Introduction:

This lay summary is intended to provide a general overview of the Children’s Oncology Group study # ACCL1032. It will provide information about the children that are eligible for this study and basic information regarding the specifics of the study. The informed consent and protocol contain the full details of the study. Those documents are available to you from your oncologist.

This study is a cancer control study. If you consent to being a part of this study, the child enrolled will be asked to fill out forms regarding the intensity of their nausea. This research is done to look at alternative methods to control chemotherapy induced nausea and vomiting.
It is important to understand that participating in a clinical trial is entirely voluntary. The decision about whether or not to participate will not affect the care provided by the healthcare team in any way.
You can find additional information about participation on clinical trials on www.childrensoncologygroup.org. Always discuss any questions that you may have with your healthcare team.

Brief Title: ACCL1032: A study evaluating acupressure as a measure to control chemotherapy-induced nausea (CIN) and vomiting.

Official Title: ACCL1032: A Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea (CIN) in Children Receiving Cisplatin.

Trial Opening Date: May 2, 2011

General Patient Eligibility:

Please consult your doctor to determine whether your child may participate in this study.
Patient Age: 4 to 18 years of age

For patients with:

  • Newly diagnosed CNS tumors
  • Newly diagnosed non-CNS solid tumors

Other major enrollment criteria:

  • Must be receiving first course of Cisplatin (dose =50mg/m2/dose), may have received other agents before cisplatin course
  • Must be able to read/speak English
  • Enrollment within 5 days of start of protocol

Patients with the following may not be eligible:

  • Planned used of scheduled corticosteroids in CNS tumor patients
  • Use of Aprepitant
  • History of use of Acupressure
  • Patients enrolled in COG study protocol # ACCL0431

General Background and Study Goal

When receiving chemotherapy there is often associated nausea and vomiting. It is standard care to receive medication along with the chemotherapy to prevent or reduce these side effects. Nausea caused by chemotherapy has been reported to be very distressing to cancer patients and negatively impacts their quality of life. This study looks at how well adding a treatment called acupressure to the standard treatment works for treating the nausea and vomiting that can come with cisplatin. Acupressure uses elastic wrist bands worn during and after chemotherapy. There is a pressure point in the wrist that is believed to control nausea and vomiting. Use of acupressure in adults has shown to have positive results in improving chemotherapy-induced nausea. This study will see if acupressure is helpful in reducing nausea and vomiting in children receiving chemotherapy.

In this study, the patient will either get the standard treatment plus real acupressure treatment bands or the standard treatment plus placebo (fake) acupressure treatment bands. Placebo treatment bands look and feel similar to the real acupressure treatment bands but may not have the same effect. The treatment plan they receive is decided by a process called randomization. Randomization means that the treatment is assigned based on chance. It is a lot like flipping a coin, except that it is done by computer to make sure that there are about the same number of people on each treatment plan of the study. The randomization takes place at the time you are enrolled on the study. You have an equal chance of getting either one of the treatments.

The goals of this study:

Primary Objectives:
1. To compare the control of nausea using true and placebo acupressure in the acute phase (prior to start of chemotherapy until 24hrs after last dose of chemotherapy)

Secondary Aims:
1. To compare the control of nausea using true and placebo acupressure in the delayed phase (24hrs after last dose of chemotherapy up to 7 days from last dose of chemotherapy). 2. To compare the control of vomiting using true and placebo acupressure in the acute and delayed phases

Summary of the Treatment

For patients receiving Cisplatin =50mg/m2/dose

  • Patient eligible for study randomized to placebo acupressure or true acupressure bands
  • Wrist band will be applied prior to start of chemotherapy and worn for up to 7 days after the last dose of chemotherapy given
  • Chemotherapy-induced nausea (CIN) severity and Chemotherapy-induced vomiting (CIV) will be assessed using the Pediatric Nausea Assessment Tool (PeNAT):
    • On each day that chemotherapy is administered
    • For 24 hours following the last chemotherapy dose (Acute Phase)
    • Up to 7 days thereafter (Delayed Phase).
  • Chemotherapy-induced nausea (CIN) severity will be assessed using the Pediatric Nausea Assessment Tool (PeNAT):
      • Within 3 hrs before the first chemotherapy dose
      • At least 4 times a day (on awakening, mid-day, late afternoon, and
      • bedtime

    • Plus any time the patient feels nauseated or the parent/guardian suspects that the child feels nauseated

Risks and Side Effects

Chemotherapy can cause short- and long-term side effects. All patients will be closely monitored to reduce the likelihood of negative side effects. All risks and side effects will be explained in detail by your healthcare team during the consent process. They can answer any questions that you may have regarding participation on the clinical trial or other aspects of care. Please refer to the consent document for a detailed explanation of the side effects associated with the treatment on this study.

The risks of acupressure are very small. You may feel some pressure on your wrists from wearing the acupressure bands. You will be allowed to take the bands off for up to 15 minutes at a time, up to 4 times a day (total of 60 minutes a day) if you wish, for example to take a shower or bath. If you remove the bands for longer periods, you may not be able to complete the study.

Contact Information

Your child’s oncologist is the best source for further information. Physicians with eligible patients should refer questions to the principal investigator:

Principal Investigator
Co-Study Chair: Thomas McLean, MD
Wake Forest University School of Medicine
Winston-Salem, NC
Phone: (336) 716-4085
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

Co-Study Chair: Lee Dupuis
The Hospital for Sick Children
Toronto ON Canada
Phone: (416) 813-6475
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

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