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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Measure Yourself Concerns and Wellbeing (MYCAW) study tool
Patient-Reported Outcome Measure - Quality of Life Assessment
Time frame: 6 months
Functional Assessment of Cancer Therapy, Brain Cancer (FACT-Br) questionnaire
Patient-Reported Outcome Measure - Quality of Life Assessment
Time frame: 6 months
Edmonton Symptom Assessment Scale (ESAS)
Patient-Reported Outcome Measure - Quality of Life Assessment
Time frame: 6 months
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30)
Patient-Reported Outcome Measure - Quality of Life Assessment
Time frame: 6 months
Adverse effects attributed to the complementary/integrative medicine treatments
Relates to the safety of the complementary medicine treatments
Time frame: 6 months
RDI - relative dose intensity
Reflects adherence to the conventional chemo-radiation treatment regimen
Time frame: 6 months
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