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| Name | Class |
|---|---|
| Falu Hospital | OTHER |
| University of Gavle | OTHER |
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Background: Chemotherapy-induced nausea and vomiting (CINV) is a common and burdensome side-effect of emetogenic chemotherapy. CINV 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 CINV, 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 antiemetic treatment or to B) standard antiemetic treatment plus sham acupuncture or C) standard antiemetic treatment plus genuine acupuncture. Within the three groups, the patients are randomized to receive either neutral or positive communication from 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.
Background: Chemotherapy-induced nausea and vomiting (CINV) is a common and burdensome side-effect of emetogenic chemotherapy. CINV 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 antiemetic treatment 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 CINV, treatment expectancy and quality of life differ between patients who receive A) standard antiemetic treatment, B) standard antiemetic treatment plus sham acupuncture or C) standard antiemetic 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: Patients undergoing chemotherapy for cancer at three Swedish oncology departments will receive written and oral study information and are screened for study criteria. The eligible patients will be randomized to A) standard antiemetic treatment or to B) standard antiemetic treatment plus sham acupuncture or C) standard antiemetic treatment plus genuine acupuncture. Within the three groups, the patients are randomized to receive either neutral or positive communication from 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.
Qualitative interviews regarding the patients' experiences of the communication with the professionals are conducted with a strategicaly selected group of patients from all randomization combinations. The selection aims to provide heterogenicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care (A) | Other | Standard antiemetic treatment (A) with neutral communication (A1) or positive communication (A2) |
|
| Sham acupuncture (B) | Placebo Comparator | Standard antiemetic treatment plus Sham acupuncture (B) with neutral communication (B1) or positive communication (B2) |
|
| Genuine acupuncture (C) | Experimental | Standard antiemetic treatment plus Genuine acupuncture (C) with neutral communication (C1) or positive communication (C2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard care | Other | A) Standard antiemetic treatment means receiving ordinary antiemetic medications. Within the group, the patients will be randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected antiemetic effects of their treatment, using a standardized communication model. |
| Measure | Description | Time Frame |
|---|---|---|
| Average nausea intensity day 1-5 (the day of the current chemotherapy session and the four following days). | Visual Analogue Scale (VAS). | In the morning of day 1-5 (the day of chemotherapy and the four following days). |
| Measure | Description | Time Frame |
|---|---|---|
| The patient´s treatment expectations | Visual analogue scale (VAS) | Every morning day 1-10 (the day of the current chemotherapy session and the 10 following days). |
| Level of well-being | Visual analogue scale (VAS) |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-analyzes. | Costs per patient, in relation to emesis outcomes and in relation to quality of life. | Emesis outcomes are measured every morning day 1-10 (the day of the current chemotherapy session and the 10 following days). |
| Cortisol concentration |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna E Efverman, PhD | University of Gavle | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sundsvall Hospital | Sundsvall | SE-85186 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40970276 | Derived | Sara L F, Ylva W, Marit S, Anna E. The Significance of Communication and Treatment Expectations in Cancer Care: An Interview Study With Cancer Care Practitioners. Integr Cancer Ther. 2025 Jan-Dec;24:15347354251370781. doi: 10.1177/15347354251370781. Epub 2025 Sep 19. | |
| 40844814 | Derived | Ylva W, Per F, Erling E, Anna E. Design of a Randomized Sham-Controlled Trial: Strengthening Positive Treatment Expectations Using a Communication Model for Maximized Antiemetic Effects of Acupuncture and Antiemetics During Emetogenic Neo-/Adjuvant Chemotherapy. Integr Cancer Ther. 2025 Jan-Dec;24:15347354251361464. doi: 10.1177/15347354251361464. Epub 2025 Aug 22. |
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All other care providers beside the acupuncture/sham providing therapists are blinded to randomization group. For example, care providers providing the standard antiemetic treatment and the chemotherapy per se are blinded regarding randomization group.
|
| Sham acupuncture | Device | B) Sham acupuncture is administered bilaterally to a non-acupuncture point two body-inches proximal and one body-inch radial from PC6 using the telescopic Park Sham Device. The sham-needle is blunt and glides upward into its handle instead of penetrating. Marking tubes hold the needle in place. The therapist gives an illusion of manipulating the needle by turning it three times until it touches the skin, but no specific needle sensation ("deqi") will occur. Within the group, the patients will be randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected antiemetic effects of their treatment, using a standardized communication model. |
|
| Genuine acupuncture | Device | C) Acupuncture will be administered bilaterally to the standard antiemetic point PC6 located two body-inches proximal of the wrist crease, between the tendons of palmaris longus and flexor carpi radialis. Sharp acupuncture needles will be inserted into a depth of a half body-inch. The needles will be manipulated three times (at the start, middle and end of the treatment session) by twirling and lifting until deqi occurres. Within the group, the patients will be randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected antiemetic effects of their treatment, using a standardized communication model. |
|
| Four times: The day before the current chemotherapy session, 5 and 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session. |
| Level of well-being | EQ-5D | Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session. |
| Level of well-being | FACT-G | Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session. |
| Level of activity | Verbal category scales | Four times: The day before the current chemotherapy session, 5 and 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session. |
| Quality of life | Visual analogue scale (VAS) | Four times: The day before the current chemotherapy session, 5 and10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session. |
| Quality of life | EQ-5D | Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session. |
| Quality of life | FACT-G | Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session. |
| Impact of nausea on daily activities | Visual analogue scale (VAS) | Two times: 5 and 10 days after the current chemotherapy session. |
Saliva sample
| Two times: directly before and after the acupuncture or control intervention. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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