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Complementary/Integrative Medicine for Brain Cancer Patients

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ClinicalTrials.gov Identifier: NCT03185780
Recruitment Status : Not yet recruiting
First Posted : June 14, 2017
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Noah Samuels, The Chaim Sheba Medical Center

Brief Summary:

Nearly a quarter of a million patients are diagnosed each year with tumors of the central nervous system, a third of them malignant. The most common malignant tumor of the brain is the high grade glioma( HGG), whose treatment begins with surgical resection of the tumor, followed by a combined chemo-radiation regimen, with the drug Temodal (temozolomide). This treatment is often accompanied by toxic effects (e.g., nausea, headache, constipation, weakness/fatigue, and others), with treatment of these effects limited in their effectiveness and safety. Complementary medicine treatments such as acupuncture and touch therapies (reflexology, Shiatsu, etc.) have been researched and found to be both safe and effective for some of the toxic effects of oncology treatment regimens.

The present pilot study is set to examine the impact of complementary medicine on the toxic effects of the conventional treatment for HGG. The study will include 40 patients and will last for two years, during which patients will be treated with acupuncture and/or touch therapies, this in parallel to their chemo-radiation regimen. The primary study outcome will be the scores on four Patient-Reported Outcome Measures (PROMs): the Measure Yourself Concerns and Wellbeing (MYCAW) study tool; the Functional Assessment of Cancer Therapy, Brain Cancer (FACT-Br) questionnaire; the Edmonton Symptom Assessment Scale (ESAS); and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30). Secondary study outcomes will include the safety of the complementary medicine treatments, and adherence to the planned oncology treatment regimen, as measured by the Relative Dose Intensity (RDI) calculation.


Condition or disease Intervention/treatment Phase
Quality of Life Chemotherapeutic Toxicity Radiation Toxicity Other: Acupuncture Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Patients with high grade glioma undergoing adjuvant (post-surgical) chemo-radiation treatment will be treated with acupuncture and/or touch therapies, this in parallel to their conventional treatment regimen. The primary study outcome will be the scores on four Patient-Reported Outcome Measures (PROMs): the Measure Yourself Concerns and Wellbeing (MYCAW) study tool; the Functional Assessment of Cancer Therapy, Brain Cancer (FACT-Br) questionnaire; the Edmonton Symptom Assessment Scale (ESAS); and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30). Secondary study outcomes will include the safety of the complementary medicine treatments, and adherence to the planned oncology treatment regimen, as measured by the Relative Dose Intensity (RDI) calculation.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Complementary/Integrative Medicine Treatments on Patients With Brain Cancer: A Pilot Study
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment
Patients will be treated with acupuncture and/or touch therapies, this in parallel to their chemo-radiation regimen. These treatments will be administered twice-weekly during active chemo-radiation treatment (6 weeks), followed by once-weekly treatment throughout the remainder of the study period (6 months)
Other: Acupuncture

Acupuncture: the insertion of use of ultra-fine needles (diameter 0.18 - 0.30mm) into designated "acupoints" in the skin, along the limbs and trunk areas.

Reflexology: The massage + application of localized pressure on designated points along the plantar aspect of the feet.

Shiatsu: The application of localized pressure along designated points (similar to "acupoints") along the limbs and trunk areas.

Other Name: Touch Therapy - reflexology or Shiatsu



Primary Outcome Measures :
  1. Measure Yourself Concerns and Wellbeing (MYCAW) study tool [ Time Frame: 6 months ]
    Patient-Reported Outcome Measure - Quality of Life Assessment

  2. Functional Assessment of Cancer Therapy, Brain Cancer (FACT-Br) questionnaire [ Time Frame: 6 months ]
    Patient-Reported Outcome Measure - Quality of Life Assessment

  3. Edmonton Symptom Assessment Scale (ESAS) [ Time Frame: 6 months ]
    Patient-Reported Outcome Measure - Quality of Life Assessment

  4. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30) [ Time Frame: 6 months ]
    Patient-Reported Outcome Measure - Quality of Life Assessment


Secondary Outcome Measures :
  1. Adverse effects attributed to the complementary/integrative medicine treatments [ Time Frame: 6 months ]
    Relates to the safety of the complementary medicine treatments

  2. RDI - relative dose intensity [ Time Frame: 6 months ]
    Reflects adherence to the conventional chemo-radiation treatment regimen



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient aged 18 years and older
  • diagnosed with high grade glioma (stage III-IV)
  • following surgical intervention (tumor resection)
  • prior to chemo-radiation treatment
  • signing of informed consent form

Exclusion Criteria:

  • inability/unwillingness to sign informed consent form
  • unwillingness of treating oncologist to allow participation in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185780


Contacts
Contact: Noah Samuels, MD 972-3-5307307 noah.samuels@sheba.health.gov.il

Sponsors and Collaborators
The Chaim Sheba Medical Center
Investigators
Principal Investigator: Noah Samuels, MD Tal Center for Integrative Oncology, Institute of Oncology, Chaim Sheba Medical Center, Israel

Responsible Party: Noah Samuels, Medical Director, Tal Center for Integrative Oncology, Institute of Oncology, The Chaim Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03185780     History of Changes
Other Study ID Numbers: ChaimShebaMC
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Noah Samuels, The Chaim Sheba Medical Center:
complementary/integrative medicine
glioblastoma
quality of life
adherence

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases