Different Types of Massage Therapy to Reduce Anxiety During Chemotherapy Infusion in Patients With Cancer

NCT07184294 | Recruiting DMC

• 3 other identifiers: 24302NCI-2025-06187P30CA033572
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial tests how well different types of massage therapy works to reduce anxiety during chemotherapy infusions in patients with cancer. Many cancer patients experience moderate to severe anxiety and anxiety can worsen by the anticipation of medical procedures that patients have to receive, particularly chemotherapy. Massage therapy, as a complementary treatment, has shown promise in lessening both physical and psychological symptoms associated with cancer and its treatments. Research has also shown the benefits of massage therapy in reducing pain, stress, anxiety, nausea (upset stomach), fatigue (tiredness), and depression in cancer patients. Different types of massage therapy may potentially reduce some cancer patients' symptoms, enhance their treatment, and reduce treatment related side effects.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• Participation rate

  Will consider the study feasible if \>=70% of patients are able to complete the massage intervention at each session. Descriptive summary will be provided (including 95% confidence intervals \[CI\]).

  Up to 1 year

• Completion rate

  Descriptive summary will be provided (including 95% CI).

  Up to 1 year

Secondary Outcomes (3)

• Change in anxiety levels (State-Trait Anxiety Inventory)

  Up to 1 year

• Change in anxiety levels (Edmonton Symptom Assessment System)

  Up to 1 year

• Change in anxiety levels salivary amylase)

  Up to 1 year

Study Arms (1)

Supportive Care (FL, HNS, HA, combination, no massage)

EXPERIMENTAL

Patients receive massage therapy according to a randomized schedule to the FL, HNS, hands/arms (HA), combination of all three groups (FL, HNS, HA) or no massage therapy over 30 minutes over 5 chemotherapy sessions total on study. Patients also undergo saliva sample collection on study.

Other: Best Practice; Procedure: Biospecimen Collection; Procedure: Massage Therapy; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive no massage therapy

Also known as: standard of care, standard therapy

Supportive Care (FL, HNS, HA, combination, no massage)

Biospecimen Collection PROCEDURE

Undergo saliva sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Supportive Care (FL, HNS, HA, combination, no massage)

Massage Therapy PROCEDURE

Receive FL therapy

Also known as: Massage

Supportive Care (FL, HNS, HA, combination, no massage)

Questionnaire Administration OTHER

Ancillary studies

Supportive Care (FL, HNS, HA, combination, no massage)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

RECRUITING

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care; Specimen Handling; Massage

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Richard T Lee

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 19, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): November 28, 2026
• Study Completion (Estimated): November 28, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

US (1)