Complementary/Integrative Medicine for Brain Cancer Patients

Study Overview
=================
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.

Official Title
-----------------
Impact of Complementary/Integrative Medicine Treatments on Patients With Brain Cancer: A Pilot Study

Conditions
-----------------
Quality of Life, Chemotherapeutic Toxicity, Radiation Toxicity

Intervention / Treatment
-----------------
* Other: Acupuncture


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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<br>* 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.<br>* Other names: Touch Therapy - reflexology or Shiatsu;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure Yourself Concerns and Wellbeing (MYCAW) study tool | Patient-Reported Outcome Measure - Quality of Life Assessment | 6 months | 
| Functional Assessment of Cancer Therapy, Brain Cancer (FACT-Br) questionnaire | Patient-Reported Outcome Measure - Quality of Life Assessment | 6 months | 
| Edmonton Symptom Assessment Scale (ESAS) | Patient-Reported Outcome Measure - Quality of Life Assessment | 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects attributed to the complementary/integrative medicine treatments | Relates to the safety of the complementary medicine treatments | 6 months | 
| RDI - relative dose intensity | Reflects adherence to the conventional chemo-radiation treatment regimen | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
complementary/integrative medicine, glioblastoma, quality of life, adherence