CancerNCT06892158
Massage Impact on Sleep in Pediatric Oncology
A study testing Massage therapy in people with Cancer and Pediatric Cancer, run by Children's Hospital of Philadelphia at 2 sites in United States.
Trial summary
This study aims to determine the impact of massage therapy for pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT). Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Cancer, Pediatric Cancer, Chemotherapy Effect
- What is being tested?
- Massage therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jan 2025to Jul 2028
- 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 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of cancer, such as acute myeloid leukemia (AML) or relapsed acute lymphoblastic leukemia (rALL) OR admitted to receive autologous or allogeneic HSCT for any indication
- Expected to be an inpatient for at least 21 days
- Aged 12 to 21 years at enrollment.
- Inpatient at Children's National or Children's Hospital of Philadelphia (CHOP).
Who cannot join
- Cognitive impairment sufficient to preclude completing questionnaires appropriately
- Insufficient knowledge of English or Spanish that would prohibit completing the study instruments
- Previous enrollment
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Tracey Jubelirer, MD, jubelirer@chop.edu
Lauren Vernau, vernaul@chop.edu
- Not yet recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Catriona Mowbray, PhD, 202-476-3723
About this study
Official title: Massage Impact on Sleep in Hospitalization for Pediatric Oncology and Stem Cell Transplant Patients
This study aims to determine the impact of massage therapy for pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT).
Read the detailed description
Hospitalized pediatric oncology patients report anxiety, pain, disturbed sleep, and excess fatigue. Massage is safe, does not interfere with medications, and has been shown in limited studies to have efficacy in improving sleep as well as decreasing fatigue, anxiety and other symptoms in cancer patients and children with various ailments.
This project aims to determine if individualized massage therapy for hospitalized pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT) is associated with longer duration and improved quality of sleep, more robust circadian rhythms (CARs), improved quality of life (QOL) and reduced fatigue, anxiety, and pain, as compared to a standard of care group.
- Conditions
- Cancer, Pediatric Cancer, Chemotherapy Effect, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Pediatric, Hematopoietic Stem Cell Transplantation (HSCT)
- Being tested
- Massage therapy, Standard of care
- Keywords
- Stem cell transplant (SCT), Decreased sleep efficiency, Pediatric cancer diagnosis, Circadian activity rhythm (CAR)
- Medical subject headings
- Neoplasms, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage therapyOther
Participants in IA will receive a 20-30-minute massage five days per week for 21 days.
Standard of careOther
Institutional standard of care treatment
| Study group | Role | What they receive |
|---|---|---|
| Control Arm (CA) | Active comparator | Standard of care. Receives: Other: Standard of care |
| Intervention Arm (IA) | Experimental | Massage therapy Receives: Other: Massage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total sleep minutes
Change in the total number of sleep minutes over time in the standard of care intervention compared to the change in the total number of sleep minutes over time in the massage therapy intervention. Sleep minutes are measured by actigraphy.
Measured: 3 weeks
Secondary outcomes (1)
Change in sleep quality as demonstrated by circadian activity rhythms (CARs)
Amount of dysrgulation in CARs in the standard of care intervention compared to the amount of dysregulation in CARs in the massage therapy intervention. Dysregulation in CARs will be measured by actigraphy (24-h autocorrelation).
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start23 Jan 2025
- Primary completionJan 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized, two-group design (intervention arm, IA and control arm, CA).
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Massage Therapy Foundation, Children's National Research Institute
- Responsible party
- Sponsor
- Investigators
- Tracey Jubelirer, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892158
- Sponsor's protocol ID
- 24-022048
- Status last verified
- Apr 2026
- First submitted
- 18 Mar 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massage Impact on Sleep in Hospitalization for Pediatric Oncology and Stem Cell Transplant Patients
- ClinicalTrials.gov ID
- NCT06892158
- Acronym / sponsor ID
- 24-022048
- Conditions
- Cancer, Pediatric Cancer, Chemotherapy Effect, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Pediatric, Hematopoietic Stem Cell Transplantation (HSCT)
- Keywords
- Stem cell transplant (SCT), Decreased sleep efficiency, Pediatric cancer diagnosis, Circadian activity rhythm (CAR)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Massage Therapy Foundation, Children's National Research Institute
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the impact of massage therapy for pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT).
Detailed description
Hospitalized pediatric oncology patients report anxiety, pain, disturbed sleep, and excess fatigue. Massage is safe, does not interfere with medications, and has been shown in limited studies to have efficacy in improving sleep as well as decreasing fatigue, anxiety and other symptoms in cancer patients and children with various ailments.
This project aims to determine if individualized massage therapy for hospitalized pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT) is associated with longer duration and improved quality of sleep, more robust circadian rhythms (CARs), improved quality of life (QOL) and reduced fatigue, anxiety, and pain, as compared to a standard of care group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a randomized, two-group design (intervention arm, IA and control arm, CA).
| Arm | Type | Receives |
|---|---|---|
| Control Arm (CA) | Active comparator | Other: Standard of careStandard of care. |
| Intervention Arm (IA) | Experimental | Other: Massage therapyMassage therapy |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosis of cancer, such as acute myeloid leukemia (AML) or relapsed acute lymphoblastic leukemia (rALL) OR admitted to receive autologous or allogeneic HSCT for any indication
- Expected to be an inpatient for at least 21 days
- Aged 12 to 21 years at enrollment.
- Inpatient at Children's National or Children's Hospital of Philadelphia (CHOP).
Key exclusion criteria (3 listed)
- Cognitive impairment sufficient to preclude completing questionnaires appropriately
- Insufficient knowledge of English or Spanish that would prohibit completing the study instruments
- Previous enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage therapyParticipants in IA will receive a 20-30-minute massage five days per week for 21 days. | Other | Intervention Arm (IA) |
| Standard of careInstitutional standard of care treatment | Other | Control Arm (CA) |
Primary outcome
Change in total sleep minutes
Time frame: 3 weeks
Change in the total number of sleep minutes over time in the standard of care intervention compared to the change in the total number of sleep minutes over time in the massage therapy intervention. Sleep minutes are measured by actigraphy.
1 secondary outcome
Change in sleep quality as demonstrated by circadian activity rhythms (CARs)
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tracey Jubelirer, MD principal investigator
Children's Hospital of Philadelphia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage therapy in people with Cancer and Pediatric Cancer, run by Children's Hospital of Philadelphia at 2 sites 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 4 inclusion and 3 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Lauren Vernau (267-426-1162, vernaul@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total sleep minutes (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.