Complementary/Integrative Medicine for Brain Cancer Patients

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Quality of Life; Radiation Toxicity; Chemotherapeutic Toxicity
• Intervention / Treatment: Other: Acupuncture

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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)

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.; 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

Collaborators and Investigators

• Sponsor: The Chaim Sheba Medical Center
• Investigators: Principal Investigator: Noah Samuels, MD, Tal Center for Integrative Oncology, Institute of Oncology, Chaim Sheba Medical Center, Israel

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2018
• Primary Completion (ANTICIPATED): December 31, 2019
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: June 8, 2017
• First Submitted That Met QC Criteria: June 11, 2017
• First Posted (ACTUAL): June 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 28, 2018
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: quality of life; adherence; glioblastoma; complementary/integrative medicine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: ChaimShebaMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No