Complementary/Integrative Medicine for Brain Cancer Patients

NCT ID: NCT03185780

Last Updated: 2018-11-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-12-31

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.

Conditions

Quality of Life; Chemotherapeutic Toxicity; Radiation Toxicity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Treatment

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)

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Touch Therapy - reflexology or Shiatsu

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Chaim Sheba Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Noah Samuels

Medical Director, Tal Center for Integrative Oncology, Institute of Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noah Samuels, MD

Role: PRINCIPAL_INVESTIGATOR

Tal Center for Integrative Oncology, Institute of Oncology, Chaim Sheba Medical Center, Israel

Other Identifiers

ChaimShebaMC

Identifier Type: -

Identifier Source: org_study_id