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Hematopoietic and Lymphatic System NeoplasmNCT07184294

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

A study testing Best Practice, Biospecimen Collection and Massage Therapy in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Best Practice, Biospecimen Collection and Massage Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
26 Sep 2025to 28 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

    Richard T. Lee, 949-671-4091, RichLee@coh.org

    Richard T. Lee

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

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

EXPLORATORY OBJECTIVE:

  1. 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.

Being tested
Best Practice, Biospecimen Collection, Massage Therapy, Questionnaire Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best PracticeOther

    Also called standard of care, standard therapy

    Receive no massage therapy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo saliva sample collection

  • Massage TherapyProcedure or surgery

    Also called Massage

    Receive FL therapy

  • Massage TherapyProcedure or surgery

    Also called Massage

    Receive HNS therapy

  • Massage TherapyProcedure or surgery

    Also called Massage

    Receive HA therapy

  • Massage TherapyProcedure or surgery

    Also called Massage

    Receive combination FL, HNS, and HA therapy

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT07184294
Study groupRoleWhat they receive
Supportive Care (FL, HNS, HA, combination, no massage)ExperimentalPatients 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.
Receives: Other: Best Practice; Procedure: Biospecimen Collection; Procedure: Massage Therapy; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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]).

    Measured: Up to 1 year

  2. Completion rate

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

    Measured: Up to 1 year

Secondary outcomes (3)

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

    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.

    Measured: Up to 1 year

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

    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.

    Measured: Up to 1 year

  3. Change in anxiety levels salivary amylase)

    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.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2025
  2. Study start26 Sep 2025
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07184294
Sponsor's protocol ID
24302
Other IDs
NCI-2025-06187, 24302, P30CA033572
Status last verified
Oct 2026
First submitted
12 Sep 2025
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Best Practice, Biospecimen Collection and Massage Therapy in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 1 site 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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participation rate (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07184294.

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 26 Oct 2026.

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