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NCT Number: NCT07184294

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

Location status: Recruiting

Location contact

Richard T. Lee

CONTACT

[email protected]

949-671-4091

Richard T. Lee

PRINCIPAL_INVESTIGATOR

About this study

PRIMARY OBJECTIVES:

I. To assess the feasibility of 30-minute massages targeting various body regions among patients with cancer receiving anticancer therapy infusion.

II. Assess which type of massage is preferred by patients with cancer receiving anticancer therapy infusion.

SECONDARY OBJECTIVE:

I. To assess the change in anxiety levels after each type of massage therapy during infusion.

EXPLORATORY OBJECTIVE:

I. To evaluate changes in other symptoms, such as: pain, fatigue, nausea, depression, and overall well-being, using data obtained from the Edmonton Symptoms Assessment scale (ESAS) after each type of massage therapy.

OUTLINE:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Receive no massage therapy

Other names: standard of care, standard therapy

Biospecimen Collection

Procedure

Undergo saliva sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Massage therapy

Procedure

Receive FL therapy

Other names: Massage

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Participation rate

    Time frame: Up to 1 year

    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]).

  2. Completion rate

    Time frame: Up to 1 year

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

Secondary outcomes

  1. Change in anxiety levels (State-Trait Anxiety Inventory)

    Time frame: Up to 1 year

    Will be assessed by the items from the State-Trait Anxiety Inventory. Will use paired t-tests to assess the impact of each massage intervention, by comparing changes in outcome measures from pre to post intervention within each session. Second, will apply mixed effect models to evaluate the main effects of interventions and time points (and their interaction) on the changes in outcome measures, while accounting for the individual differences, session variability, as well as missing data. These analyses will provide estimates and effect sizes to help inform the design of future studies. They are intended to detect a signal rather than test a formal hypothesis.

  2. Change in anxiety levels (Edmonton Symptom Assessment System)

    Time frame: Up to 1 year

    Will be assessed by the items from the Edmonton Symptom Assessment System. Will use paired t-tests to assess the impact of each massage intervention, by comparing changes in outcome measures from pre to post intervention within each session. Second, will apply mixed effect models to evaluate the main effects of interventions and time points (and their interaction) on the changes in outcome measures, while accounting for the individual differences, session variability, as well as missing data. These analyses will provide estimates and effect sizes to help inform the design of future studies. They are intended to detect a signal rather than test a formal hypothesis.

  3. Change in anxiety levels salivary amylase)

    Time frame: Up to 1 year

    Will be assessed by the items from the salivary amylase. Will use paired t-tests to assess the impact of each massage intervention, by comparing changes in outcome measures from pre to post intervention within each session. Second, will apply mixed effect models to evaluate the main effects of interventions and time points (and their interaction) on the changes in outcome measures, while accounting for the individual differences, session variability, as well as missing data. These analyses will provide estimates and effect sizes to help inform the design of future studies. They are intended to detect a signal rather than test a formal hypothesis.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Assessing the Feasibility of Different Types of Massage to Reduce Anxiety During Chemotherapy Infusion

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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