Quality of LifeNCT03185780
Complementary/Integrative Medicine for Brain Cancer Patients
A study testing Acupuncture in people with Quality of Life and Chemotherapeutic Toxicity, run by The Chaim Sheba Medical Center.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Chemotherapeutic Toxicity, Radiation Toxicity
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- inability/unwillingness to sign informed consent form
- unwillingness of treating oncologist to allow participation in the study
About this study
Official title: 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.
- Being tested
- Acupuncture
- Keywords
- complementary/integrative medicine, glioblastoma, quality of life, adherence
- Medical subject headings
- Radiation Injuries, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Also called Touch Therapy - reflexology or Shiatsu
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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) Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Yourself Concerns and Wellbeing (MYCAW) study tool
Patient-Reported Outcome Measure - Quality of Life Assessment
Measured: 6 months
Functional Assessment of Cancer Therapy, Brain Cancer (FACT-Br) questionnaire
Patient-Reported Outcome Measure - Quality of Life Assessment
Measured: 6 months
Edmonton Symptom Assessment Scale (ESAS)
Patient-Reported Outcome Measure - Quality of Life Assessment
Measured: 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
Measured: 6 months
Secondary outcomes (2)
Adverse effects attributed to the complementary/integrative medicine treatments
Relates to the safety of the complementary medicine treatments
Measured: 6 months
RDI - relative dose intensity
Reflects adherence to the conventional chemo-radiation treatment regimen
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 Jul 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Why it stopped: Unable to attain funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Chaim Sheba Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noah Samuels, The Chaim Sheba Medical Center
- Investigators
- Noah Samuels, MD, Principal investigator, Tal Center for Integrative Oncology, Institute of Oncology, Chaim Sheba Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185780
- Sponsor's protocol ID
- ChaimShebaMC
- Status last verified
- Nov 2018
- First submitted
- 8 Jun 2017
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Complementary/Integrative Medicine Treatments on Patients With Brain Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT03185780
- Acronym / sponsor ID
- ChaimShebaMC
- Keywords
- complementary/integrative medicine, glioblastoma, quality of life, adherence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to attain funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Chaim Sheba Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: AcupuncturePatients 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- inability/unwillingness to sign informed consent form
- unwillingness of treating oncologist to allow participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAlso: Touch Therapy - reflexology or ShiatsuAcupuncture: 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 | Treatment |
Primary outcome
Measure Yourself Concerns and Wellbeing (MYCAW) study tool
Time frame: 6 months
Patient-Reported Outcome Measure - Quality of Life Assessment
Functional Assessment of Cancer Therapy, Brain Cancer (FACT-Br) questionnaire
Time frame: 6 months
Patient-Reported Outcome Measure - Quality of Life Assessment
Edmonton Symptom Assessment Scale (ESAS)
Time frame: 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)
Time frame: 6 months
Patient-Reported Outcome Measure - Quality of Life Assessment
2 secondary outcomes
Adverse effects attributed to the complementary/integrative medicine treatments
Time frame: 6 months
RDI - relative dose intensity
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Samuels, MD principal investigator
Tal Center for Integrative Oncology, Institute of Oncology, Chaim Sheba Medical Center, Israel
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Quality of Life and Chemotherapeutic Toxicity, run by The Chaim Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure Yourself Concerns and Wellbeing (MYCAW) study tool (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018.