Clinical trial NCT02781155: Limiting Chemotherapy Side Effects by Using Moxa
Official title: Using Daily Self-administered Indirect Moxibustion to Zusanli St-36 to Reduce Chemotherapy Induced Pancytopenia: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
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
Wellbeing
Lead sponsor: East and North Hertfordshire NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: British Acupuncture Council
First posted: 2016-05-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Adherence to moxa regimen assessed by Daily Moxa Diary
timeFrame: 21 days after last chemotherapy cycle
Secondary outcomes:
measure: Blood counts, specifically white blood cells, neutrophils, haemoglobin, and platelets
timeFrame: 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)
measure: Variation to planned chemotherapy schedule
timeFrame: 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)
measure: Chemotherapy related toxicities
timeFrame: 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)
measure: Health related quality of life (HRQOL)
timeFrame: 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
measure: Patient self-management
timeFrame: 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
measure: Safety assessed by all incidents including allergies, burns, and other accidents
timeFrame: Through study completion, spanning 16 to 28 weeks depending on chemotherapy regimen
measure: Incidents of additional interventions administered as prophylaxis or therapy to maintain or improve blood counts
timeFrame: Through study completion, spanning 16 to 28 weeks depending on chemotherapy regimen
Other outcomes:
Locations:
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
state: Middlesex
Study officials:
affiliation: Lynda Jackson Macmillan Centre, Mount Vernon Cancer Centre
name: Beverley A de Valois, PhD
role: PRINCIPAL_INVESTIGATOR
References: