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Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Oxaliplatin

ABSTRACT: RATIONALE: Learning how often patients experience nausea and vomiting after receiving anti-vomiting medicine and chemotherapy for colorectal cancer may help doctors plan better treatment and improve patients’ quality of life. PURPOSE: This clinical trial is studying delayed nausea and vomiting in patients with colorectal cancer receiving standard anti-vomiting medicine during the first course of chemotherapy.

DISEASE(S): Vomiting,Nausea And Vomiting,Colon Cancer,Colorectal Cancer,Colorectal Neoplasms,Nausea

PROVIDER: 2059306 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Background: Nausea and vomiting (emesis) is a common and burdensome side-effect of emetogenic chemotherapy. Emesis affects both the patient’s quality of life and induces high costs within the health-care system. Many patients are interested in acupuncture, despite weak scrientific evidence for its effects beside non-specific effects. Few credibly sham-controlled studies have previously been conducted. The therapist’s care and communication during acupuncture as well as during standard care may induce non-specific effects, such as placebo effects, potentially driven by the patient’s expectations. It is not known if the type of communication, in terms of how positive the therapist communicates regarding expected effects, affects the effect of antiemetic treatments. Aims: To investigate if chemotherapy-induced emesis, treatment expectancy and quality of life differ between patients who receive A) standard care including antiemetics, B) standard care plus sham acupuncture or C) standard treatment plus genuine acupuncture by a therapist who emphasizes the positive expected outcomes of the treatment, compared to a therapist who communicates neutral regarding the expected outcomes. Procedure: The eligible patients will be randomized to A) standard care, including antiemetics or to B) standard treatment plus sham acupuncture or C) standard treatment plus genuine acupuncture. Within the three groups, the patients are randomized to receive either neutral or positive communication with the therapist during the treatment. Outcome measures: The primary outcome is intensity of nausea within the five days after the chemotherapy session in patients receiving positive or neutral communication. Data collection of nausea and vomiting, expectations, and quality of life is performed at baseline the day before the studied chemotherapy session, during 10 days after the studied chemotherapy session, and at a follow-up ten days after the last chemotherapy session.

Dataset Information

Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Oxaliplatin

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