for post-chemotherapy patients vs active drug phase vs. Dronabinol active comparator

EORTC quality of life questionnaire (QLQ) is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials.

Self-reported symptoms related to treatment. Each item is rated on a response scale 1 = not at all to 4 = very much and refer to the time frame "during the last days" EORTC QLQ-C30

LaSanta S A S

Digestive System Diseases

Neoplasm Metastasis

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Fosaprepitant

Folfirinox

Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy.

fosaprepitant dimeglumine

Philip A. Philip, M.D., Ph.D., F.R.C.P

This clinical trial studies fosaprepitant dimeglumine in preventing nausea and vomiting in patients with gastrointestinal cancer receiving combination chemotherapy. Antiemetic drugs, such as fosaprepitant dimeglumine, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy.

PRIMARY OBJECTIVES:

I. To evaluate efficacy of the addition of fosaprepitant (fosaprepitant dimeglumine) in controlling acute and delayed vomiting with the standard prophylactic anti-emetic combination of 5-HT3 receptor antagonist and dexamethasone for gastrointestinal cancer patients receiving FOLFIRINOX (5-FU \[fluorouracil\], oxaliplatin and irinotecan \[irinotecan hydrochloride\]) chemotherapy.

II. To determine the rate of complete response (no emetic episode and no rescue medication) in the combined acute and delayed phase from 0-120 hours after chemotherapy.

SECONDARY OBJECTIVES:

I. To determine the incidence of nausea and vomiting in both acute (\< 24 hours) and delayed (24- 120 hours) setting in patients receiving FOLFIRINOX chemotherapy.

TERTIARY OBJECTIVES:

I. Follow overall survival in patients receiving FOLFIRINOX chemotherapy.

OUTLINE:

Patients receive fosaprepitant dimeglumine intravenously (IV) 30 minutes prior to FOLFIRINOX chemotherapy.

After completion of study treatment, patients are followed up for 2 months.

Fosaprepitant Dimeglumine in Preventing Nausea and Vomiting in Patients With Gastrointestinal Cancer Receiving Combination Chemotherapy

Prevention of Nausea and Vomiting Secondary to FOLFIRINOX Chemotherapy in Gastrointestinal Cancer Patients

Achieved if a patient has no episodes of vomiting and requires no rescue medication during the first 120 hours after fosaprepitant dimeglumine administration.

Achieved if a patient has no episodes of vomiting at both 24 and 120 hours after fosaprepitant dimeglumine administration.

Achieved if a patient has no episodes of nausea at both 24 and 120 hours after fosaprepitant dimeglumine administration.

National Cancer Institute (NCI)

Philip Philip

Principal Investigator

All Participants

Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy.

fosaprepitant dimeglumine: Given IV

Treatment (Nausea and Vomiting Prophylaxis)

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

30 patients were eligible and consented to this protocol. 3 of these patients never began treatment, leaving our final analysis number at 27.

Dr. Philip A. Philip, M.D., Ph.D., F.R.C.P

The analysis set includes patients (n=26) who returned an outcomes diary at 24 or 120 hours post treatment. 1 patient could not be evaluated as they did not return their diary.

Percentage of Participants With Control of Vomiting and Rescue Medication Control

Percentage of Participants With Control of Both Acute and Delayed Vomiting

The analysis set includes patients (n=25) who returned an outcomes diary at 24 or 120 hours post treatment with nausea information filled out. 2 patients could not be evaluated as they did not return their diary with nausea information filled out.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Aprepitant for Nause and Vomiting Induced by Chemoradiotherapy in HNSCC	NCT03572829	Vomiting Nausea Post Che... Head Neck Cance...	Aprepitant	18 Years - 80 Years	ChineseAMS
Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC	NCT05272865	Nausea Post Che... Vomiting Cancer Pain Cancer Related ... Neoplasms	Pharmacokinetic...	18 Years -	LaSanta S A S
Aprepitant for Nause and Vomiting Induced by Chemoradiotherapy in HNSCC	NCT03572829	Vomiting Nausea Post Che... Head Neck Cance...	Aprepitant	18 Years - 80 Years	ChineseAMS
Fosaprepitant Dimeglumine in Preventing Nausea and Vomiting in Patients With Gastrointestinal Cancer Receiving Combination Chemotherapy	NCT01504711	Gastrointestina... Nausea Post Che...	fosaprepitant d...	19 Years -	Barbara Ann Karmanos Cancer Institute

Spots Global Cancer Trial Database for nausea post chemotherapy