Breast NeoplasmsPhase 1/2NCT02781155
Limiting Chemotherapy Side Effects by Using Moxa
A Phase 1/2 study testing Moxibustion in people with Breast Neoplasms and Colorectal Neoplasms, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
Trial summary
This study investigates whether it is feasible to teach cancer patients undergoing chemotherapy to self-administer daily moxibustion to reduce chemotherapy side effects. Moxibustion is a therapy used in traditional Chinese medicine that uses heat. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Neoplasms, Colorectal Neoplasms, Genital Neoplasms, Female
- What is being tested?
- Moxibustion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Sep 2017
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- with breast, gynaecologic, or colorectal cancer who are prescribed radical or adjuvant chemotherapy in the early disease setting, or first or second line chemotherapy is in the metastatic setting
- about to commence a course of chemotherapy for which granulocyte-colony stimulating factor (G-CSF) is not routinely indicated
- with a life expectancy of more than six months
- with blood cell counts within the normal range
- with calculated creatinine levels of ≥ 50ml/min
- English speaking
- able to understand instructions for self-administration of moxibustion and carry out the procedure
- able to give informed consent
Who cannot join
- having a haematological cancer diagnosis
- prescribed a chemotherapy regimen for which G-CSF is indicated
- having third or fourth line chemotherapy
- having metastatic bone cancer
- who have concomitant severe medical problems preventing participation
- with cognitive impairment that would impact participant's ability to safely administer self-moxibustion
- having renal dysfunction
- with lymphedema in the lower body.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Mount Vernon Cancer Centre
Northwood, Middlesex, HS6 2RN
Clare Scarlett, BA (Hons), +44 203 826 2561, clare.scarlett1@nhs.net
Beverley A de Valois, PhD, +44 203 826 2556, beverley.devalois@nhs.net
About this study
Official title: Using Daily Self-administered Indirect Moxibustion to Zusanli St-36 to Reduce Chemotherapy Induced Pancytopenia: a Feasibility Study
This study investigates whether it is feasible to teach cancer patients undergoing chemotherapy to self-administer daily moxibustion to reduce chemotherapy side effects. Moxibustion is a therapy used in traditional Chinese medicine that uses heat.
Read the detailed description
Chemotherapy drugs are used to treat cancer cells. However, they can also affect bone marrow and reduce the ability to make certain types of blood cells. Low white blood cell counts can leave patients vulnerable to infection. Low red blood cell counts can lead to anaemia and feelings of fatigue and weakness. Low platelet counts can lead to bruising and bleeding. Blood counts are therefore monitored. If they fall too low, the dose of chemotherapy may be reduced or the time between doses extended. This may affect survival as well as quality of life.
Research studies in China and the West suggest that moxibustion applied by a practitioner can improve blood counts and immunity, and reduce side effects of chemotherapy. Moxibustion (also called moxa) is a form of traditional Chinese medicine that uses heat to stimulate acupuncture points. This heat comes from a smouldering herb called mugwort, that is rolled into a cigar shape to gently warm the point. Many patients regard this as a pleasant, relaxing experience.
The researchers will teach patients to self-administer moxa to an acupuncture point just below the knee. This is a feasibility study to see if patients are willing and able to self-administer moxa daily throughout chemotherapy. Patients will keep a moxa diary to record their activity. The researchers will also use a questionnaire to assess whether patients see themselves as active managers of their health. This may help the researchers to screen suitable patients in future studies.
The researchers will also monitor blood counts, any delays or dose reductions to the chemotherapy, and any chemotherapy side effects. Participants will complete quality of life questionnaires at intervals during and after their chemotherapy.
If results are favourable, they will be used to design a randomised controlled trial comparing daily moxibustion with a "no treatment" control arm.
- Conditions
- Breast Neoplasms, Colorectal Neoplasms, Genital Neoplasms, Female, Toxicity Due to Chemotherapy
- Being tested
- Moxibustion
- Keywords
- Health related quality of life, Moxibustion, Cancer, Chemotherapy, Neutropenia, Anaemia, Thrombocytopenia, Self management, Wellbeing
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Genital Neoplasms, Female, Neoplasms, Neutropenia, Anemia, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxibustionOther
Also called Moxa
Participants are taught to self administer moxibustion to acupuncture point Zusanli St-36 daily throughout the course of their chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Self administration of moxibustion | Other | Participants will be taught to self administer moxibustion to the acupuncture point Zusanli St-36, and apply it daily throughout their chemotherapy treatments Receives: Other: Moxibustion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to moxa regimen assessed by Daily Moxa Diary
The primary aim of this study is to assess the feasibility of teaching cancer patients undergoing chemotherapy in the National Health Service (NHS) to self-administer daily indirect moxibustion to St 36 Zusanli, according to a protocol that begins ideally 7 to 10 days prior to the first chemotherapy cycle and continues until 21 days after the final chemotherapy cycle. Participants will complete a Daily Moxa Diary to record their adherence to the daily protocol. They will be asked also to log any days they miss, and give reasons why.
Measured: 21 days after last chemotherapy cycle
Secondary outcomes (7)
Blood counts, specifically white blood cells, neutrophils, haemoglobin, and platelets
Blood counts will be collected from the participants' medical notes to monitor incidents of neutropenia, anaemia, or thrombocytopenia.
Measured: Throughout chemotherapy, on 1st day of each cycle, according to chemotherapy schedule. This is usually fortnightly for colorectal (Days 1, 15, 19, 43, 57, 71, 85, 99) and 3-weekly for breast and gynaecologic cancers (Days 1, 22, 43, 64, 85, 106)
Variation to planned chemotherapy schedule
Any delays in chemotherapy schedule and the reasons why will be collected from the participants' medical records
Measured: Throughout chemotherapy, on 1st day of each cycle, according to chemotherapy schedule. This is usually fortnightly for colorectal (Days 1, 15, 19, 43, 57, 71, 85, 99) and 3-weekly for breast and gynaecologic cancers (Days 1, 22, 43, 64, 85, 106)
Chemotherapy related toxicities
Data will be collected from the participants' medical records, specifically the Common Terminology Criteria for Adverse Events (CTCAE), which is the standard form used in the Chemotherapy Suite to record information about any toxicities experienced by the patient resulting from chemotherapy (such as fatigue, vomiting, etc)
Measured: Throughout chemotherapy, on 1st day of each cycle, according to chemotherapy schedule. This is usually fortnightly for colorectal (Days 1, 15, 19, 43, 57, 71, 85, 99) and 3-weekly for breast and gynaecologic cancers (Days 1, 22, 43, 64, 85, 106)
Health related quality of life (HRQOL)
The study will seek to identify changes in quality of life, to help with hypothesis generation for future studies. Validated questionnaires from the Functional Assessment for Cancer Therapy (FACT) will be used, including:
FACT-G: a 27 item compilation of general questions covering physical, social/family, emotional and functional wellbeing; FACT-N: a 19-item neutropenia subscale designed to capture symptoms and impact on HRQOL related to neutropenia; FACT-An - a 20-item questionnaire assessing fatigue and anaemia-related concerns in people with cancer.
Measured: At Baseline, cycles 2, 3, and 6 (or final cycle), and one month after final cycle: typically Days 15, 29, 71, 127 for colorectal; Days 22, 43, 106, 134 for breast and gynaecological cancers
Patient self-management
Patients with a high level of activation are likely to engage in positive health behaviours and participate in managing their health conditions more effectively. The Patient Activation Measure (PAM) will be used to explore whether it is possible to identify patients who will be most likely to follow a daily healthcare regimen.
Measured: At Baseline, cycle 3, and one month after final cycle: typically Days 29 and 127 for colorectal; Days 43 and 134 for breast and gynaecological cancers
Safety assessed by all incidents including allergies, burns, and other accidents
The safety of moxibustion is under-reported in the literature. The researchers will monitor and record all incidents affecting safety, including allergies, burns, and other accidents
Measured: Through study completion, spanning 16 to 28 weeks depending on chemotherapy regimen
Incidents of additional interventions administered as prophylaxis or therapy to maintain or improve blood counts
The researchers will record whether participants are taking or having therapies that affect blood cell counts, such as steroids, iron supplements and other dietary supplements as prophylaxis, or blood and platelet transfusions to improve low blood counts.
Measured: Through study completion, spanning 16 to 28 weeks depending on chemotherapy regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Sponsor type
- Other government
- Collaborators
- British Acupuncture Council
- Responsible party
- Principal investigator, Beverley de Valois PhD LicAc FBAcC, East and North Hertfordshire NHS Trust
- Investigators
- Beverley A de Valois, PhD, Principal investigator, Lynda Jackson Macmillan Centre, Mount Vernon Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781155
- Sponsor's protocol ID
- RD2015-04
- Status last verified
- May 2016
- First submitted
- 6 May 2016
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Daily Self-administered Indirect Moxibustion to Zusanli St-36 to Reduce Chemotherapy Induced Pancytopenia: a Feasibility Study
- ClinicalTrials.gov ID
- NCT02781155
- Acronym / sponsor ID
- RD2015-04
- Conditions
- Breast Neoplasms, Colorectal Neoplasms, Genital Neoplasms, Female, Toxicity Due to Chemotherapy
- Keywords
- Health related quality of life, Moxibustion, Cancer, Chemotherapy, Neutropenia, Anaemia, Thrombocytopenia, Self management
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- East and North Hertfordshire NHS TrustOther government
- Collaborators
- British Acupuncture Council
- Study start
- Feb 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 24 May 2016 (estimated)
- 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.
This study investigates whether it is feasible to teach cancer patients undergoing chemotherapy to self-administer daily moxibustion to reduce chemotherapy side effects. Moxibustion is a therapy used in traditional Chinese medicine that uses heat.
Detailed description
Chemotherapy drugs are used to treat cancer cells. However, they can also affect bone marrow and reduce the ability to make certain types of blood cells. Low white blood cell counts can leave patients vulnerable to infection. Low red blood cell counts can lead to anaemia and feelings of fatigue and weakness. Low platelet counts can lead to bruising and bleeding. Blood counts are therefore monitored. If they fall too low, the dose of chemotherapy may be reduced or the time between doses extended. This may affect survival as well as quality of life.
Research studies in China and the West suggest that moxibustion applied by a practitioner can improve blood counts and immunity, and reduce side effects of chemotherapy. Moxibustion (also called moxa) is a form of traditional Chinese medicine that uses heat to stimulate acupuncture points. This heat comes from a smouldering herb called mugwort, that is rolled into a cigar shape to gently warm the point. Many patients regard this as a pleasant, relaxing experience.
The researchers will teach patients to self-administer moxa to an acupuncture point just below the knee. This is a feasibility study to see if patients are willing and able to self-administer moxa daily throughout chemotherapy. Patients will keep a moxa diary to record their activity. The researchers will also use a questionnaire to assess whether patients see themselves as active managers of their health. This may help the researchers to screen suitable patients in future studies.
The researchers will also monitor blood counts, any delays or dose reductions to the chemotherapy, and any chemotherapy side effects. Participants will complete quality of life questionnaires at intervals during and after their chemotherapy.
If results are favourable, they will be used to design a randomised controlled trial comparing daily moxibustion with a "no treatment" control arm.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self administration of moxibustion | Other | Other: MoxibustionParticipants will be taught to self administer moxibustion to the acupuncture point Zusanli St-36, and apply it daily throughout their chemotherapy treatments |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- with breast, gynaecologic, or colorectal cancer who are prescribed radical or adjuvant chemotherapy in the early disease setting, or first or second line chemotherapy is in the metastatic setting
- about to commence a course of chemotherapy for which granulocyte-colony stimulating factor (G-CSF) is not routinely indicated
- with a life expectancy of more than six months
- with blood cell counts within the normal range
- with calculated creatinine levels of ≥ 50ml/min
Key exclusion criteria (8 listed)
- having a haematological cancer diagnosis
- prescribed a chemotherapy regimen for which G-CSF is indicated
- having third or fourth line chemotherapy
- having metastatic bone cancer
- who have concomitant severe medical problems preventing participation
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 |
|---|---|---|
| MoxibustionAlso: MoxaParticipants are taught to self administer moxibustion to acupuncture point Zusanli St-36 daily throughout the course of their chemotherapy | Other | Self administration of moxibustion |
Primary outcome
Adherence to moxa regimen assessed by Daily Moxa Diary
Time frame: 21 days after last chemotherapy cycle
The primary aim of this study is to assess the feasibility of teaching cancer patients undergoing chemotherapy in the National Health Service (NHS) to self-administer daily indirect moxibustion to St 36 Zusanli, according to a protocol that begins ideally 7 to 10 days prior to the first chemotherapy cycle and continues until 21 days after the final chemotherapy cycle. Participants will complete a Daily Moxa Diary to record their adherence to the daily protocol. They will be asked also to log any days they miss, and give reasons why.
7 secondary outcomes
Blood counts, specifically white blood cells, neutrophils, haemoglobin, and platelets
Time frame: Throughout chemotherapy, on 1st day of each cycle, according to chemotherapy schedule. This is usually fortnightly for colorectal (Days 1, 15, 19, 43, 57, 71, 85, 99) and 3-weekly for breast and gynaecologic cancers (Days 1, 22, 43, 64, 85, 106)
Variation to planned chemotherapy schedule
Time frame: Throughout chemotherapy, on 1st day of each cycle, according to chemotherapy schedule. This is usually fortnightly for colorectal (Days 1, 15, 19, 43, 57, 71, 85, 99) and 3-weekly for breast and gynaecologic cancers (Days 1, 22, 43, 64, 85, 106)
Chemotherapy related toxicities
Time frame: Throughout chemotherapy, on 1st day of each cycle, according to chemotherapy schedule. This is usually fortnightly for colorectal (Days 1, 15, 19, 43, 57, 71, 85, 99) and 3-weekly for breast and gynaecologic cancers (Days 1, 22, 43, 64, 85, 106)
Health related quality of life (HRQOL)
Time frame: At Baseline, cycles 2, 3, and 6 (or final cycle), and one month after final cycle: typically Days 15, 29, 71, 127 for colorectal; Days 22, 43, 106, 134 for breast and gynaecological cancers
Patient self-management
Time frame: At Baseline, cycle 3, and one month after final cycle: typically Days 29 and 127 for colorectal; Days 43 and 134 for breast and gynaecological cancers
Safety assessed by all incidents including allergies, burns, and other accidents
Time frame: Through study completion, spanning 16 to 28 weeks depending on chemotherapy regimen
Incidents of additional interventions administered as prophylaxis or therapy to maintain or improve blood counts
Time frame: Through study completion, spanning 16 to 28 weeks depending on chemotherapy regimen
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- Individual participant dataSharing planned: No
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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.
Beverley A de Valois, PhD principal investigator
Lynda Jackson Macmillan Centre, Mount Vernon Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Moxibustion in people with Breast Neoplasms and Colorectal Neoplasms, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clare Scarlett, BA (Hons) (+44 203 826 2561, clare.scarlett1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to moxa regimen assessed by Daily Moxa Diary (time frame: 21 days after last chemotherapy cycle). 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 24 May 2016.