Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT07184294
Eligibility Criteria:
Inclusion Criteria:
* Participant must be 18 years of age or older at time of consent
* The study is open to all participants regardless of gender, race, or ethnicity
* Participants should have had at least 1 cycle of the chemotherapy regimen at the time of recruitment
* Participant must have a baseline anxiety score \> 3 on the Visual Analog scale (VAS)
* Scheduled for at least six more infusion sessions
* Participant has had complete blood count (CBC) lab work completed in the past 24 hours
Exclusion Criteria:
* Platelet count less than 20,000. Patients taking anticoagulants are not excluded, as the protocol for massage in infusion ensures that deep pressure massage is never performed, and patient's massage will not exceed a 3 on the Walton scale
* Absolute neutrophil count (ANC) less than 500
* Patient has received radiation therapy to any of the targeted areas within the past 90 days
* Any patient that is currently using a cold therapy device that would interfere with their ability to have a massage without removing the device (cold gloves, cold socks)
* Had surgery on their foot, leg, head, neck, shoulder, hands, or arms within the past three months
* Participant has rashes, open wounds, or any skin conditions that could be exacerbated by massage
* Known allergies to creams, lotions, or any other substances that may be used during the massage therapy sessions
* Ongoing uncontrolled active psychiatric condition that would interfere in the conduct of the study (e.g., mood disorders, anxiety, psychosis disorders, or substance use), as determined by the patient's primary cancer team
* Participants with a known allergy to Bioton dual-purpose massage cream or any of its ingredients will be excluded from the study
* In order to minimize undue influence and coercion, the study team will not personally solicit an employee for participation: An employee who is under the direct/indirect supervision of the principal investigator (PI)/a co-investigator/the study manager and a direct study team member
* Pregnancy
* Any participants with bone metastasis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07184294
Study Brief:
Protocol Section:
NCT07184294