Complementary/Integrative Medicine for Brain Cancer Patients
- Conditions
- Chemotherapeutic ToxicityQuality of LifeRadiation Toxicity
- Interventions
- Other: Acupuncture
- Registration Number
- NCT03185780
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- inability/unwillingness to sign informed consent form
- unwillingness of treating oncologist to allow participation in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Acupuncture 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)
- Primary Outcome Measures
Name Time Method Functional Assessment of Cancer Therapy, Brain Cancer (FACT-Br) questionnaire 6 months Patient-Reported Outcome Measure - Quality of Life Assessment
Measure Yourself Concerns and Wellbeing (MYCAW) study tool 6 months Patient-Reported Outcome Measure - Quality of Life Assessment
Edmonton Symptom Assessment Scale (ESAS) 6 months Patient-Reported Outcome Measure - Quality of Life Assessment
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30) 6 months Patient-Reported Outcome Measure - Quality of Life Assessment
- Secondary Outcome Measures
Name Time Method Adverse effects attributed to the complementary/integrative medicine treatments 6 months Relates to the safety of the complementary medicine treatments
RDI - relative dose intensity 6 months Reflects adherence to the conventional chemo-radiation treatment regimen