Clinical trial NCT03185780: Complementary/Integrative Medicine for Brain Cancer Patients
Official title: Impact of Complementary/Integrative Medicine Treatments on Patients With Brain Cancer: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Quality of Life
Chemotherapeutic Toxicity
Radiation Toxicity
Keywords: complementary/integrative medicine
glioblastoma
quality of life
adherence
Lead sponsor: The Chaim Sheba Medical Center
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Measure Yourself Concerns and Wellbeing (MYCAW) study tool
timeFrame: 6 months
measure: Functional Assessment of Cancer Therapy, Brain Cancer (FACT-Br) questionnaire
timeFrame: 6 months
measure: Edmonton Symptom Assessment Scale (ESAS)
timeFrame: 6 months
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30)
timeFrame: 6 months
Secondary outcomes:
measure: Adverse effects attributed to the complementary/integrative medicine treatments
timeFrame: 6 months
measure: RDI - relative dose intensity
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Tal Center for Integrative Oncology, Institute of Oncology, Chaim Sheba Medical Center, Israel
name: Noah Samuels, MD
role: PRINCIPAL_INVESTIGATOR
References: