Complementary/Integrative Medicine for Brain Cancer Patients

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03185780
• Other study ID #: ChaimShebaMC
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2018
• Source: The Chaim Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Chemotherapeutic Toxicity
• Quality of Life
• Radiation Toxicity

Intervention

Other:
• Acupuncture
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Chaim Sheba Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure Yourself Concerns and Wellbeing (MYCAW) study tool	Patient-Reported Outcome Measure - Quality of Life Assessment	6 months
Primary	Functional Assessment of Cancer Therapy, Brain Cancer (FACT-Br) questionnaire	Patient-Reported Outcome Measure - Quality of Life Assessment	6 months
Primary	Edmonton Symptom Assessment Scale (ESAS)	Patient-Reported Outcome Measure - Quality of Life Assessment	6 months
Primary	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	Adverse effects attributed to the complementary/integrative medicine treatments	Relates to the safety of the complementary medicine treatments	6 months
Secondary	RDI - relative dose intensity	Reflects adherence to the conventional chemo-radiation treatment regimen	6 months