Breast CancerPhase 2NCT05566457
HGWD Improve the Paclitaxel-related Neurotoxicity in Patients With BC
A Phase 2 study testing Huangqi Guizhi Wuwu decoction (HGWD) infusion packs in people with Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The current treatments for albumin-bound paclitaxel (nab-PTX) -related peripheral neurotoxicity (PN) mainly included cryotherapy and compression therapy , oral B group vitamin , and duloxetine. However, treatment effectiveness of these three methods is limited. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Huangqi Guizhi Wuwu decoction (HGWD) infusion packs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Jan 2023
- Phase
- Phase 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
The inclusion criteria comprised:
ˑ histologically confirmed untreated BC; ˑ female; ˑage from 18 to 65 years old; ( ˑ Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; ˑat least receiving 4 cycles of nab-PTX (260mg/m2); ˑ grade 2 or greater nab-PTX induced-PN evaluated by European Organisation for the Research and Treatment of Cancer-Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20)(12, 13); ˑ estimated survival time > 6 months. The exclusion criteria were： ˑ a history of diabetes or neurological disorders; ˑmental disorder; ˑabnormal hepatic functions (total bilirubin upper limit of normal (ULN), alanine transaminase/aspartate transaminase ≥ 2.5 × ULN ), renal functions(creatinine ≥ 1.5 × ULN), and hematological functions (absolute neutrophil count ≤ 1.5 × 109/L, platelet count ≤ 80 × 109/L, hemoglobin < 90 g/L); ˑFailure to complete chemotherapy due to treatment-related adverse events; ˑ a family history of a genetic neuropathy; ˑhad received previous treatment with neurotoxic chemotherapy, including oxaliplatin, cisplatin, vinca alkaloid and etc.; ˑ a history of allergy to Chinese medicine.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Qiao Li, 8687788120 ext. 8687788120, Liqiaopumc@qq.com
About this study
Official title: Clinical Study of Huangshi Guizhi Wuwu Decoction in Improving the Paclitaxel-related Neurotoxicity in Breast Cancer Patients
The current treatments for albumin-bound paclitaxel (nab-PTX) -related peripheral neurotoxicity (PN) mainly included cryotherapy and compression therapy , oral B group vitamin , and duloxetine. However, treatment effectiveness of these three methods is limited. Huangqi Guizhi Wuwu decoction (HGWD) is an herbal formula recorded in "Synopsis of the Golden Chamber" for improving limb pain, tingling, and numbness, which is composed of five crude drugs (Astragali Radix, Cinnamomi Ramulus, Paeoniae Radix Alba, Zingiberis Rhizoma Recens, and Jujubae Fructus)(9). Recently, HGWD has been shown to be effective in the treatment of oxaliplatin- and diabetic-related PNs . But there are no prospective studies to explore the efficacy of HGWD in the treatment of nab-PTX-induced PN in patients with BC. Therefore, we conducted this prospective randomized controlled study to investigate the efficacy and safety of HGWD to prevent nab-PTX-induced PN in patients with BC. The primary aim of this study was to assess the prevention of nab-PTX-induced PN by soaking hands and/or feet with HGWD when compared to placebo.
Read the detailed description
This open-label, single-center, prospective, randomized controlled trial was planned to be conducted in the National Cancer Center in China from January 2020 to June 2022.The eligible paticipants were assigned randomly in a 1:1 ratio to a study group (HGWD group) or a control group. PASS software (version 15.0) (Kaysville, Utah, USA) was used to calculate the sample size. Assuming α = 0.05 and 1-β = 0.8, a total of 80 patients were needed for the aim of decreasing the grade 2-3 PN from 60% to 30%. Assuming a lost-to-follow-up rate of 15%, a total of 92 patients were needed. The primary aim of this study was to assess the prevention of nab-PTX-induced PN by soaking hands and/or feet with HGWD when compared to placebo.
- Conditions
- Breast Cancer
- Being tested
- Huangqi Guizhi Wuwu decoction (HGWD) infusion packs
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huangqi Guizhi Wuwu decoction (HGWD) infusion packsDrug
Patients in the HGWD group (n = 46) soaked and washed Immersion and Washing limbs with HGWD infusion packs, followed by smearing limbs with vitamin E and vitamin B12. The composition of HGWD infusion pack was: 60g Radix Astragali (Huangqi), 15g Ramulus Cinnamomi (Guizhi), 15g Paeonia lactiflora (Baishao), 15g Gentiana (Qinjiao), 6g Scorpio (Quan-Xie), 20g Rhizoma Zingiberis Recens (Shengjiang), 20 Jujubes (Dazao), 30g Geranium wilfordii (Laoguancao), 12g radix sileris (Fangfeng), 30g Spatholobus suberectus (Jixueteng), 15g Ligusticum (Chuanxiong), 15g Poria (Fuling), and 15g Radixcyathulae (Chuanniuxi). HGWD infusion pack was boiled in water and extraction was performed twice to obtain a total of 500 ml drug-containing water. The drug-containing water was maintained at 39 to 40℃ for soaking and washing limbs for 20min twice a day for consecutive 14 days
| Study group | Role | What they receive |
|---|---|---|
| HGWD group | Experimental | Patients in the HGWD group (n = 46) soaked and washed Immersion and Washing limbs with HGWD infusion packs, followed by smearing limbs with vitamin E and vitamin B12. The composition of HGWD infusion pack was: 60g Radix Astragali (Huangqi), 15g Ramulus Cinnamomi (Guizhi), 15g Paeonia lactiflora (Baishao), 15g Gentiana (Qinjiao), 6g Scorpio (Quan-Xie), 20g Rhizoma Zingiberis Recens (Shengjiang), 20 Jujubes (Dazao), 30g Geranium wilfordii (Laoguancao), 12g radix sileris (Fangfeng), 30g Spatholobus suberectus (Jixueteng), 15g Ligusticum (Chuanxiong), 15g Poria (Fuling), and 15g Radixcyathulae (Chuanniuxi). HGWD infusion pack was boiled in water and extraction was performed twice to obtain a total of 500 ml drug-containing water. The drug-containing water was maintained at 39 to 40℃ for soaking and washing limbs for 20min twice a day for consecutive 14 days Receives: Drug: Huangqi Guizhi Wuwu decoction (HGWD) infusion packs |
| control group | Placebo comparator | Patients in the control group and the HGWD group used vitamin E milk and vitamin B12 to smear the limbs three times per day for 14 days. Receives: Drug: Huangqi Guizhi Wuwu decoction (HGWD) infusion packs |
What is being measured
The primary outcome is the main question the study is designed to answer.
European Organisation for the Research and Treatment of Cancer-Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) questionnaire
The primary outcome measures was European Organisation for the Research and Treatment of Cancer-Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) questionnaire, which consisted of 20 items that graded the degree of functioning affected by sensory (9 items), motor (8 items) and autonomic CIPN symptoms (3 items). Each item was scored from 1 to 4 (corresponding to answers of none, mild, moderate, and severe) on a Likert scale and subsequently the scores were summed up (total score range, 1-44). Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and autonomic raw scale scores range from 1 to 12 for men and 1-8 for women (erectile function item is excluded). Higher scores represented more symptoms and worse quality of life.
Measured: up to 3 months
Secondary outcomes (1)
European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) (version 3)
The EORTC QLQ-C30 is a validated 30-item questionnaire containing both single- and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/ Quality of Life (QoL) scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). Scores for each scale and single-item measure are averaged and transformed linearly to a score ranging from 0-100. A high score for functional scales and for Global Health Status/QoL represent better functioning ability or HRQoL, whereas a high score for symptom scales and single items represents significant symptomatology.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Jan 2020
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This open-label, single-center, prospective, randomized controlled trial was planned to be conducted in the National Cancer Center in China from January 2020 to June 2022.The eligible paticipants were assigned randomly in a 1:1 ratio to a study group (HGWD group) or a control group. PASS software (version 15.0) (Kaysville, Utah, USA) was used to calculate the sample size. Assuming α = 0.05 and 1-β = 0.8, a total of 80 patients were needed for the aim of decreasing the grade 2-3 PN from 60% to 30%. Assuming a lost-to-follow-up rate of 15%, a total of 92 patients were needed.
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Qiao, Chinese Academy of Medical Sciences
- Investigators
- Qiao Li, Dr., Principal investigator, Department of Medical Oncology, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566457
- Sponsor's protocol ID
- LQiao
- Status last verified
- Oct 2022
- First submitted
- 14 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Huangshi Guizhi Wuwu Decoction in Improving the Paclitaxel-related Neurotoxicity in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05566457
- Acronym / sponsor ID
- LQiao
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 4 Oct 2022 (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.
The current treatments for albumin-bound paclitaxel (nab-PTX) -related peripheral neurotoxicity (PN) mainly included cryotherapy and compression therapy , oral B group vitamin , and duloxetine. However, treatment effectiveness of these three methods is limited. Huangqi Guizhi Wuwu decoction (HGWD) is an herbal formula recorded in "Synopsis of the Golden Chamber" for improving limb pain, tingling, and numbness, which is composed of five crude drugs (Astragali Radix, Cinnamomi Ramulus, Paeoniae Radix Alba, Zingiberis Rhizoma Recens, and Jujubae Fructus)(9). Recently, HGWD has been shown to be effective in the treatment of oxaliplatin- and diabetic-related PNs . But there are no prospective studies to explore the efficacy of HGWD in the treatment of nab-PTX-induced PN in patients with BC. Therefore, we conducted this prospective randomized controlled study to investigate the efficacy and safety of HGWD to prevent nab-PTX-induced PN in patients with BC. The primary aim of this study was to assess the prevention of nab-PTX-induced PN by soaking hands and/or feet with HGWD when compared to placebo.
Detailed description
This open-label, single-center, prospective, randomized controlled trial was planned to be conducted in the National Cancer Center in China from January 2020 to June 2022.The eligible paticipants were assigned randomly in a 1:1 ratio to a study group (HGWD group) or a control group. PASS software (version 15.0) (Kaysville, Utah, USA) was used to calculate the sample size. Assuming α = 0.05 and 1-β = 0.8, a total of 80 patients were needed for the aim of decreasing the grade 2-3 PN from 60% to 30%. Assuming a lost-to-follow-up rate of 15%, a total of 92 patients were needed. The primary aim of this study was to assess the prevention of nab-PTX-induced PN by soaking hands and/or feet with HGWD when compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This open-label, single-center, prospective, randomized controlled trial was planned to be conducted in the National Cancer Center in China from January 2020 to June 2022.The eligible paticipants were assigned randomly in a 1:1 ratio to a study group (HGWD group) or a control group. PASS software (version 15.0) (Kaysville, Utah, USA) was used to calculate the sample size. Assuming α = 0.05 and 1-β = 0.8, a total of 80 patients were needed for the aim of decreasing the grade 2-3 PN from 60% to 30%. Assuming a lost-to-follow-up rate of 15%, a total of 92 patients were needed.
| Arm | Type | Receives |
|---|---|---|
| HGWD group | Experimental | Drug: Huangqi Guizhi Wuwu decoction (HGWD) infusion packsPatients in the HGWD group (n = 46) soaked and washed Immersion and Washing limbs with HGWD infusion packs, followed by smearing limbs with vitamin E and vitamin B12. The composition of HGWD infusion pack was: 60g Radix Astragali (Huangqi), 15g Ramulus Cinnamomi (Guizhi), 15g Paeonia lactiflora (Baishao), 15g Gentiana (Qinjiao), 6g Scorpio (Quan-Xie), 20g Rhizoma Zingiberis Recens (Shengjiang), 20 Jujubes (Dazao), 30g Geranium wilfordii (Laoguancao), 12g radix sileris (Fangfeng), 30g Spatholobus suberectus (Jixueteng), 15g Ligusticum (Chuanxiong), 15g Poria (Fuling), and 15g Radixcyathulae (Chuanniuxi). HGWD infusion pack was boiled in water and extraction was performed twice to obtain a total of 500 ml drug-containing water. The drug-containing water was maintained at 39 to 40℃ for soaking and washing limbs for 20min twice a day for consecutive 14 days |
| control group | Placebo comparator | Drug: Huangqi Guizhi Wuwu decoction (HGWD) infusion packsPatients in the control group and the HGWD group used vitamin E milk and vitamin B12 to smear the limbs three times per day for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Huangqi Guizhi Wuwu decoction (HGWD) infusion packsPatients in the HGWD group (n = 46) soaked and washed Immersion and Washing limbs with HGWD infusion packs, followed by smearing limbs with vitamin E and vitamin B12. The composition of HGWD infusion pack was: 60g Radix Astragali (Huangqi), 15g Ramulus Cinnamomi (Guizhi), 15g Paeonia lactiflora (Baishao), 15g Gentiana (Qinjiao), 6g Scorpio (Quan-Xie), 20g Rhizoma Zingiberis Recens (Shengjiang), 20 Jujubes (Dazao), 30g Geranium wilfordii (Laoguancao), 12g radix sileris (Fangfeng), 30g Spatholobus suberectus (Jixueteng), 15g Ligusticum (Chuanxiong), 15g Poria (Fuling), and 15g Radixcyathulae (Chuanniuxi). HGWD infusion pack was boiled in water and extraction was performed twice to obtain a total of 500 ml drug-containing water. The drug-containing water was maintained at 39 to 40℃ for soaking and washing limbs for 20min twice a day for consecutive 14 days | Drug | HGWD group, control group |
Primary outcome
European Organisation for the Research and Treatment of Cancer-Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) questionnaire
Time frame: up to 3 months
The primary outcome measures was European Organisation for the Research and Treatment of Cancer-Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) questionnaire, which consisted of 20 items that graded the degree of functioning affected by sensory (9 items), motor (8 items) and autonomic CIPN symptoms (3 items). Each item was scored from 1 to 4 (corresponding to answers of none, mild, moderate, and severe) on a Likert scale and subsequently the scores were summed up (total score range, 1-44). Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and autonomic raw scale scores range from 1 to 12 for men and 1-8 for women (erectile function item is excluded). Higher scores represented more symptoms and worse quality of life.
1 secondary outcome
European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) (version 3)
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- 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.
Qiao Li, Dr. principal investigator
Department of Medical Oncology, National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Huangqi Guizhi Wuwu decoction (HGWD) infusion packs in people with Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Oct 2022. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 Chai Yue, Dr. (+8615910573527 ext. 87788819, cy972628990@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European Organisation for the Research and Treatment of Cancer-Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) questionnaire (time frame: up to 3 months). 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 4 Oct 2022.