Chemotherapeutic Toxicity, Quality of Life, Radiation Toxicity
Conditions
Keywords
complementary/integrative medicine, glioblastoma, quality of life, adherence
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.
Interventions
OTHERAcupuncture
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.
Sponsors
The Chaim Sheba Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure Yourself Concerns and Wellbeing (MYCAW) study tool | 6 months | Patient-Reported Outcome Measure - Quality of Life Assessment |
| Functional Assessment of Cancer Therapy, Brain Cancer (FACT-Br) questionnaire | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed