Different types of massage to reduce anxiety during chemotherapy infusion
Assessing the Feasibility of Different Types of Massage to Reduce Anxiety During Chemotherapy Infusion
This trial tests whether 30-minute massages to different body areas during chemo infusions can reduce anxiety in adult cancer patients who report at least moderate anxiety.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Irvine, California) |
| Trial ID | NCT07184294 on ClinicalTrials.gov |
What this trial studies
Adults receiving anticancer infusions are randomized to receive 30-minute massages to the feet/legs, head/neck/shoulder, hands/arms, a combination of all three, or no massage over five infusion sessions. The study measures feasibility and patient preference as primary outcomes, with changes in anxiety after each massage as a secondary outcome and other symptoms (pain, fatigue, nausea, depression, overall well-being) tracked with the ESAS as exploratory outcomes. Saliva samples are collected for biospecimen analysis. Deep-pressure massage is avoided and safety lab criteria (CBC, platelets, ANC) are required before participation.
Who should consider this trial
Good fit: Adults (≥18) receiving chemotherapy infusions who have completed at least one prior cycle, have a baseline anxiety score >3 on the VAS, are scheduled for at least six more infusions, and meet recent CBC/lab criteria are ideal candidates.
Not a fit: Patients with low baseline anxiety, those with contraindicating lab values (very low platelets or ANC), recent radiation to targeted areas, or those who dislike or cannot tolerate touch may not receive benefit.
Why it matters
Potential benefit: If successful, targeted massage during infusions could reduce patients' anxiety and improve comfort during chemotherapy sessions.
How similar studies have performed: Previous studies have shown massage can reduce pain, anxiety, nausea, fatigue, and depression in cancer patients, though randomized head-to-head comparisons of targeted infusion-time massages are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Irvine, California
- City of Hope at Irvine Lennar — Irvine, California, United States (Recruiting)
Study contacts
- Principal investigator: Richard T Lee — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.