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The Effects of Acupuncture and the Therapist´s Communication on Chemotherapy Induced Nausea and Vomiting

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ClinicalTrials.gov Identifier: NCT03232541
Recruitment Status : Recruiting
First Posted : July 28, 2017
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
Linkoeping University
Västervik Hospital
Falun Hospital
Information provided by (Responsible Party):
Ylva Widgren, Västernorrland County Council, Sweden

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Bladder Cancer Testicular Cancer Prostate Cancer Chemotherapy-induced Nausea and Vomiting Other: Standard care Device: Sham acupuncture Device: Genuine acupuncture Not Applicable

Detailed 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: 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 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.

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: All other care providers beside the acupuncture/sham providing therapists are blinded to randomization group. For example, care providers providing the standard care antiemetic treatment and the chemotherapy per se are blinded for randomization group.
Primary Purpose: Supportive Care
Official Title: The Effects of Acupuncture and the Therapist´s Communication on Chemotherapy Induced Nausea and Vomiting: a Randomized, Sham-controlled Trial
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Standard care (A)
Standard care (A) with neutral communication (A1) or positive communication (A2)
Other: Standard care
A) Ordinary nausea 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.

Placebo Comparator: Sham acupuncture (B)
Standard nausea treatment plus Sham acupuncture (B) with neutral communication (B1) or positive communication (B2)
Device: Sham acupuncture
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.

Experimental: Genuine acupuncture (C)
Standard nausea treatment plus Genuine acupuncture (C) with neutral communication (C1) or positive communication (C2)
Device: Genuine acupuncture
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.




Primary Outcome Measures :
  1. Average nausea intensity day 1-5 (the day of the current chemotherapy session and the four following days). [ Time Frame: In the morning of day 1-5 (the day of chemotherapy and the four following days). ]
    Visual Analogue Scale (VAS).


Secondary Outcome Measures :
  1. The patient´s treatment expectations [ Time Frame: Every morning day 1-10 (the day of the current chemotherapy session and the 10 following days). ]
    Visual analogue scale (VAS)

  2. Level of well-being [ Time Frame: 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. ]
    VAS

  3. Level of well-being [ Time Frame: 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. ]
    Verbal category scales

  4. Level of well-being [ Time Frame: 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. ]
    EQ-5D

  5. Level of well-being [ Time Frame: 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. ]
    FACT-G

  6. Level of activity [ Time Frame: 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. ]
    VAS

  7. Level of activity [ Time Frame: 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. ]
    Verbal category scales

  8. Level of activity [ Time Frame: 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. ]
    EQ-5D

  9. Level of activity [ Time Frame: 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. ]
    FACT-G

  10. Quality of life [ Time Frame: 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. ]
    VAS

  11. Quality of life [ Time Frame: 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. ]
    Verbal category scales

  12. Quality of life [ Time Frame: 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. ]
    EQ-5D

  13. Quality of life [ Time Frame: 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. ]
    FACT-G


Other Outcome Measures:
  1. Cost-analyzes. [ Time Frame: Emesis outcomes are measured every morning day 1-10 (the day of the current chemotherapy session and the 10 following days). ]
    Costs per patient, in relation to emesis outcomes and in relation to quality of life.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of at least 18 years of age
  • Breast, colorectal, bladder, testicular or prostate cancer
  • Receiving adjuvant or neo-adjuvant intravenous chemotherapy inducing medium or high risk for emesis
  • Willing and capable to give their informed consent and to take part of the treatment and data collection procedure

Exclusion Criteria:

  • Consumption of antiemetics or experiences of persistent nausea, which will persist within 24 hours prior to the start of the chemotherapy session
  • Hemophilia
  • Former participation in the same study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03232541


Contacts
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Contact: Ylva Widgren, MSP +46 70 089 68 71 ylva.widgren@liu.se
Contact: Anna E Enblom, PhD +46 70 089 51 49 anna.enblom@liu.se

Locations
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Sweden
Sundsvall Hospital Recruiting
Sundsvall, Sweden, SE-85186
Contact: Ylva Widgren       ylva.widgren@liu.se   
Sponsors and Collaborators
Västernorrland County Council, Sweden
Linkoeping University
Västervik Hospital
Falun Hospital
Investigators
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Principal Investigator: Anna E Enblom, PhD Linkoeping University

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Responsible Party: Ylva Widgren, Study coordinator, Västernorrland County Council, Sweden
ClinicalTrials.gov Identifier: NCT03232541     History of Changes
Other Study ID Numbers: Emesis 001
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Nausea
Vomiting
Colorectal Neoplasms
Urinary Bladder Neoplasms
Testicular Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Endocrine Gland Neoplasms
Genital Neoplasms, Male
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders