Chemotherapy-induced Nausea and VomitingNCT00086762
Mindfulness Relaxation Compared With Relaxing Music and Standard Symptom Management Education in Treating Patients Who Are Undergoing Chemotherapy For Newly Diagnosed Solid Tumors
A study testing MR Therapy, Relaxing Music (RM) Therapy and Standard Symptom Management in people with Chemotherapy-induced Nausea and Vomiting and Unspecified Adult Solid Tumor, Protocol Specific, run by M.D. Anderson Cancer Center at 9 sites in United States.
Trial summary
RATIONALE: Mindfulness relaxation, a technique to help patients quiet their thoughts and relax their bodies before and during chemotherapy, may reduce or prevent nausea and vomiting. It may also help improve mental health, quality of life, and immune function in patients receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific, Breast Cancer
- What is being tested?
- MR Therapy, Relaxing Music (RM) Therapy and Standard Symptom Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 9 sitesUnited States
- Study dates
- Jun 2004to 11 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are >/= 18 years of age
- are anticipated to undergo at least four cycles of chemotherapy treatment
- have had no previous treatment with chemotherapy
- have no evidence of distant metastatic disease
- can read/speak in English or Spanish
- have no known psychotic diagnosis
- have an expected survival of at least 6 months
Who cannot join
- have a known psychotic diagnosis
- will undergo an undefined number of chemotherapy regimens
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
CCOP - Greenville
Greenville, South Carolina, 29615
University of Texas M.D. Anderson CCOP Research Base
Houston, Texas, 77030-4009
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
CCOP - Scott and White Hospital
Temple, Texas, 76508
CCOP - Wichita
Wichita, Kansas, 67214-3882
CCOP - Main Line Health
Wynnewood, Pennsylvania, 19096
About this study
Official title: Chemotherapy and Mindfulness Relaxation: A Randomized Trial at M.D. Anderson Cancer Center and M.D. Anderson Community Clinical Oncology Program
RATIONALE: Mindfulness relaxation, a technique to help patients quiet their thoughts and relax their bodies before and during chemotherapy, may reduce or prevent nausea and vomiting. It may also help improve mental health, quality of life, and immune function in patients receiving chemotherapy.
PURPOSE: This randomized clinical trial is studying mindfulness relaxation to see how well it works compared to relaxing music or standard symptom management education in treating patients who are receiving chemotherapy for newly diagnosed solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- Compare the effect of mindfulness relaxation vs relaxing music vs standard symptom management education on conditioned and nonconditioned nausea and vomiting in patients with newly diagnosed solid tumors undergoing chemotherapy.
Secondary
- Compare mental health (anxiety, depression, and distress), quality of life (cancer-related symptoms, fatigue, sleep, and pain), and immune function in patients receiving these interventions.
OUTLINE: This is a multicenter study comprising a pilot phase followed by a randomized phase. (Pilot phase completed as of 3/10/2012.)
- Pilot phase: Patients undergo mindfulness relaxation (MR) therapy comprising listening to instructions on breathing techniques and other mind and body relaxation practices on compact disc for 30 minutes before and during each chemotherapy session AND at least once daily for the entire duration of chemotherapy treatment. (Pilot phase completed as of 3/10/2012.)
- Randomized phase: Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients undergo MR therapy as in the pilot phase.
- Arm II: Patients listen to relaxing music (with no instructions on relaxation techniques) for 30 minutes before and during each chemotherapy session AND at least once daily for the entire duration of chemotherapy treatment.
- Arm III: Patients receive standard symptom management education. In both phases, nausea and vomiting, mental health (anxiety, depression, and distress), and quality of life (cancer-related symptoms, fatigue, sleep, and pain) are assessed at baseline, periodically during treatment, and then at 3 months.
Patients are followed annually for up to 5 years for survival.
PROJECTED ACCRUAL: A total of 474 patients will be accrued for this study.
- Conditions
- Chemotherapy-induced Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific, Breast Cancer, Gastrointestinal Cancer, Disease (or Disorder); Gynecological, Prostate Cancer
- Being tested
- MR Therapy, Relaxing Music (RM) Therapy, Standard Symptom Management, Questionnaires
- Keywords
- nausea and vomiting, unspecified adult solid tumor, protocol specific, mindfulness relaxation
- Medical subject headings
- Vomiting, Breast Neoplasms, Gastrointestinal Neoplasms, Disease, Prostatic Neoplasms, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR TherapyBehavioural
Arm I: Participants receive Mindfulness Relaxation (MR) therapy as in the pilot phase. Instructions given on breathing techniques and other practices to help relax mind and body.
Relaxing Music (RM) TherapyBehavioural
Participants listen to relaxing music (with no instructions on relaxation techniques) for 30 minutes before and during each chemotherapy session AND at least once daily for the entire duration of chemotherapy treatment
Standard Symptom ManagementBehavioural
Participants receive standard symptom management education. General information received about how to manage symptoms that develop due to the chemotherapy.
QuestionnairesBehavioural
Also called surveys
Questionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion.
| Study group | Role | What they receive |
|---|---|---|
| MR Therapy | Experimental | Participants receive Mindfulness Relaxation (MR) therapy as in the pilot phase. A CD with the mindfulness relaxation technique recorded on it will be given to participant. Participant to listen to the recording for about 30 minutes before receiving chemotherapy and during the time they are receiving chemotherapy. In addition to the mindfulness relaxation technique, they will also receive general information about how to manage symptoms that develop due to the chemotherapy they are receiving. Receives: Behavioral: MR Therapy; Behavioral: Questionnaires |
| Relaxing Music (RM) Therapy | Experimental | Arm II: Participants listen to relaxing music (with no instructions on relaxation techniques) for 30 minutes before and during each chemotherapy session AND at least once daily for the entire duration of chemotherapy treatment. Receives: Behavioral: Relaxing Music (RM) Therapy; Behavioral: Questionnaires |
| Standard Symptom Management | Active comparator | Arm III: Participants receive standard symptom management education. Receives: Behavioral: Standard Symptom Management; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conditioned nausea and vomiting as measured by Morrow assessment of nausea and emesis (MANE)
Number of incidents conditioned nausea and vomiting as measured by MANE at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Measured: Up to 12 months post treatment
Distress as measured by Impact of Event Scale (IES)
Distress as measured by Impact of Event Scale (IES) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Measured: Up to 12 months post treatment
Fatigue as measured by brief fatigue inventory (BFI)
Fatigue as measured by brief fatigue inventory (BFI) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Measured: Up to 12 months post treatment
Anxiety as measured by Spielberger State/Trait Anxiety Scale (STAI)
Anxiety as measured by Spielberger State/Trait Anxiety Scale (STAI) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Measured: Up to 12 months post treatment
Depression as measured by Center for Epidemiology-Depression (CES-D)
Depression as measured by Center for Epidemiology-Depression (CES-D) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment.
Measured: Up to 12 months post treatment
Sleep as measured by Pittsburgh Sleep Quality Index (PSQI)
Sleep as measured by Pittsburgh Sleep Quality Index (PSQI) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Measured: Up to 12 months post treatment
Pain as measured by brief pain inventory (BPI)
Pain as measured by brief pain inventory (BPI) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Measured: Up to 12 months post treatment
Quality of life as measured by Functional Assessment of Cancer Therapy
Quality of life as measured by Functional Assessment of Cancer Therapy at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Measured: Up to 12 months post treatment
Secondary outcomes (1)
Immune suppression as measured by cytotoxicity, stimulated release of IL-12, -4, -10, intracellular cytokines and lymphocyte phenotype
Immune suppression as measured by cytotoxicity, stimulated release of IL-12, -4, -10, intracellular cytokines and lymphocyte phenotype at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Measured: Up to 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2004 (estimated)
- Study startJun 2004
- Primary completion11 Aug 2022
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 474 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jon Hunter, MD, FRCP, Principal investigator, Mount Sinai Hospital, CanadaLorenzo Cohen, PHD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086762
- Sponsor's protocol ID
- 2004-0024
- Other IDs
- MDA-CCC-0106, CDR0000357213, NCI-2009-00860
- Status last verified
- Aug 2022
- First submitted
- 8 Jul 2004
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy and Mindfulness Relaxation: A Randomized Trial at M.D. Anderson Cancer Center and M.D. Anderson Community Clinical Oncology Program
- ClinicalTrials.gov ID
- NCT00086762
- Acronym / sponsor ID
- 2004-0024
- Conditions
- Chemotherapy-induced Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific, Breast Cancer, Gastrointestinal Cancer, Disease (or Disorder); Gynecological, Prostate Cancer
- Keywords
- nausea and vomiting, unspecified adult solid tumor, protocol specific, mindfulness relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 474 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2004 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 12 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Mindfulness relaxation, a technique to help patients quiet their thoughts and relax their bodies before and during chemotherapy, may reduce or prevent nausea and vomiting. It may also help improve mental health, quality of life, and immune function in patients receiving chemotherapy.
PURPOSE: This randomized clinical trial is studying mindfulness relaxation to see how well it works compared to relaxing music or standard symptom management education in treating patients who are receiving chemotherapy for newly diagnosed solid tumors.
Detailed description
OBJECTIVES:
Primary
- Compare the effect of mindfulness relaxation vs relaxing music vs standard symptom management education on conditioned and nonconditioned nausea and vomiting in patients with newly diagnosed solid tumors undergoing chemotherapy.
Secondary
- Compare mental health (anxiety, depression, and distress), quality of life (cancer-related symptoms, fatigue, sleep, and pain), and immune function in patients receiving these interventions.
OUTLINE: This is a multicenter study comprising a pilot phase followed by a randomized phase. (Pilot phase completed as of 3/10/2012.)
- Pilot phase: Patients undergo mindfulness relaxation (MR) therapy comprising listening to instructions on breathing techniques and other mind and body relaxation practices on compact disc for 30 minutes before and during each chemotherapy session AND at least once daily for the entire duration of chemotherapy treatment. (Pilot phase completed as of 3/10/2012.)
- Randomized phase: Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients undergo MR therapy as in the pilot phase.
- Arm II: Patients listen to relaxing music (with no instructions on relaxation techniques) for 30 minutes before and during each chemotherapy session AND at least once daily for the entire duration of chemotherapy treatment.
- Arm III: Patients receive standard symptom management education. In both phases, nausea and vomiting, mental health (anxiety, depression, and distress), and quality of life (cancer-related symptoms, fatigue, sleep, and pain) are assessed at baseline, periodically during treatment, and then at 3 months.
Patients are followed annually for up to 5 years for survival.
PROJECTED ACCRUAL: A total of 474 patients will be accrued for this study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MR Therapy | Experimental | Behavioral: MR Therapy, Behavioral: QuestionnairesParticipants receive Mindfulness Relaxation (MR) therapy as in the pilot phase. A CD with the mindfulness relaxation technique recorded on it will be given to participant. Participant to listen to the recording for about 30 minutes before receiving chemotherapy and during the time they are receiving chemotherapy. In addition to the mindfulness relaxation technique, they will also receive general information about how to manage symptoms that develop due to the chemotherapy they are receiving. |
| Relaxing Music (RM) Therapy | Experimental | Behavioral: Relaxing Music (RM) Therapy, Behavioral: QuestionnairesArm II: Participants listen to relaxing music (with no instructions on relaxation techniques) for 30 minutes before and during each chemotherapy session AND at least once daily for the entire duration of chemotherapy treatment. |
| Standard Symptom Management | Active comparator | Behavioral: Standard Symptom Management, Behavioral: QuestionnairesArm III: Participants receive standard symptom management education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- are >/= 18 years of age
- are anticipated to undergo at least four cycles of chemotherapy treatment
- have had no previous treatment with chemotherapy
- have no evidence of distant metastatic disease
- can read/speak in English or Spanish
Key exclusion criteria (2 listed)
- have a known psychotic diagnosis
- will undergo an undefined number of chemotherapy regimens
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR TherapyArm I: Participants receive Mindfulness Relaxation (MR) therapy as in the pilot phase. Instructions given on breathing techniques and other practices to help relax mind and body. | Behavioural | MR Therapy |
| Relaxing Music (RM) TherapyParticipants listen to relaxing music (with no instructions on relaxation techniques) for 30 minutes before and during each chemotherapy session AND at least once daily for the entire duration of chemotherapy treatment | Behavioural | Relaxing Music (RM) Therapy |
| Standard Symptom ManagementParticipants receive standard symptom management education. General information received about how to manage symptoms that develop due to the chemotherapy. | Behavioural | Standard Symptom Management |
| QuestionnairesAlso: surveysQuestionnaire completion at baseline, during the middle of chemotherapy treatment, and at chemotherapy completion. | Behavioural | MR Therapy, Relaxing Music (RM) Therapy, Standard Symptom Management |
Primary outcome
Conditioned nausea and vomiting as measured by Morrow assessment of nausea and emesis (MANE)
Time frame: Up to 12 months post treatment
Number of incidents conditioned nausea and vomiting as measured by MANE at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Distress as measured by Impact of Event Scale (IES)
Time frame: Up to 12 months post treatment
Distress as measured by Impact of Event Scale (IES) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Fatigue as measured by brief fatigue inventory (BFI)
Time frame: Up to 12 months post treatment
Fatigue as measured by brief fatigue inventory (BFI) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Anxiety as measured by Spielberger State/Trait Anxiety Scale (STAI)
Time frame: Up to 12 months post treatment
Anxiety as measured by Spielberger State/Trait Anxiety Scale (STAI) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Depression as measured by Center for Epidemiology-Depression (CES-D)
Time frame: Up to 12 months post treatment
Depression as measured by Center for Epidemiology-Depression (CES-D) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment.
Sleep as measured by Pittsburgh Sleep Quality Index (PSQI)
Time frame: Up to 12 months post treatment
Sleep as measured by Pittsburgh Sleep Quality Index (PSQI) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Pain as measured by brief pain inventory (BPI)
Time frame: Up to 12 months post treatment
Pain as measured by brief pain inventory (BPI) at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
Quality of life as measured by Functional Assessment of Cancer Therapy
Time frame: Up to 12 months post treatment
Quality of life as measured by Functional Assessment of Cancer Therapy at baseline, after course 2 or 3, at end of treatment, and then 6 and 12 months after completion of study treatment
1 secondary outcome
Immune suppression as measured by cytotoxicity, stimulated release of IL-12, -4, -10, intracellular cytokines and lymphocyte phenotype
Time frame: Up to 12 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Hunter, MD, FRCP principal investigator
Mount Sinai Hospital, Canada
Lorenzo Cohen, PHD study chair
M.D. Anderson Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR Therapy, Relaxing Music (RM) Therapy and Standard Symptom Management in people with Chemotherapy-induced Nausea and Vomiting and Unspecified Adult Solid Tumor, Protocol Specific, run by M.D. Anderson Cancer Center at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conditioned nausea and vomiting as measured by Morrow assessment of nausea and emesis (MANE) (time frame: Up to 12 months post treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.