Massage Therapy for Pediatric Cancer

Recruiting at 2 trial locations

Overseen By Lauren Vernau

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Cognitive impairment, Language barrier, Previous enrollment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether massage therapy can aid children and teens undergoing intense cancer treatments, such as chemotherapy or stem cell transplants. It compares the effects of massage therapy with standard care to determine if it improves comfort and well-being. Children and teens with cancer, such as certain types of leukemia, who expect to stay in the hospital for at least three weeks may qualify. Participants must receive treatment at specific hospitals in Washington, D.C., or Philadelphia. As an unphased trial, this study provides a unique opportunity to contribute to understanding how massage therapy might enhance comfort during cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that massage therapy is safe for pediatric cancer patients?

Research has shown that massage therapy is a safe option for children with cancer. Studies have found it reduces pain and stress without medication. For instance, one study discovered that massage can lower stress hormone levels and improve the immune system in young patients. Another study noted that massage is well-received and meaningful for children undergoing cancer treatment. Importantly, no reports of serious side effects exist. This makes massage therapy a gentle and supportive addition to traditional treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Massage therapy is unique because it offers a non-invasive, soothing approach that differs from the standard treatments for pediatric cancer, which often involve chemotherapy, radiation, and surgery. Unlike these traditional methods, massage therapy aims to improve the quality of life by reducing stress and pain, rather than directly targeting cancer cells. Researchers are excited about this approach because it may enhance overall well-being and provide comfort to young patients without adding to the physical burden of cancer treatments.

What evidence suggests that massage therapy might be an effective treatment for pediatric cancer patients?

Studies have shown that massage therapy can help children with cancer by reducing tiredness and pain, thus increasing comfort. Research indicates that it can also lower stress and anxiety during challenging treatments like chemotherapy or stem cell transplants. A review of several clinical trials found that massage therapy consistently aids in these areas. In this trial, participants in the intervention arm will receive massage therapy, while those in the control arm will receive standard care. These findings suggest that massage therapy could be a beneficial addition to standard care for children with cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Tracey Jubelirer, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for children with certain types of cancer (like ALL or AML) who are undergoing intensive chemotherapy or a stem cell transplant. Specific eligibility details aren't provided, but typically participants must meet health and treatment criteria.

Inclusion Criteria

I will be hospitalized for at least 21 days.

I have been diagnosed with AML, rALL, or am getting a stem cell transplant.

I am between 12 and 21 years old.

Exclusion Criteria

Previous enrollment

I am not fluent in English or Spanish to complete study forms.

I have difficulty thinking or remembering that makes it hard for me to fill out forms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard of care or massage therapy while undergoing intensive chemotherapy or stem cell transplant

3 weeks

In-hospital treatment

Follow-up

Participants are monitored for improvement in sleep quality and total sleep minutes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Massage Therapy

Trial Overview The study is testing whether massage therapy can improve sleep quality in pediatric oncology patients compared to the standard care they receive during intensive chemotherapy or SCT.

How Is the Trial Designed?

Group I: Intervention Arm (IA) Experimental Treatment 1 Intervention

Massage therapy

Group II: Control Arm (CA) Active Control 1 Intervention

Standard of care.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Children's National Research Institute

Collaborator

Trials

227

Recruited

258,000+

Massage Therapy Foundation

Collaborator

Trials

8

Recruited

380+

Published Research Related to This Trial

A study involving 243 pediatric patients with hematologic and oncologic conditions showed that massage therapy significantly reduced pain, stress, and anxiety, with all patients reporting clinically meaningful improvements after treatment.

Patients with sickle cell disease experienced higher levels of pain, stress, and anxiety before treatment compared to those with other hematologic or oncologic conditions, but all groups benefited from massage therapy, particularly the HemOnc group which reported greater reductions in pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Massage therapy for children, adolescents, and young adults: Clinical delivery and effectiveness in hematology and oncology. Rodgers-Melnick, SN., Bartolovich, M., Desai, NJ., et al.[2023]

A systematic review of 7 clinical trials involving children with cancer found that therapeutic massage can significantly reduce symptoms such as pain, nausea, stress, and anxiety, while also increasing white blood cells and neutrophils.

Different massage techniques, including Swedish massage and effleurage, were used in the studies, indicating that massage may be a beneficial complementary therapy for managing symptoms in pediatric cancer patients, although further research is needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the application of therapeutic massage in children with cancer: a systematic review. Rodríguez-Mansilla, J., González-Sánchez, B., Torres-Piles, S., et al.[2022]

A systematic review of 60 studies on massage therapy in children found that while many studies did not report adverse events (AEs), 26.6% reported at least one AE, ranging from mild to severe.

Notably, there was a concerning association between abdominal massage and severe AEs, including volvulus in premature infants, which raises safety concerns and suggests caution in using abdominal massage for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with paediatric massage therapy: a systematic review. Karkhaneh, M., Zorzela, L., Jou, H., et al.[2022]

Massage therapy (MT) significantly improved psychological well-being in pediatric oncology and hematology patients, reducing state and trait anxiety and enhancing emotional state, based on a study of 30 children aged 6 months to 17 years.

MT also led to notable physical benefits, including reduced muscle soreness, discomfort, and improved respiratory rate, indicating that it can enhance the overall quality of life for children with cancer and blood diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Children with cancer and blood diseases experience positive physical and psychological effects from massage therapy. Haun, JN., Graham-Pole, J., Shortley, B.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6352174/

The Power of Massage in Children with Cancer—How Can ... Massage therapy decreases cancer-related fatigue: Results from a randomized early phase trial. Cancer. 2018;124:546–554. doi: 10.1002/cncr ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0021755713001654

Massage in children with cancer: effectiveness of a protocol Conclusions. despite the small sample size, massage therapy appears to be a useful intervention in reducing pain in children with cancer. However, there are ...

3. uhhospitals.org uhhospitals.org/for-clinicians/articles-and-news/articles/2023/06/uh-rainbow-a-national-leader-in-massage-therapy-for-pediatric-cancer-and-sickle-cell-disease

UH Rainbow a National Leader in Massage Therapy for ... Impact for Patients. Study results show that massage therapy provided by a CPMT is indeed meaningful for pediatric patients with cancer or SCD.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00698113

Parent-Delivered Massage in Paediatric Cancer The purpose of this study is to determine how parents of children with cancer rate a parent-delivered massage therapy educational program for usability and ...

5. commons.case.edu commons.case.edu/cgi/viewcontent.cgi?article=1028&context=studentworks

Clinical Delivery and Effectiveness in Hematology and Oncology Specifically, a review of seven clinical trials (sample size range: 17–. 171) reported that MT contributed to decreased pain, stress, anxiety,.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK76491/

Massage therapy as a supportive care intervention for children ... These studies reported on the impact of massage on stress hormone levels and immune system activity, impact on pain, nausea or vomiting in cancer patients, ...